LabAutomation 2006 - SLAS

TP85
Evan F. Cromwell
Blueshift Biotechnologies
Sunnyvale, California
ecromwell@blueshiftbiotech.com
LabAutomation2006
Co-Author(s)
Steven C. Miller, Blueshift Biotechnologies
Paul B. Comita, Chris B. Shumate, Paul Tam
Development and Use of IsoCyteTM-HTS: A High Throughput Platform for Single Cell
and Clonal Analysis
Hybridoma technology traditionally has involved a series of steps, here broadly categorized as cell fusion, the plating of master cell
cultures, and antibody screening. The ultimate goal is to identify a single hybridoma cell producing a monoclonal antibody with a desired
specificity or function. Until recently, hybridoma producing laboratories have pursued a labor-intensive and time consuming serial path of
hybridoma culturing and limiting dilution cloning to achieve clonality. Blueshift Biotechnologies has developed a powerful new screening
platform, the IsoCyteTM, as a high throughput platform for multiparametric screening of cells in multi-well plates using laser scatter and
fluorescence measurements. Here we report on the development and use of the IsoCyteTM-HTS for automated screening of hybridoma
and transfectoma cultures for antibody production. The automated instrument acquires a laser scatter and/or fluorescence image of each
well allowing true full well or plate inspection at throughputs of 120 seconds/plate, and at a resolution of 10 microns regardless of the
plate well density. The platform addresses the need to i) detect wells containing a single fluorophore-labeled cell, ii) monitor the growth of
cultures, and iii) verify cell clonality in an automated fashion. The IsoCyteTM-HTS enables a high degree of process control and automated
data processing important for therapeutic discovery and development environments.
TP86
Peter Greenhalgh
Astech Projects ltd
Runcorn, Cheshire, United Kingdom
peter.greenhalgh@astechprojects.co.uk
Co-Author
Anthony Moran
Next Generation Automated Emitted Dose Testing System
Consistent dose delivery is one of the most important performance requirements for inhalation drug products to ensure that such products
deliver a predictable and reproducible therapeutic dose throughout the lifetime and expected patient use of the delivery device. One
possible solution to manage the extent of testing is by automation of device testing. At the same time however, regulatory pressures and
CFR21 part11 compliance issues render the development of such automation systems complex.
Inhalers are becoming ever more sophisticated with the inclusion of advanced design features such as lid opening mechanisms, dose
counters, firing mechanisms and breath actuation. These modifications in themselves often add complexity in, for example, device handling
and firing and thus, device performance checks and extensive system suitability checks are required before use or firing of each dose. The
barriers for entry and development of such automation systems is often prohibitive.
This paper describes the development of a next generation, highly flexible, high throughput Automated Emitted Dose system. One of the
main features of the system is the unique modular library approach and scalability to both design and system build. System advances
include capacity to fire up to 150-200 emitted dose collections per day, dose parameter control, dose indexing, waste fire collection and
bar code tracking. Device performance checks such as air-flow resistance, leak testing and check weighing modules will be described.
Sample collection includes an innovative emitted dose collection chamber that can recover drug product in as little as 25ml solvent with
rinsing and a fully automated HPLC vial collection module with capacity for up to 400 HPLC vial collections.
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