Product and Process Variants & Impurities

The Industry’s Leading Case Study-Driven Conferences to Help You 

Characterize Biological Products and Identify/Control Variants & Impurities 

October 21-23, 2013 • L’Enfant Plaza Hotel • Washington DC 

Access Any Session at These Co-located Events for One Price 

IBC’s 17th Annual 

Well Characterized Biologicals 

Case Studies, CMC Strategies and Regulatory Perspectives on Protein Characterization and 

Product Comparability for Biotechnology Products and Biosimilars throughout the Product Lifecycle 

Featured Presentation to Help You Avoid Common Pitfalls in Your CMC Submissions: 

Top 10 List of Analytical Inadequacies in IND or BLA Submissions 

Alfred Del Grosso, Team Leader, Analytical Chemistry, Division of Biological Standards and Quality Control, CBER, US FDA 

Find Strategies for Successful 

Product Characterization of: 

• ADCs, Bispecifics, Fusion Proteins 

• Vaccines, Combination Products 

• Biosimilars, Monoclonal Antibodies 

Interact with Regulators 

Who Will Share Expectations for: 

• Higher Order Structure, Vaccine Assays 

• Biosimilars, Comparability 

• Host Cell Proteins, Particulates, Impurities 

IBC’s Inaugural 

www.IBCLifeSciences.com/WCB 

Product and Process Variants & Impurities 

Identification and Effective Control of Variants and Impurities for Optimal Processing and Product Quality 

Featured Presentations provide Regulatory and Industry Perspectives on Controlling 

Variants and Impurities, Monitoring Quality and Addressing Future Challenges 

Mikhail V. Ovanesov, Ph.D., CBER, US FDA • C. Mark Smales, Ph.D., University of Kent • Erwin Freund, Ph.D., Amgen Inc. 

Optimize Process and Product Quality by Building 

In Variant and Impurity Control Protocols through: 

• Supply Chain Management, Manufacturing 

Enhancements, Assays 

• Physicochemical and Characterization Data 

www.IBCLifeSciences.com/Variants 

Achieve Greater Acceptance Criteria and Mitigate 

Variant and Impurity Risks by Applying: 

• Stable Isotope-Tagged Reference Standards 

• Multi-Dimensional Characterization, LC/MS and 

Biophysical Methods 

Silver Sponsor: 

Featured Publication: 

Organized by:

Find Practical Strategies and New Techniques to Help You 



More Case Studies and Unpublished Data You Can Apply in Your CMC Programs 

Register today to hear practical advice in these critical areas that you can apply in your own lab: 

• Characterize ADCs, Bispecifics and Fusions to Help You 

Overcome the Challenges of More Complex Molecules 

• Implement Improved CMC Strategies for Biosimilars and 

Vaccines So You Can Meet Regulatory Expectations 

in Your IND/BLA Submissions 

• Improve Product and Process Comparability to Prepare 

for Both Scale-up Efforts and Manufacturing Site Changes 

Featured FDA Presentation 

Top 10 List of Analytical Inadequacies 

in IND or BLA Submissions 

Alfred Del Grosso, CBER, US FDA 

Tuesday, October 22 • 10:15 am 

• Develop Functional Biological Assays and Evaluate Novel 

Analytical Technologies to Support Characterization of 

Monoclonal Antibodies and Other Diverse Products 

• Analyze Host Cell Proteins, Impurities and Degradation 

Pathways to Help You Control Product and Process Quality 

• Explore the Biophysical and Structural Properties of Your 

Molecules to Provide Better Information for Your Regulatory Dossier 

Avoid Common Pitfalls in Your Analytical and CMC Studies 

Case Studies and Lessons Learned from: 

Amgen, Genentech, ImmunoGen, Oncomed, AbbVie, Sandoz, 

Biogen Idec, Millenium/Takeda, Merck, MedImmune, Novavax, 

Sanofi Pasteur and more! 

One Registration Fee Gives You Access to Two 

Call for Poster Presentations and Best Poster Award 

Consider presenting a poster at this conference to derive more value from attending. Share your research 

with your peers and learn from other posters as well. Many attendees tell us that being selected for 

a poster presentation helps to facilitate their company approval process to attend the conference. All 

posters will be reviewed by the conference advisory board and a Best Poster Award will be presented 

during the conference. Submit your poster abstract online today at www.IBCLifeSciences.com/WCB or 

www.IBCLifeSciences.com/Variants. Poster abstract submission deadline: September 20, 2013. 

Oral Poster Presentation Session 

Several poster presenters will be chosen to provide a short oral presentation of their poster during the 

conference sessions. Submit your poster abstract today for a chance to be selected for this opportunity. 

Make New Contacts and Enjoy Dinner with Fellow Attendees 

A dinner sign-up sheet will be provided during the conference to allow you to connect with other 

attendees who are interested in meeting others for dinner after the conference sessions. 

Regulatory Advice You Can Apply 

With 8 confirmed speakers from FDA and Health Canada, along with other regulatory/policy experts 

from the US Pharmacopeia and industry, you’ll walk away from this conference 

with an update on changing regulatory guidances and clearer regulatory expectations 

for your molecules. Many more FDA speakers have been invited to present. 

Please visit the conference websites for updates as they confirm. 

“Great conference! I learned a lot and got some great ideas for the development of in-house methods. I thought the 

FDA presentations were terrific…and put the fear of God in me” – Jacqueline McGourty, Associate Director, Emergent Biosolutions 

2 Register Early for Best Savings • Up-to-date Program Information • www.IBCLifeSciences.com/WCB

Meet Regulatory Expectations for a Wide Range of Molecules 



The Only Industry Forum Covering Variant and Impurity Control and Mitigation Strategies 

• Navigate the Characterization Landscape for Increased Product 

Understanding and Speed with Pfizer’s Technology Roadmap 

• Hear the Level of Agreement on Sizing and Counting 

from 24 Laboratories in the NIST’s Subvisible Particle Round- 

Robin Comparison 

• Apply Regeneron Pharmaceutical’s Strategy to Characterize 

Subvisible Particles Impact on Virus Filters for Robust Process 

and Production 

• Learn How AbbVie Uses Stable Isotope-Tagged Reference 

Standards and Analytical Tools for Detecting Variants and PTMs 

at Low Levels and Maintaining Manufacturing Consistency 

• Discover How Genentech is Using Nucleic Acid Technologies 

as Complementary Tools for Early Mutation Detection 

• Set Proactive Steps for Manufacturing, QbD Expectations 

and other Process Specifications with Amgen’s Aggregation 

Control Strategy 

Featured FDA Presentation 

Changing the Manufacturing Process to 

Remove Impurities and Monitoring Product 

Quality Using Relevant Lot Release Assays 

Mikhail V. Ovanesov, Ph.D., CBER, US FDA 

Tuesday, October 22 • 8:15 am 

Conferences and Shared Exhibits, Posters & Networking 

View New Technology in the Exhibit Hall 

Enhance Your Process Development Efforts to Mitigate 

Product- and Process-Related Variant and Impurities 

Case Studies and Leadership Insights from: AbbVie, 

ABC Laboratories, Amgen, Bristol-Meyers-Squibb, Boehringer 

Ingelheim, Genentech, Genzyme, Merck, NIST, NIBRT, Pfizer, 

Protein Sciences Corp., Regeneron Pharmaceuticals, SAFC 

Carlsbad, SAIC-Frederick, University of Kent and Waters 

Find new analytical technologies, products and services to help you with your product characterization efforts 

in the exhibit hall. Both conferences share all exhibit and networking breaks so you will have an opportunity to 

meet with vendors and technology providers from both events all under one roof. 

Participate in “Hot Topic” Roundtable Discussions 

Moderated by FDA 

and Industry Speakers 

Discuss and debate important industry issues with other attendees and speakers during these informal, “Hot 

Topic” roundtable discussions moderated by conference speakers. To suggest a topic you would like to 

discuss, please email Michael Keenan at mkeenan@ibcusa.com or Mark DeSorbo at mdesorbo@ibcusa.com. 

Who Should Attend 

These co-located conferences offer too much content for just one person. Send a team from your company to capitalize on this unique 

opportunity to meet face to face with multiple regulators and to benefit from hearing unpublished data that will only be shared in person at 

these conferences. 

The practical advice and industry case studies at this event will benefit Scientists, Technicians, 

Managers, Lab Heads, Directors and other specialists in the following departments: 

• Analytical R&D 

• CMC 

• Protein Analytical Chemistry 

• Bioassay Development 

• Regulatory Affairs and QA/QC 

• Process Development 

• Product Development 

• Technical Operations/Manufacturing Sciences 

• Drug Product Manufacturing 

• Clinical Supply Chain Procurement 

Send a Group of 3 

and the 4th goes FREE! 

For more information on 

group pricing or to register 

a group, call our group sales 

advocate at 646-895-7445 

“I enjoyed the conference. There was plenty of new knowledge gained from the presentations and new opportunities 

for networking with colleagues in the industry” – Bridgitte Speights, Director, CMC Regulatory Affairs, Teva 

Register Early for Best Savings • Up-to-date Program Information • www.IBCLifeSciences.com/Variants 3


8:30 Chairman’s Remarks 

Michael G. Mulkerrin, Ph.D., Vice President, Process Development, OncoMed 

Pharmaceuticals 

Characterization of Novel Antibody Constructs and 

Monoclonal Antibodies 

8:45 UNPUBLISHED DATA Physicochemical Characterization of 

Maytansinoid ADCs 

Manufacturing of maytansinoid ADCs using ImmunoGen’s technology relies 

on the attachment of the cytotoxic agent molecules (DM1 or DM4) via a 

linker to amino groups on antibodies. This attachment changes some of 

the properties of the antibody molecules. This presentation will describe 

development and implementation of an appropriate panel of analytical 

techniques for release and characterization of maytansinoid ADCs. 

Alex Lazar, Ph.D., Head of Analytical and Pharmaceutical Sciences, 

ImmunoGen, Inc. 

9:15 UNPUBLISHED DATA Strategy for the Characterization of 

Bispecific Antibodies 

Bispecific Antibodies are a class of therapeutics gaining in prevalence. 

Advances in protein engineering are generating a number of solutions for 

the generation of bispecific antibodies. There are common challenges in the 

manufacture of these molecules, which include quantitating the amount of 

the homodimer and heterodimer and characterizing the nature of unwanted 

variants. This presentation will discuss the strategy and analytical approaches 

to characterize bispecific antibodies. 

Michael G. Mulkerrin, Ph.D., Vice President, Process Development, 

OncoMed Pharmaceuticals 

9:45 CASE STUDY Analytical Characterization Strategies for 

Bispecific Molecules and Novel Antibody Constructs 

Bispecific antibody-like molecules and other formats investigated present new 

therapeutic opportunities. However, analytical challenges are encountered 

when adopting platform monoclonal antibody formats to evaluate these 

complex molecules. In this presentation we will highlight a few case studies to 

illustrate our approach to studying antigen binding and other pharmaceutical 

properties of these molecules. 

Leslie T. Alessandri, Senior Scientist II, Protein Analytics, 

AbbVie Bioresearch Center 

10:15 Networking Refreshment Break and Exhibit/Poster Viewing 

10:45 Development of a Flow-through Dialysis System – 

A Novel Approach in Evaluating Biological Relevance of 

Recombinant Proteins 

For recombinant proteins, understanding of in vivo behavior of product variants 

is important and desirable but often is very challenging to achieve. In this 

presentation, we describe the development of an in vitro flow-through dialysis 

system to mimic in vivo behavior of disulfide isoforms in monoclonal antibodies 

and Fc-fusion proteins. The system is capable of maintaining a low level redox 

concentrations found in human blood. Using this system, we studied the 

conversion kinetics of disulfide variants in vitro under physiological conditions. 

Gang Huang, Ph.D., Scientific Director, Process and Product Development, 

Amgen, Inc. 

11:15 CASE STUDY/UNPUBLISHED DATA Characterization of an Fc Fusion 

Protein Therapeutic Candidate: Lessons Learned, Experiences 

and Future Challenges 

An Fc fusion protein therapeutic comprised of a receptor extracellular domain 

(ECD) fused with the Fc portion of an IgG1 antibody was analyzed by multiple 

methods to confirm the predicted structure and establish the product profile. 

The ECD, containing two additional N-linked glycosylation sites as well as a 

disproportionately high number of acidic amino acids, afforded some unique 

analytical challenges. The particular challenges confronted by Fc-fusion product 

candidate characterization will be discussed. 

James Bourell, Senior Scientist, Process Development, OncoMed Pharmaceuticals 

Reference Standards for Biologicals 

11:45 Regulatory Perspectives on the Use of Reference Standards 

for Licensed Therapeutic Proteins 

Ashutosh Rao, Ph.D., Product Quality Reviewer, Division of Therapeutic 

Proteins, CDER, US FDA 

Monday, October 21, 2013 

7:00 Registration and Coffee 


8:00 Chairman’s Opening Remarks 

David Ouellette, Senior Scientist II, Protein Analytics, Process Sciences, 


Featured Presentation 

8:15 The Challenges of Product- and 

Process-Related Impurities to an Evolving 

Biopharmaceutical Industry 

C. Mark Smales, Centre for Molecular Processing & School 

of Biosciences, University of Kent, United Kingdom 

Analytical Methods and Technologies for Identifying and 

Controlling Product-Related Variants and Impurities 

8:45 Optimizing Host Cell Protein Assay to Enable Rapid 

Process Development 

Abstract not available at time of print. Please visit 

www.IBCLifeSciences.com/Variants for updates. 

Brett Carter, Associate Scientist, MedImmune 

9:15 Stable Isotope-Tagged Reference Standards for Detection 

of Sequence Variants and PTMs 

The current analytical methods that are used to identify the presence of 

mutations or modifications in an antibody sample may not always be able to 

detect these changes when they are present at a low level. A quantitative mass 

spectrometry-based approach, the SITRS method, was developed and further 

optimized to identify these minute differences down to 1%. Fully-automated 

data analysis enables high resolution comparability of therapeutic proteins 

at the peptide level without a prior knowledge of the presence or nature of 

the variant. The utility of the SITRS method in discovering and quantitating 

sequence variants and PTMs will be demonstrated by specific case studies. 

Anton V. Manuilov, Ph.D., Senior Scientist II, Protein Analytics, 


9:45 Use of Standard Analytical Tools for Screening Product 

Variants During Candidate Selection of Antibodies 

Manufacturing well-characterized biologics has become an expectation for 

antibody and bispecifics production within the biotech industry. Analytical 

methods that examine physicochemical properties of molecules when screening 

multiple candidates are helpful in identifying sequence liabilities. This information 

is important for identifying candidates with appropriate shelf life, desired quality 

attributes and ensuring manufacturing consistency during clinical development. 

David Ouellette, Senior Scientist II, Protein Analytics, Process Sciences, 



10:45 CASE STUDY/UNPUBLISHED DATA Mutation Detection and Discovery 

by the Nucleic Acid Technologies 

Sequence variants as a product quality attribute needs to be analyzed for 

pharmaceuticals generated by recombinant technology. Mutations at the DNA 

level can lead to protein sequence variants and may not change the amino acid 

coding. Nucleic acid technologies allow earlier detection of mutations, and 

serve as complementary tools to sequence variant analysis at the protein level. 

Judith Shimoni, Ph.D., Senior Scientist / Group Leader, Protein Analytical 

Chemistry, Genentech 

11:15 CASE STUDY/UNPUBLISHED DATA Assess Product-Related Variants by 

Targeted Multi-Dimensional Characterization Methods 

Monoclonal antibodies (mAbs) are well characterized proteins and established 

as the most promising drug classes in the biopharmaceutical industry. This talk 

discusses a balanced strategy to assess product-related variants of mAbs in early 

stage as part of the QbD approach. Case studies will be used to elucidate the 

application of the strategy in evaluating potential product-related variants of mAbs. 

Wei Xu, Ph.D., Principal Scientist, Bioprocess Development Extended 

Characterization, Merck Research Laboratories 

11:45 Presentation Sponsorship Opportunity 

For more information on sponsored opportunities to present an exciting 

technology or application in this conference session, please contact 

Jennifer Thebodo at jthebodo@ibcusa.com 

4 www.IBCLifeSciences.com/WCB www.IBCLifeSciences.com/Variants

Monday, October 21, 2013 (continued) 

12:15 Networking Luncheon and Exhibit/Poster Viewing with “Hot Topic” Roundtable Discussions 

Please join us during this afternoon’s luncheon for informal, “hot topic” roundtable discussions moderated by conference speakers. To suggest a topic 

you would like to discuss, please email Michael Keenan at mkeenan@ibcusa.com. 

Confirmed Discussion Topics and Moderators: 

What Are Requirements for Highly Similar and 

Fingerprint-Like Biosimilars? 

Andreas Seidl, Ph.D., Head, Analytical Characterization and Site Head, Sandoz 

Biopharmaceuticals, Hexal AG, Sandoz Biopharmaceuticals, Germany 

Regulatory CMC Considerations for Phase 2b and Phase 3 Vaccines 

Cara Fiore, Ph.D., Master Reviewer, Office of Vaccines Research and Review, 

CBER, US FDA 

Regulatory Considerations in the Safety Assessment of Vaccine 

Adjuvants and Adjuvanted Vaccines 

Carmen M. Collazo-Custodio, Ph.D., Microbiologist, Primary Reviewer, 

Division of Vaccines and Related Product Applications, CBER, US FDA 

Analytical Characterization Strategies and Challenges of Protein 

Vaccine Products 

Ziping Wei, Ph.D., Executive Director, Novavax, Inc. 

Utilization of Forced Degradation Data in Product Regulatory Filings 

Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group 

Bridging from Old To Modern Potency Assays: How Much Bridging 

Data is Sufficient and are We Measuring the Right Attributes? 

Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics & Biotechnology, 

US Pharmacopeia 

Comparability Strategies 

Alan V. Klotz, Ph.D., Advisor, Research and Development, 

Elanco Animal Health, a division of Eli Lilly & Co. 

High End Characterization of Biosimilars (Using NMR , XRD) – 

a Scientifically Justified Requirement or a Check Box? 

Sridevi Khambhampaty, Ph.D., Director, Product Characterization and 

Bioanalytical Development, Dr. Reddy’s Laboratories Ltd., India 

Modern Molecular Methods for Impurity and Contamination Analysis 

Wesley Straub, Senior Product Manager, Bioproduction, Life Technologies 



Andreas Seidl, Ph.D., Head, Analytical Characterization and Site Head, 

Sandoz Biopharmaceuticals, Hexal AG, Sandoz Biopharmaceuticals, 

Germany 

CMC Strategies for Biosimilars 

1:45 FDA Perspective Update on the United States 

Biosimilars Program 

FDA continues to receive applications to the abbreviated licensure pathway 

afforded by section 351(k) of the Public Health Service Act which permits a 

biosimilar biological product to be licensed on less than a full compliment of 

product-specific preclinical and clinical data. This talk provides an overview 

of the biosimilars program at FDA and discusses emerging technical 

considerations to assure safe and efficacious biosimilar products. 

Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products 

(OBP), CDER, US FDA 

2:15 CASE STUDY/UNPUBLISHED DATA Characterization Strategies for 

Demonstration of Biosimilarity 

Thorough characterization of a biosimilar candidate in comparison with 

the reference product is the basis for a targeted clinical development 

program. FDA biosimilar guidelines suggest not only to analyze isolated 

quality attributes but also to focus on combinations of quality parameters. 

This presentation will give an overview about characterization strategies 

for biosimilars and will also provide case studies on quality attribute 

combinations and the impact on structure/function. 

Andreas Seidl, Ph.D., Head, Analytical Characterization and Site Head, 

Sandoz Biopharmaceuticals, Hexal AG, Sandoz Biopharmaceuticals, 

Germany 

2:45 CASE STUDY/UNPUBLISHED DATA Characterization of Charge 

Variants in Monoclonal Antibodies: Case Study of a 

Proposed Rituximab Biosimilar Characterization 

In this presentation, the case study of a proposed rituximab biosimilar along 

with the innovator product demonstrates a detailed characterization of the 

charge variant profile for a Mab. The characterization approach uses peptide 

map LCMS and reduced LCMS techniques to arrive at the identification of 

the charge isoforms. In addition, the functional assessment of the isolated 

and purified charge variants will be shown to demonstrate any functional 

relevance of these changes. 

Sridevi Khambhampaty, Ph.D., Director, Product Characterization and 

Bioanalytical Development, Dr. Reddy’s Laboratories Ltd., India 




Jason C. Rouse, Ph.D., Director, Mass Spectrometry and Biophysical 

Characterization, Analytical Research and Development, Biotherapeutics 

Pharmaceutical Sciences, Pfizer, Inc. 

Analytical Methods and Technologies for Identifying 

and Controlling Product-Related Variants and 

Impurities (continued) 

1:45 Rapid Mass Spec Approach for Monitoring Process 

Impurities and CQAs 

This presentation focuses on the utility of peptide and glycan mapping 

strategies for identifying and monitoring product variants and critical quality 

attributes. A particular emphasis is placed on informatics tools which 

provide efficiency gains in product variant identification. IgG2 and IgG1 

molecules are used as representative material. 

Justin Prien, Ph.D., Senior Scientist, Process and Product Engineering, Amgen Inc. 

2:15 The Ever-Changing “Characterization Roadmap” for 

Protein Therapeutics: Integration of New Technologies for 

Increased Product Understanding and Speed 

Contemporary mass spectrometers offer significant improvements in critical 

performance parameters such as resolution, mass accuracy, and sensitivity, 

thereby, enabling new approaches to protein characterization. Ultrahighresolution 

MS, in combination with UHPLC and the FabRICATOR® enzyme, 

have led to a highly resolving, antibody subunit mapping method that rivals 

traditional peptide mapping in terms of rapid confirmation of the expected 

amino acid sequence and post-translational modifications. 

Jason C. Rouse, Ph.D., Director, Mass Spectrometry and Biophysical 

Characterization, Analytical Research and Development, Biotherapeutics 

Pharmaceutical Sciences, Pfizer, Inc. 

Process Monitoring and Control Strategies for 

Purifying Variants and Impurities 

2:45 CASE STUDY Variations in the Glycosylation of 

Biopharmaceuticals: Approaches to Controlling the 

Pathways and Analyzing the Glycans 

Glycosylation pathways are determined at many levels from the genome to 

the proteome and by the environment of the cells in culture. Glycans have an 

influence on the safety and efficacy of many biological drugs, so it is necessary to 

understand the outcome that is relevant to the mode of action of the product. 

There are many possibilities for manipulating the glycosylation pathways and to 

monitor the interventions and some of these will be discussed in this talk. 

Pauline M. Rudd, Ph.D., NIBRT Research Professor, 

Dublin-Oxford Glycobiology Laboratory, NIBRT, Ireland 


www.IBCLifeSciences.com/WCB www.IBCLifeSciences.com/Variants 5

Monday, October 21, 2013 (continued) 


Biological Assay Development Strategies 

3:45 CASE STUDY/UNPUBLISHED DATA Case Study for the Development 

of Potency Assays to Support the Characterization of a 

Monoclonal Antibody Reflecting Antibody Dependent Cell 

Mediated Phagocytosis (ADCP) As a Presumed Mechanism 

of Action 

At Biogen Idec, a phase-based approach is applied to the selection of assay 

formats to measure the biological activity of protein therapeutics. For 

early phase clinical programs, a binding assay is used for batch release and 

stability testing, followed by development of a cell-based functional assay, 

relevant to the therapeutics’ mechanism of action, as the program advances 

to late stage. In this presentation, a case study describing the development 

and evaluation of several orthogonal assays used to characterize the 

Antibody Dependent Cell Mediated Phagocytosis (ADCP) activity of a 

monoclonal antibody is presented. In addition, development of a novel 

ADCP assay that reflects this challenging MOA is described. The rationale 

for usage of each individual assay and strategy for cross-over studies 

between assays is discussed. 

Carl Co, Ph.D., Scientist, Analytical Development, Biogen Idec 

4:15 CASE STUDY/UNPUBLISHED DATA Application of Equivalency Testing 

To Variable Bioassays 

Equivalency testing for bioassays circumvents some of the issues observed 

with other parallel-line analysis statistics, but presents its own challenges. 

A statistical method from USP was applied to a binding assay 

and a cell based bioassay. Application of the method to the binding assay 

was relatively straightforward. The bioassay, on the other hand, showed 

much more variability in its readout, requiring additional testing during 

development to establish confidence interval goal posts. During validation 

and assay transfer, additional variation was observed necessitating a further 

adjustment of the goal posts. This case study demonstrates that setting 

equivalency testing goal posts requires reiteration. The USP chapter outlines 

the fundamentals of equivalency testing, however there are points to keep in 

mind from this application for future bioassay development. 

Edward Rocnik, Ph.D., Scientist II, Analytical Development – Biologics, 

Millennium, The Takeda Oncology Company 

4:45 Engineering Potency Assay Solutions for Complex MOAs 

Abstract not available at time of print. 

Please visit www.IBCLifeSciences.com/WCB for updates. 

Kendall D. Carey, Ph.D., QC Scientist, Genentech, Inc., A member of the 

Roche Group 

5:15 FDA Perspective Serologic Assays Used in Vaccine 

Development for Bacterial Diseases 

The US Food and Drug Administration, Center for Biologics Evaluation 

and Research, Office of Vaccines Research and Review (OVRR) evaluates 

the safety and efficacy of vaccines for therapeutic and vaccine preventable 

diseases in the U. S. Serologic assays may be used as correlates of 

protection to clinically evaluate effectiveness of a vaccine when disease 

cannot be measured. This presentation will review why, when, and how it is 

appropriate to develop serologic assays. Meningococcal vaccines (Neisseria 

meningitidis) with use of the serum bactericidal activity (SBA) assay, and 

pneumococcal vaccines (Streptococcus pneumoniae) with the use of 

opsonophagocytic assay (OPA) will be presented as examples. 

Cara Fiore, Ph.D., Master Reviewer, Office of Vaccines Research and 

Review, CBER, US FDA 

5:45 Close of Day One 


3:45 Establishing Well-Controlled Manufacturing Processes for 

Process-Related Impurities 

Two case studies on the investigation and resolution of disulfide bond-related 

fragmentation in monoclonal antibodies: In the pursuit of gaining better process 

understanding for rapid decision-making during drug development, the need 

for analytical real-time monitoring tools becomes a critical factor in identifying 

problems before they have a serious impact on programs. Two unique case studies 

will be presented where disulfide bond-related fragmentation was observed in 

the production of monoclonal antibody therapeutics. The presentation describes 

the discovery of the fragmentation issue using rapid high-throughput analytical 

tools capable of analyzing crude cell cultures for critical attributes, the various 

theories and experiments carried out to explore root cause, as well as the solutions 

implemented to successfully eliminate the fragmentation and improve the process. 

The two case studies were approached in two very different manners, one with a 

focus on the upstream process, and one with a focus on the downstream process. 

However, in both cases, the fragmentation issue has been resolved through the 

purposeful and strategic use of available analytical technology. 

Jason Kuo, Ph.D., Sr. Associate, Process Science, Boehringer Ingelheim 

4:15 Validating a Biological Manufacturing Platform to Identify 

Variants and Control Impurities 

Gene therapies and oncolytic viruses are seeing resurgence in the industry, 

and a number of those compounds are currently in Phase III development. 

This session will focus on SAFC’s development and implementation of its 

Master Validation Plan (MVP) in support of one of its Phase III clients for 

its commercial validation project. The discussion will focus on the topic of 

process validation, product purity, and clearance of contaminants as subsets 

to the MVP. The SAFC strategy and methodology is to use validation tools 

such as a detailed process description and flow chart to identify process 

variables and critical control parameters, a risk assessment to assign relative 

values to the control parameters and product quality attributes, and a gap 

analysis between the known process and the historical data to identify areas 

where additional characterization is needed for the purposes of establishing 

an optimal design space for each unit operation of the process. 

Kevin Briggs, Head of Manufacturing, SAFC Carlsbad 

4:45 Panel Discussion: 

Biophysical Methods for the Detection of Impurities 

Moderator: 

Indresh Srivastava, Ph.D., Vice President, Product Realization and Senior, 

Project Manager, Protein Sciences Corporation 

Panelists: 

Christopher Cowan, Staff Engineer, Preclinical Manufacturing Process 

Development, Regeneron Pharmaceuticals 

Pauline M. Rudd, Professor, NIBRT Research Professor of Glycobiology, 

Dublin-Oxford Glycobiology Laboratory, NIBRT, Ireland 

Judith Shimoni, Senior Scientist / Group Leader, Protein Analytical 

Chemistry, Genentech 

Wei Xu, Ph.D., Principal Scientist, Bioprocess Development Extended, 

Characterization, Merck Research Laboratories 

5:15 Close of Day One 

“Both the organizers and the presenters did an excellent 

job – great content, variety and relevance to today’s 

industry needs…” 

– James D. Mendoza, Staff Scientist, Beckman, Coulter, Inc. 

Divide and Conquer 

It’s a fact – attendees walk away with the most value when they 

experience it with a peer – there is just too much information 

available for one person to capture it all. As a result, we are pleased 

to offer a buy 3 get 1 free offer. For more information call our group 

sales advocate at 646-895-7445. 


Tuesday, October 22, 2013 


8:00 Chairwoman’s Remarks 

Suzanne Kiani, Associate Director, Regulatory CMC, MedImmune 

Analytical Strategies for Diverse Products 

8:15 Characterization Strategies for Biologicals 

Shara M. Dellatore, Ph.D., Principal Scientist, BioProcess Extended 

Characterization, Merck & Co, Inc. 

8:45 Control Strategies for Drug Delivery Devices: Regulatory 

Considerations for Testing and Analytical Characterization 

The regulatory classification of combination product brings with it 

subsequent requirements for Risk Management, Design Controls and 

Purchasing Controls. This presentation will summarize steps that you can 

take to incorporate device centric elements to design a control strategy that 

is reflective of the combination product as a system. 

Suzanne Kiani, Associate Director, Regulatory CMC, MedImmune 

9:15 CASE STUDY/UNPUBLISHED DATA Don’t Go into the Light! 

Investigating the Changes in Color of a Therapeutic IgG1 

Antibody after Exposure to Light 

Color is an important product quality attribute to consider for release, 

stability, and comparability testing of biologics. In this study, a therapeutic 

IgG1 antibody was observed to increase in color upon exposure to light, 

indicating a light sensitivity and stability risk. Through a combination of 

chromatographic, spectrophotometric, and mass spectrometry techniques, 

photosensitizing advanced glycation endproducts (AGE’s), resulting in 

photo-induced protein oxidation and crosslinking, were implicated in the 

antibody’s light sensitivity/color change pathway. 

Galahad Deperalta, Scientist, Protein Analytical Chemistry, Genentech, Inc., 

A member of the Roche Group 



10:15 FDA Perspective Top 10 List of Analytical 

Inadequacies in IND or BLA Submissions 

Procedures to support the identity, strength, quality, purity 

and potency of drug products and drug substances are an 

important component of new product applications reviewed by 

the FDA. Inadequacies commonly encountered in these submissions involve 

procedural details, system suitability tests, representative instrumental 

outputs, types of validation characteristics, linearity in sample matrix, 

verification of “compendial” procedures, robustness of critical assay 

parameters, accuracy calculations, precision and accuracy across intended 

range and factors in intermediate precision. FDA expectations for analytical 

procedures and validations will be discussed. 

Alfred Del Grosso, Team Leader, Analytical Chemistry, 

Division of Biological Standards and Quality Control, CBER, US FDA 

11:00 Oral Poster Presentation Session 

Several poster presenters will be chosen to provide a short presentation to 

introduce their work using a single slide to the entire conference. Submit 

your poster abstract today at www.IBCLifeSciences.com/WCB for a chance 

to be selected for this opportunity. 

11:45 Technology Workshop 

New Tools and Methods for Label-Free 

Characterization of Biotherapeutic Molecules 

To address the large number of biotherapeutic molecules in development, 

biopharmaceutical companies are adopting a new generation of rapid, 

high-sensitivity analytical techniques for molecular characterization and 

bioprocess monitoring. In this seminar, we will review recent advances in 

label-free methods for biopharmaceutical molecules. Specific topics will 

include new tools for the quantitation of cell culture samples, impurity 

analysis such as residual protein A and HCP, and activity monitoring of 

molecules throughout bioprocess to quality control. 

Rashi Takkar, Marketing Application Scientist, ForteBio, 

A Division of Pall Life Sciences 



Dean Ripple, Ph.D., Leader, Bioprocess Measurements Group, 

National Institute of Standards and Technology 

Regulatory and Scientific Organization and 

Industry Perspectives on Process Variants and 

Impurity Characterization 


8:15 FDA Perspective Changing the Manufacturing Process to 

Remove Impurities and Monitoring Product Quality Using 

Relevant Lot Release Assays 

Process- and product-related impurities in therapeutic products can lead 

to adverse events. When CMC information related to the adverse events are 

available, the potential risk could be reduced by controlling the levels of the 

implicated impurities through changes in the manufacturing process and 

monitoring of the quality of the product using relevant lot release assays. 

Mikhail V. Ovanesov, Ph.D., Visiting Scientist, Principal Investigator, 

Laboratory of Hemostasis/Division of Hematology, Office of Blood 

Research and Review, CBER, US FDA 

8:45 Current Approaches for Standardization and 

Compendial Procedures 

This presentation discusses the U.S. Pharmacopeia’s efforts on developing 

recommended practices for identifying and controlling product and process 

variants and impurities during the lifecycle of a biologic product. 

Fouad Atouf, Ph.D., Director, Biologics and Biotechnology, US Pharmacopeia 

9:15 UNPUBLISHED DATA The National Institute of Standards and 

Technology (NIST) Subvisible Particle Round-Robin 

Comparison: Results and Lessons Learned 

NIST has conducted a round-robin comparison for sizing and counting 

subvisible particles from 1 µm to 25 µm, using a polydisperse polymer 

suspension that closely mimics actual protein particles. Twenty-four 

laboratories from industry, government, and academic institutions 

participated. The results give a snapshot of the level of agreement between 

different laboratories and for different particle counting instruments. 

Dean Ripple, Ph.D., Leader, Bioprocess Measurements Group, 

National Institute of Standards and Technology 


10:15 CASE STUDY/UNPUBLISHED DATA Identification and Control of 

Process Impurities and Product Related Variants in the 

Development and Manufacture of a Glycoprotein 

Process improvements in CHO cell expression of a glycoprotein involves 

bioreactor conditions that impose biophysical and biochemical pressures on 

cellular biosynthetic and biochemical pathways. Upstream and downstream 

strategies have been used to control glycan variation. An upstream goal 

is for harvested material to contain the desired product profile. However, 

product variation exists that include glycan species with less preferred 

characterization, i.e., complex heterogeneity and other CHO glycoprotein 

impurities that together can challenge the process and product profile. 

This presentation will discuss examples of CHO glycoprotein variants and 

impurities encountered in the development and manufacturing process. 

Kirk J. Leister, Ph.D., Director of New Technology, 

Bristol Myers Squibb Company 

12:15 Networking Luncheon and Exhibit/Poster Viewing 


Tuesday, October 22, 2013 (continued) 




Characterization and Comparability of Vaccines 

1:45 FDA Perspective Regulatory Considerations in the Safety 

Assessment of Vaccine Adjuvants and Adjuvanted Vaccines 

This presentation provides background information on vaccine adjuvants 

and adjuvanted preventive and therapeutic vaccines for infectious disease 

indications; present an overview of vaccine adjuvants under investigation 

and in U.S.-licensed vaccines; and delineates the regulatory considerations 

for the nonclinical and clinical safety evaluation of investigational vaccines 

containing novel adjuvants. 

Carmen M. Collazo-Custodio, Ph.D., Microbiologist, Primary Reviewer, 

Division of Vaccines and Related Product Applications, CBER, US FDA 

2:15 CASE STUDY/UNPUBLISHED DATA Analytical Characterization 

Strategies and Challenges of Protein Vaccine Products 

An enhanced approach to product development requires building product 

understanding throughout the development lifecycle. The focus of this 

presentation is on analytical characterization strategies and challenges 

during protein vaccine development. Case studies are provided to elucidate 

the value of characterization studies and orthogonal tools for virus-like 

particle and protein nanoparticle vaccines. 


2:45 Validation of a Multiplexed Serological Method for the 

Potency Testing of Multicomponent Vaccines 

A serological potency assay on Guinea pigs is now referenced in the European 

Pharmacopoeia for DTacP vaccine. This alternative assay will reduce the 

number of animals due to the ability to use the same animals for multiple 

antigens. We developed a common immunogenicity assay on guinea pigs 

with a multiplex antibody detection method. The current potency assay was 

compared to the new potency assay. Data supporting the replacement of the 

current potency by the new alternative assay is presented. 

Martine Chabaud-Riou, Scientist, Analytical R&D, Sanofi Pasteur, France 


Why Do Attendees Return to 


Year after Year? 

Don’t Take Our Word for It – Read These 

Rave Reviews from the 2012 Event 

“Well organized and balanced conference” 

– Parag Goyal, Principal Scientist, Dr. Reddy’s Laboratories 

“It’s a great conference in the biologics arena” 

– Shenjiang Yu, Associate Director, Merck & Co. 

“Even with obstacles from Mother Nature (namely 

Hurricane Sandy), the conference went on and I had a 

wonderful experience attending” 

– Wing-Yee Fu, Associate Scientist, Momenta Pharmaceuticals 

“…Very relevant with current events and trends. It 

provided a good arena to network and share ideas and 

best practices.” 

– John Alvino, Manager, MedImmune 


Aggregation and Subvisible Particles 


10:45 Practical Considerations to Characterize and 

Control Protein Aggregates During the 

Development Cycle and Commercialization 

with a Focus on the Visible Size Range 

The focus will be on the value of putting in place a number of proactive 

steps that anticipate the need to address aggregation within the setting of 

manufacturing and setting specifications and QbD expectations. 

Erwin Freund, Ph.D. Scientific Executive Director, Drug Product 

Engineering, Amgen Inc. 

11:15 UNPUBLISHED DATA Subvisible Particles and Associated Impact 

on Virus-Retentive Filter Performance 

To ensure safety of antibody drug products, regulatory agencies require 

steps to ensure the removal of endogenous and adventitious viruses. 

The implementation of a virus-retentive filter in the purification process 

is intended to provide robust, size-based virus reduction orthogonal to 

chromatographic steps. Virus-retentive filters are vulnerable to premature 

fouling by impurities, such as subvisible particle (SVP) species, present in 

some feed streams. This study aims to characterize the direct impact SVPs 

have on the virus-retentive filter performance and explore methodologies to 

develop robust processes for commercial scale production. 

Christopher Cowan, Ph.D., Staff Engineer, Preclinical Manufacturing 

Process Development, Regeneron Pharmaceuticals 

11:45 Presentation Sponsorship Opportunity 

For more information on sponsored opportunities to present an exciting 

technology or application in this conference session, please contact Jennifer 

Thebodo at jthebodo@ibcusa.com 

12:15 Networking Luncheon and Exhibit/Poster Viewing 


Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories 

1:45 UNPUBLISHED DATA Understanding the Response of Particle 

Detection Instruments to Non-Spherical Particles 

While most particle imaging/analysis instruments work well with spherical 

particles (e.g., polystyrene beads), actual particles (such as aggregated protein) 

are often irregular and elongated. We have fabricated monodisperse polymer 

particles of various shapes to understand the response of particle counters to 

non-spherical particles. Detection technology considered includes: the human eye, 

electrical sensing zone (Coulter counter), light obscuration, and flow imaging. 

Michael Carrier, Bioprocess Measurements Group, National Institute of 

Standards and Technology 

2:15 CASE STUDY Understanding and Implementing Effective 

Extractable and Leachable Programs 

Impurities resulting from contact surfaces in the manufacturing process or in the 

final container closure system are referred to as leachables. These compounds can 

have a significant impact on the drug product’s safety and efficacy. Understanding 

the potential sources of these compounds and the analytical tools to detect 

them can be vital to a development program. Designing and implementing an 

extractables and leachables program can save significant time/cost in development 

and potentially avoid pitfalls, which may increase time to market. 

Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories 

2:45 Analysis of Host-Cell Proteins in Biotherapeutic Proteins 

by Comprehensive Online Two-Dimensional Liquid 

Chromatography/Mass Spectrometry 

Residual host cell proteins (HCPs) are ppm-level contaminants in 

biotherapeutics that may elicit an unpredictable immune response and need 

to be monitored. The identification and quantitation of low-level HCPs in 

biopharmaceuticals using two-dimensional chromatography and dataindependent 

mass spectrometry will be discussed. The incorporation of ion 

mobility to resolve peptides in multiple dimensions is demonstrated. 

Weibin Chen, Ph.D., Senior Manager, Scientific Operations, Late Stage 

Development, PLS Business Operations, Waters Corp. 


8 www.IBCLifeSciences.com/WCB Variant and www.IBCLifeSciences.com/Variants 

Impurity Challenges in Vaccine

Tuesday, October 22, 2013 (continued) 


Comparability Strategies for Biotechnology Products 

3:45 Similarity and Comparability: What’s in and What’s out? 

Biosimilar and novel protein products have overlapping but distinct criteria 

for successful development, licensure, and post-approval changes. This talk 

will describe the interactions between the different pathways for developing 

and licensing a quality protein product, examining high level issues as well as 

the details that form the core of regulatory decision-making. 

Emily Shacter, Ph.D. Consultant, ThinkFDA, LLC; 

Former Chief, Laboratory of Biochemistry, CDER, US FDA 

4:15 Health Canada Perspective CASE STUDY High Resolution NMR 

Fingerprinting the Higher Order Structure of Biosimilars: 

A Comparability Tool 

In this paper, we show through a case study that a simple NMR method 

can provide detailed information on the higher order structure of protein 

therapeutics. The NMR fingerprint assay applied to Filgrastim provided 

residue specific information of the structure of the active ingredient 

of a product. In addition to current methods, the ability to assess the 

conformation with a high degree of resolution can greatly facilitate the 

comparability exercise. 

Yves Aubin, Ph.D., Research Scientist, Centre for Vaccine Evaluation, 

Biologics and Genetic Therapies Directorate, Health Canada 

4:45 UNPUBLISHED DATA High-resolution NMR Analysis of Protein 

Therapeutics: An Inter-laboratory Round Robin Study 

High-resolution NMR methods can yield spectral ‘fingerprints’ related to 

the structure of the bioactive form(s) of protein therapeutics at atomic 

resolution. This presentation reports on an inter-laboratory study aimed 

at establishing NMR methods for obtaining spectral ‘fingerprints’ of 

protein therapeutics and how these ‘fingerprints’ can be used to establish 

consistency in drug manufacturing and for comparing a biosimilar to an 

innovator reference product. 

John P. Marino, Ph.D., Leader, Biomolecular Structure & Function Group, 

IBBR-NIST 

5:15 CASE STUDY/UNPUBLISHED DATA Comparability Assessments Linking 

Clinical Trial Batches to Commercial Manufacturing 

Changes in scale, process chemistry or manufacturing site may suggest a 

need for a comparability assessment in order to link the manufacture of 

pivotal study materials to the proposed commercial manufacturing process. 

This presentation presents a case study around the risk assessment and 

Critical Quality Attributes for changes in drug substance manufacturing. 

Alan V. Klotz, Ph.D., Advisor, Research and Development, 

Elanco Animal Health, a division of Eli Lilly & Co. 

5:45 Close of Day Two 


Development and Production 

3:45 CASE STUDY/UNPUBLISHED DATA Control of Process-Related 

Impurities for a Recombinant Seasonal Influenza Vaccine 

Flublok influenza received FDA approval for the prevention of influenza in 

adults aged 18 to 49 in January 2013, making this product the first licensed 

recombinant influenza vaccine. Our strategy regarding control of process 

related impurities and maintaining product quality for a recombinant 

product whose composition changes annually will be discussed. 

Penny L. Post, Ph.D., Vice President, Regulatory, Protein Sciences Corporation 

4:15 Analytical Considerations for Isolating Variants 

and Impurities 

This talk discusses the need for developing a separate set of analytical assays 

for in-process testing, product release and product characterization; criteria 

for selecting which assays can be used for which application; and examples 

from vaccines produced in different systems. 

Indresh Srivastava, Ph.D., Vice President, Product Realization and Senior 

Project Manager, Protein Sciences Corporation 

4:45 CASE STUDY/UNPUBLISHED DATA Removal of Product Related 

Impurities for a Recombinant Malaria Vaccine 

The development of highly-purified malaria vaccines remains a challenge. 

Using the Pfenex Pseudomonas fluorescens expression system, a 

recombinant vaccine was produced to support Phase I clinical trials. The 

molecule was shown to be prone to rapid multimerization and N-terminal 

degradation during recovery and purification. Careful attention to the 

expression parameters and recovery of the vaccine protein from the 

biomass were an essential components of the manufacturing process. The 

development of a robust, orthogonal purification process resulted in a highyield, 

GMP-compliant process that generated high-quality protein that was 

shown to be potent in animal models. 

Steven L. Giardina, Ph.D., Director, Process Analytics/Quality Control, 

Biopharmaceutical Development Program, SAIC-Frederick, Inc. 

5:15 Late-Breaking Presentation 

5:45 Close of Day Two 

Reserve Your Exhibit Booth or Sponsorship Today 

The exhibit hall for this conference has been growing annually as event attendance has increased. Reserve your booth today or 

contact us to find out about opportunities to promote your product or service via sponsorship or other marketing programs. 

For more information, contact: Jennifer Thebodo: Tel: 508-614-1672; E-mail: jthebodo@ibcusa.com 

Confirmed Exhibitors (as of July 19, 2013): 


Wednesday, October 23, 2013 • Plenary Session 

8:30 Chairwoman’s Remarks 


Host Cell Protein and Host Cell DNA Characterization 

and Control 

8:15 FDA Perspective Regulatory Perspectives on 

Host Cell Protein Characterization and Control 

Laurie Graham, Acting Team Leader, Product Quality/CMC, Division of 

Monoclonal Antibodies, CDER US FDA 

8:45 UNPUBLISHED DATA New USP Chapters for Measurement 

of Residual Host Cell Protein and DNA Impurities in 

Biotherapeutics 

USP will soon propose a new test chapter Residual DNA Testing 

containing a validated method with two new Reference Standards for CHO 

and E. coli genomic DNA. Another new chapter contains best practices for 

development, validation, and use of residual HCP testing methods. Details 

of the chapters are presented. 

Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics & 

Biotechnology, US Pharmacopeia 


The Devil in the Detail – 

HCP Assay Performance by Design 

Although immunoassays for HCP determination are well established in QC 

applications, there are some inevitable risk factors (antigen, animals etc.) 

associated with this approach. This presentation will highlight challenging case 

studies from more than twenty years of experience in HCP assay development. 

Critical parameters and quality attributes along the assay development process 

will be examined along with newly emerging technologies. 

Michael Hantman, Ph.D., Associate Director Methods Development, 

Charles River 

9:45 Impact of Host Cell Proteins on GMP Testing and Process 

Characterization/Process Validation 

As the pace quickens to move molecules through the pipeline to market, the 

quality and integrity of drug products must be maintained. The accurate 

quantification and identification of residual host cell proteins in GMP and 

PC/PV materials provide multiple challenges to today’s testing paradigm. 

Lori O’Connell, Manager, Analytical Operations, Genentech, Inc., 

A member of the Roche Group 


Use of QPCR and DNA Sequencing Tools 

to Ensure Product Quality and Safety 

Quantitative PCR (Q-PCR) and DNA sequencing are tools that enable rapid, 

sensitive and precise quantitation, detection and identification of critical cellular 

and process impurities in cell culture manufacturing and product purification. 

Additionally, these tools can be utilized in development and characterization 

of production cell lines and in routine monitoring of cell line stability. In 

this presentation, the applications of these technologies and present data 

demonstrating the performance of assays for impurity assessment, cell line 

characterization, contaminant detection and identification are reviewed. 

Wesley Straub, Ph.D., Senior Product Manager, Bioproduction, 

Life Technologies 

10:45 Networking Refreshment Break 

Characterization of Degradation Pathways 

11:15 Utilization of Forced Degradation Data in Product 

Regulatory Filings 


11:45 CASE STUDY Predict Protein Thermal Aggregation Kinetics by 

Differential Scanning Fluorimetry 

Differential scanning fluorimetry (DSF) is an emerging technique to study 

protein thermal unfolding and has a great potential to be employed as both 

a protein characterization tool and a first-pass high-throughput screening 

(HTS) assay in formulation screening and development. In a case study, 

we demonstrate how DSF together with analytical ultracentrifugation 

(AUC) can predict protein concentration dependent thermal aggregation 

kinetics. In another case study, we show the importance of establishing 

an appropriate correlation upfront in understanding different aggregation 

behaviors at high concentration for different proteins. 

Shuai “Sunny” Shi, Ph.D., Senior Scientist, Sterile Product Development, Merck 

12:15 CASE STUDY/UNPUBLISHED DATA Assessment of Potential Protein 

Degradation Sites in the CDR of Recombinant Antibodies 

Degradation of proteins by asparagine (Asn) deamidation and methionine 

(Met) oxidation can impact in vivo biological functions and in vitro stability of 

therapeutic antibodies (mAbs). In the present study, an approach employing 

stress conditions (elevated temperatures, pH, and oxidizing agents) and 

proteolytic peptide mapping combined with quantitative LC-MS for the 

induction, identification and quantification of Asn deamidation and Met 

oxidation was developed. This test system allowed us to identify a light chain 

Asn and heavy chain Met, both located in the CDR 3, as potential chemical 

degradation sites in a recombinant IgG1. 

Markus Haberger, Manager Development Characterization, 

Roche Diagnostics GmbH, Germany 

12:45 Lunch on your own 

Biophysical and Structural Characterization Strategies 

2:00 FDA Perspective Particulate Testing and Specifications for 

Subvisible and Visible Particulates 

Particulate matter in protein therapeutics may originate from various sources 

and it may affect the safety and efficacy of the products. Limiting the amount of 

particulates and ensuring product consistency through adequate testing reduces 

the risks related to their presence. Recent advances in understanding the safety 

of particulate matter with focus on protein aggregates, testing methodologies 

and trends in setting standards will be discussed. 

Ewa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, Division of 

Hematology, CBER, US FDA 

2:30 Development of Compendial Analytical Procedures for 

N-Glycan Analysis 

The United States Pharmacopeia is developing a new General Chapter to provide 

qualitative analysis of glycosylation through profiling of released N-linked 

oligosaccharides (or N-glycans). This chapter consists of validated analytical 

procedures and performance criteria. Furthermore, four reference standards have 

been proposed to assess the system suitability for the analytical procedures. 

Edith Chang, Ph.D., Reference Standards Scientist, Biologics and 

Biotechnology, US Pharmacopeia 

3:00 NMAP: A Novel Approach to Understanding Molecular 

Structure Using Native Peptide Mapping 

Spectroscopic techniques such as circular dichroism and intrinsic fluorescence are 

commonly used to assess the higher order structure analysis of proteins. However, 

detailed molecular understanding is challenging as these techniques provide structural 

ensemble data. The use of orthogonal methods is essential to understand complex 

biological molecules. An orthogonal method, Native Peptide Mapping (NMap), 

was developed on the basis of a traditional peptide mapping in order to address 

local structural understanding. The evaluation of the potential of NMap to generate 

tertiary structure related data, as well the correlation of the results with traditional 

spectroscopic techniques using a drug substance monoclonal antibody is discussed 

in this presentation. The proposed use of NMap would include characterization 

understanding and application for comparability data and submissions. 

John O’Hara, Ph.D., Director, Characterization and Method Development, 

Analytical Sciences, Biologicals, UCB, United Kingdom 

3:30 Panel Discussion: 

Sensitivity of Methods to Detect Variants and Impurities 

• Why is accurate validation and system suitability of LOQ critical for variant 

and impurity assays? 

• How do you bridge old methods to new methods for variants and impurities? 

• What should you do if more sensitive methods cause increased detection of 

small amounts of impurities/variants? 

• How does a biosimilar product assess comparability to the variants and 

impurities of the innovator product? 

Moderator: 


Panelists: 

Ewa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, 

Division of Hematology, CBER, US FDA 

Mikhail V. Ovanesov, Ph.D., Visiting Scientist, Principal Investigator, Laboratory of 

Hemostasis / Division of Hematology / Office of Blood Research and Review, 

CBER, US FDA 

Anton V. Manuilov, Ph.D., Sr. Scientist II, Protein Analytics, 


Judy Shimoni, Ph.D., Senior Scientist, PTDU - Protein Analytical Chemistry, 

Genentech, Inc. 

Kirk J. Leister, Ph.D., Director of New Technology, Bristol Myers Squibb Company 

4:00 Close of Conference 


3EASY WAYS 

TO REGISTER: 

@ 

CALL 

EMAIL 

800.390.4078 or reg@ibcusa.com 

+1.941.554.3500 

WEB 


Prioriity Code: B13193PDFWDL 

On or before 

October 11, 2013 

Standard Rate 

After October 11, 2013 

GROUP RATE* 

Register 3, 4th is Free 

Industry Fees $2,099 $2,299 $1,724 per person 

Academic/Government Fees $1,099 $1,299 $974 per person 

*Register 3 from one company at the standard rate at the same time, and the 4th person is free. Cannot be combined with other offers. 

Take an Active Role in the Conference and Present a Poster – Deadline to submit is September 20, 2013 

For poster guidelines and to submit a poster abstract, log on to www.IBCLifeSciences.com/WCB or www.IBCLifeSciences.com/Variants. All poster presenters 

must be registered conference attendees. Only one poster presentation is allowed per registered attendee/author. The fee to present a poster in addition to 

your conference registration is: Vendors/Supplier*: $300 Pharma/Biotech: $100 Academic/Government: FREE 

* Vendor rate is for exhibiting/sponsoring companies and/or posters that upon review are of commercial/product focus. 

Ways to Save on Your Conference Registration 

Register Early: 

The earlier you register the lower the fee and the more you will save! 

Send a group of 3 and the 4th goes FREE! 

It’s a fact – attendees walk away with the most value when they experience 

it with a peer – there is just too much information available for one person 

to capture it all. As a result, we are pleased to offer a 4th free registration 

when you register 3 people at the standard rate. For more information call 

our group sales advocate at 646-895-7445. 

Academic and Government Special Rates 

Full-time employees of a government organization, universities and 

university-affiliated hospitals are eligible to take advantage of over a 40% 

savings off industry rates. 

Your Colleague Is Speaking at this Conference 

If you are from a company that is already sending another person to 

present at this conference, you qualify for a 20% discount off the standard 

rate. Contact your colleague who is speaking for their discount code. 

Your Company Is Exhibiting or Sponsoring this Event 

If you are from a company that is exhibiting or sponsoring this event, you 

qualify for a 20% discount off the standard rate. Contact your marketing 

person for the discount code. 

Featured Publication: 

Media Partners: 

Venue: 

L’Enfant Plaza Hotel 

480 L’Enfant Plaza, SW 

Washington, DC 20024 

Tel: 202-484-1000 

Fax: 202-646-4456 

Special Conference 

Rate $189 Per Night 

Plus Tax 

Discounted Hotel Reservations: Please call 1-800-635-5065 to reserve your 

room or reserve online at www.lenfantplazahotel.com using Code IBC13. Be 

sure to identify yourself as a participant at IBC’s Well Characterized Biologicals 

or Product and Process Variants & Impurities conference. Group rate valid until 

September 23, 2013 or sold out. Please Note: All reservations must be guaranteed 

by a valid, major credit card at the time of reservation. A one night nonrefundable 

deposit is required to secure a room. 

Additional Registration Information 

For onsite registrations, please add $100. 

Program content and speakers subject to change. Conference badges are nontransferable 

and lost badges will not be replaced without payment of the full 

conference registration fee. 

Please note that payment is required in advance of the conference. Please make 

check(s) (in U.S. funds drawn on a U.S. bank) payable to IBC Life Sciences and 

attach to the registration form. Confirmation of your booking will be sent. Should 

you elect to pay by MasterCard, Visa or American Express, please send your credit 

card number, expiration date, name as it appears on card and signature along 

with the registration form. 

Registration Substitutions/Cancellations: If you need to make any changes or 

have any questions, please feel free to contact IBC’s customer service team via 

email at reg@ibcusa.com. Cancellations must be in writing and must be received 

by IBC prior to 10 business days before the start of the event. Upon receipt of 

a timely cancellation notice, IBC will issue a credit voucher for the full amount 

of your payment, which may be applied towards registration fees at any future 

IBC event held within 6 months after issuance (the “Expiration Date”). All credit 

vouchers shall automatically expire on the Expiration Date and shall thereupon 

become void. In lieu of issuance of a credit voucher, at your request, IBC will issue 

a refund less a $595 processing fee per registration. Registrants are advised that 

no credit vouchers or refunds will be issued for cancellations received 10 business 

days or less prior to start of the event, including cancellations due to weather or 

other causes beyond the Registrant’s control. IBC therefore recommends that 

registrants allow for unexpected delays in making travel plans. Substitutions are 

welcome at any time. If for any reason IBC decides to cancel this conference, 

IBC accepts no responsibility for covering airfare, hotel or other costs incurred by 

registrants, including attendees, sponsors, speakers and guests. 

SPECIAL NEEDS: If you have a disability or special dietary needs, please let us know 

in order that we may address your special needs for your attendance at this 

event.Please send your special needs via email to custserv@ibcusa.com 







Access Any Session at These Co-located Events for One Price 

Hear First Hand and Interact with 

8 FDA/Health Canada Speakers 

Top 10 List of Analytical Inadequacies 

Alfred Del Grosso, Team Leader, FDA 

Perspectives on Host Cell Proteins 

Laurie Graham, Acting Team Leader, FDA 

Update on the US Biosimilars Program 

Jeffrey C. Baker, Ph.D., Deputy Director, FDA 

Serologic Assays in Vaccine Development 

Cara Fiore, Ph.D., Master Reviewer, FDA 

Vaccine Adjuvants and Adjuvanted Vaccines 

Carmen M. Collazo-Custodio, Ph.D., Primary 

Reviewer, FDA 

NMR Fingerprinting Higher Order Structure 

Yves Aubin, Ph.D., Research Scientist, Health Canada 

Particulate Testing and Specifications 

Ewa Marszal, Ph.D., Chemist, FDA 

Impurities and Monitoring Product Quality 

Mikhail V. Ovanesov, Ph.D., Visiting Scientist, FDA 

Plus New Guidelines from 

3 US Pharmacopeia Presenters 

“A conference with REAL information 

that is readily applicable to real issues 

with biologicals” 

– Sheila Magil, Senior Consultant, 

Bioprocess Technology Consultants 

The Industry’s Leading Case Study-Driven Conferences 

to Help You Characterize Biological Products and 

Identify/Control Variants & Impurities 

See Inside! 19 Case Studies 

20 Unpublished Data Presentations 


Case Studies, CMC Strategies and Regulatory 

Perspectives on Protein Characterization and 

Product Comparability for Biotechnology Products 

and Biosimilars throughout the Product Lifecycle 



Identification and Effective Control of 

Variants and Impurities for Optimal 

Processing and Product Quality 


www.IBCLifeSciences.com/Variants 

Avoid Common Pitfalls in Analytical/CMC Studies 

Case Studies and Lessons Learned from: Amgen, Genentech, 

ImmunoGen, Oncomed, AbbVie, Sandoz, Biogen Idec, 

Millenium/Takeda, Merck, MedImmune, Novavax, Sanofi Pasteur 

Immediately Apply Leading Variant and 

Impurity Control and Mitigation Strategies 

Exclusive Insight from: AbbVie, Amgen, BMS, Boehringer 

Ingelheim, FDA, Genentech, Genzyme, Merck, NIST, NIBRT, 

Pfizer, Protein Sciences Corp., Regeneron, University of Kent

Product and Process Variants & Impurities

Create successful ePaper yourself

Delete template?

Save as template?