Broadening the Custom Synthesis Technolgoy Portfolio - Almac

Broadening the Custom
Synthesis Technolgoy Portfolio
Custom synthesis and service R&D company, CSS, has expanded its technology
offerings in the past few years to include peptides, oligonucleotides and proteins,
chemo- and biocatalytic services, plus high-potency APIs and cytotoxics. Stephen Barr
explains how the company has changed and outlines its plans for the future.
CSS has developed its technologies and business through organic growth,
acquisition and partnership. The main developments and investments in CSS
since its establishment in 1992 (see Box below) include the formation of
QuChem in 1992, the formation of SynGal in 1997 and the merger of the two
companies in 2000 to form CSS. In 2002 the company acquired ABC
Laboratories, a specialist in bio-analysis. In 2004, it acquired a majority
interest in Albachem, thus adding solid phase peptide synthesis to its
technology portfolio. Later that year CSS expanded its fine chemical facilities
with the addition of new laboratories, a kilo lab and cytotoxic suites. In 2004
the company established an alliance with BioFocus to provide the chemistry
required to synthesise chemical libraries for drug discovery and earlier this
year broadened its offering through establishing The Chiral Consortium,
providing access to bio- and chemocatalysis technologies.
Strategic acquisitions enhance technology offerings
Using the acquisition of Albachem as an example, Dr Stephen Barr, Managing
Director of CSS, explains the thinking behind the company’s recent
acquisitions:
“The acquisition of Albachem is an excellent fit with our strategy. Albachem,
now named CSS-Albachem, possesses leading technology in an important
niche market, that of peptide and protein synthesis. We are augmenting this
technology through selective R&D programmes and broadening its application
through investment in GMP assets. The strategic acquisition will strengthen
the CSS service offering to global clients and further strengthen the
company’s provision of niche speciality areas to the pharmaceutical industry.
This acquisition further enhances CSS’s market differentiation through
provision of specialist high-technology services and builds upon the chemistry
expertise within the company as well as furthering our position at the interface
between chemistry and biology.”
Albachem was founded by Professor R. Ramage in 1994, within the
University of Edinburgh, and moved to new facilities near Edinburgh in 2002.
The company provides advanced peptide chemistry in biotechnology and has
developed superior and unique methods for the production of small protein
structures that cannot be made by biological recombinant techniques.
Barr says that there was a similar rationale behind the establishment of The
Chiral Consortium with ChiralQuest and IEP:
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Broadening the Custom Synthesis Technolgoy Portfolio
“We are committed to providing our customers with access to world-leading
chiral technology that works now. We also believe it is important to offer
impartial technology selection, transparent IP arrangements and the ability to
have products manufactured wherever our customers wish. The Chiral
Consortium deal structure and technology capability allow us to do that,” he
says.
The new partnerships enable CSS to provide custom chiral synthesis on a
global basis, with the company solving its customers’ synthetic problems
using tools provided by Chiral Quest and IEP. Manufacturing is carried out at
the CSS cGMP facility in Craigavon, Northern Ireland. The company can also
provide versatile chiral products in collaboration with each technology partner,
taking advantage of manufacturing capacity. “The entry into the chiral market
is an important development for CSS as it aims to become a major force in
the provision of chiral products worldwide,” says Barr.
The move underpins CSS’s determination to combine its own innovation with
that of leading technology providers. Chiral Quest, a provider of chiral chemocatalytic
technology based at Monmouth Junction, New Jersey, is a subsidiary
of VioQuest Pharmaceuticals, a publicly traded US company. Its technology
provides cost-efficient access to a broad range of chiral amines, amino acids,
acids and alcohols. IEP, based in Wiesbaden, Germany, has expertise in
biocatalytic reduction technology, whch has been proven at multi-tonne scale
and provides access to a diverse range of chiral alcohols, diols and
epoxides. CSS also sees opportunities for more companies to join the
consortium.
MEET THE MANAGING DIRECTOR
CSS’s Managing Director, Dr Stephen Barr, joined QuChem Limited in 1994 as a senior
chemist after obtaining a BSc First Class Honours Degree in Biological Chemistry from
the University of Ulster and a PhD in Organic Chemistry from Queen’s University,
Belfast. He also completed a Postdoctoral Fellowship at Queen’s. In 1997, he became a
Technical Manager at QuChem, and in 2000 was made Vice President of CSS. He was
appointed as the company’s Managing Director in 2001.
Differentiation through combined technologies
The company’s strategy is to differentiate itself from global competition
through the provision of products and services that are individually attractive
and compelling in combination, says Barr:
“Our tactics towards that end are internal investment, acquisition and
partnership. Throughout we are guided by maximising the value we can
create for our customers, without burdening them with undue costs. This
approach is driving our competitiveness and is resulting in excellent sales
growth. We are principally looking at technology-based partnerships at the
moment. The key driver for us is to partner with the best companies now and
in the future. However, acquisition is not ruled out,” he says.
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Broadening the Custom Synthesis Technolgoy Portfolio
Barr emphasises ‘connectivity of service’ as a major factor in enabling the
company to differentiate itself from the competition:
“The connectivity of our service is a major differentiator and one that we will
increasingly exploit. Uniquely among our competitors, we have both the skills
to provide winning manufacturing and the intent to site these solutions
wherever our customers wish. As a result of our business strategies we have
grown sales by over 40 per cent in the past year, and we expect ongoing
growth to be in the 20-30 per cent range. We expect to grow our presence in
the biotech sector substantially.”
Expanded facilities and services
CSS has already significantly augmented its specialist unit for the
manufacture of peptides, oligonucleotides and proteins, as well as its potent
manufacturing facilities. Following the integration of the peptide and protein
business of Albachem, the company’s strategy is to accelerate the pace of
scientific discovery and development of biopharmaceutical drugs. A number of
pharmaceutical and biotechnology companies already benefit from the
company’s proprietary synthesis and purification techniques in this area,
allowing easy access to chemical synthesis for long proteins (up to 170 amino
acids) with the speed and purity only previously possible in the synthesis of
much smaller peptides. A major consequence of the integration of the
technology into CSS is the company’s ability to carry out small-scale cGMP
manufacture of peptides, oligonucleotides and proteins.
CSS also announced in December of last year the expansion of its potent and
cytotoxic manufacturing and micronisation capabilities following the
commissioning of and commencement of production from new facilities at its
Craigavon, Northern Ireland site. The company now offers manufacture of
highly active pharmaceutical ingredients (HAPIs), cytotoxics and cytotoxic
conjugates from these facilities.
“Many companies in our sector are struggling to reconcile a high-cost asset
base with meeting the challenge of global, low-cost competition. Closure and
consolidation is inevitable. The companies that prosper will possess excellent
technology and the ability to transfer manufacturing solutions – anywhere, and
this is the thinking behind our successful business strategy,” says Barr.
FURTHER INFORMATION
CSS, Chemical Synthesis Services
Seagoe Industrial Estate
Craigavon BT63 5UA
United Kingdom
Tel: +44 28 3833 2200
Fax: +44 28 3833 2299
Internet Links: Email: info@css-almac.com Web: www.css-almac.com
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Broadening the Custom Synthesis Technolgoy Portfolio
ABOUT CSS AND ALMAC SCIENCES
Part of the Almac Sciences group, CSS is a leading provider of chemistry and
analytical services to the pharmaceutical industry and operates on three sites within
Northern Ireland: Craigavon, Coleraine and Belfast.
Almac Sciences and its affiliated companies (CSS, CTS, ICTI, PDMS) provide
pharmaceutical services across drug discovery, manufacture of APIs, clinical trials and
drug product manufacture. Its operations are based in Pennsylvania, North Carolina
and California in the USA, with UK operations in London and Northern Ireland.
CSS: ACQUISITIONS, INVESTMENTS AND DEVELOPMENTS SINCE 1992
The most significant developments in the history of CSS are as follows:
• 1992 - Formation of QuChem, providing R&D to kilo-scale fine chemicals (noncGMP
operation)
• 1997 - Formation of SynGal, a division of Galen Holdings PLC, providing process
development, cGMP manufacture, micronisation and analytical services
• 2000 - Merger of QuChem and SynGal to form CSS
• January 2002 - Privatisation of CSS through acquisition from Galen Holdings PLC
by Dr Allen McClay, founder of Galen Holdings
• October 2002 - Acquisition of ABC Laboratories, specialising in bio-analysis
• September 2003 - Investment of $40 million in new facilities including laboratories,
a kilo lab and cytotoxic suites
• March 2004 - Majority shareholding in Albachem - specialist in solid phase peptide
synthesis up to 170
• April 2004 - Alliance with BioFocus plc, providing chemistry expertise for the
synthesis of focused libraries
• January 2005 - Formation of The Chiral Consortium, providing access to leading
bio- and chemocatalysis technologies
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