Broadening the Custom Synthesis Technolgoy Portfolio

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					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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