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Peptides & Proteins Broadening the peptides manufacturing portfolio Lukas Utiger, Head of the Business Sector Exclusive Synthesis at Lonza, explains the strategic thinking behind the company’s recent acquisition of the Bioproducts manufacturing division of UCB and how the company is moving forward in developing its business in the custom peptides manufacturing sector. L onza has made a big impact in the peptides manufacturing sector following its recent acquisition of UCB-Bioproducts. Lonza acquired UCB’s peptide manufacturing division for €120 million. The division, which has about 300 employees, is located in Braine-l’Alleud, near Belgium, Brussels, and the site now operates as ‘Lonza-Braine’. “By uniting the two peptide businesses, Lonza has become the leading and sole contract manufacturer with a historically successful track record of providing APIs from any of the three peptide technologies, solid phase peptide synthesis, liquid phase peptide synthesis, and recombinant technology,” says Lukas Utiger, Head of the Business Sector Exclusive Synthesis at Lonza. “Lonza is now capable of rapidly providing the market with additional capacity. This acquisition provides us with a site having global reach in peptides, and world-leading process development and production expertise to serve its customer base. Lonza-Braine perfectly complements our other sites in Visp, Switzerland, Riverside Conshohocken in the USA, and Kourim in the Czech Republic, thus significantly elevating the level of our customers’ sourcing security.” Custom chemical products Lonza generated sales of SFr2.52 billion in 2005. The company operates 22 production and R&D sites around the world providing custom manufacture of chemical intermediates, active ingredients and biopharmaceuticals for the pharmaceutical and agrochemical industries. On the basis of its organic chemical, oleochemical and biotechnology platforms, the company also produces a range of speciality chemicals for other industrial markets. In addition, it offers polymer intermediates, resins and compounds. “Lonza is in the unique situation of being able to offer various manufacturing strategies based on chemistry and microbial fermentation to provide customers with the best possible solution,” says Utiger. In solid phase peptide synthesis (SPPS), Lonza can offer straightforward synthesis on solid resin supports or a hybrid approach in which various fragments are produced on solid supports and subsequently condensed in the liquid phase. The company has a solid phase synthesis capacity of multi-hundred kilos per annum of peptide APIs at the Visp site. For liquid phase peptide synthesis (LPPS), it operates production vessels in the range from 160-10,000 litres at Visp and Braine. Microbial recombinant production of peptides is carried out in vessels with various capacities up to 75 cubic metres. First investments in peptides Lonza started working in the peptides area in 1998 on the Hirulog product, a peptide containing 20 amino acids. The synthetic approach used was a combination of biotechnology and chemical synthesis. This business represented the starting point and foundation for Lonza’s investments in peptide production based on chemistry. The company differentiates itself from others by offering the three different technologies for the production of peptides on all scales and with an upper limit of 500kg peptide API per annum. In addition, Lonza offers integrated solutions by backward integration of specific, key raw materials produced in-house, solvent recycling and waste treatment on an industrial scale. Lonza’s business is driven by peptides that are in late clinical phases and commercial production and that cover highly populated indications such as diabetes, obesity, cancer and the like. A strong pipeline of products is still in clinical Phase II-III, with new emerging technologies such as modified peptides to enhance product lifetime in the blood stream. Geographically, the majority of the company’s peptides business is still in the USA, accounting for about 80 per cent. The company says Europe, Japan, Asia and Australia are emerging areas and will become more important in the future due a strong evolving biopharma scene, with robust early-phase pipelines. Significant acquisition Lonza has a broad range of capabilities in peptides manufacturing: pictured is the control system for the unloading of product. 14 MAY 2006 “The acquisition of UCB-Bioproducts, now designated as LonzaBraine, represents a significant leap for Lonza’s peptide business and reinforces our capabilities and capacity in the chemical synthesis of peptides,” says Utiger. “With this acquisition Lonza has a clear leadership position in mid- to large-scale peptide manufacturing. Besides the critical size of production, synthesis know-how and experience in all three technology areas are www.sp2.uk.com available for our customers as well as corresponding QC development expertise. In summary, out of two strong players in peptide custom manufacturing, a clear leader was formed, specialising in mid- to large-volume peptide production and the latest peptide development technologies. “Lonza is offering three different technologies for the production of peptides on all scales,” continues Utiger. “This positions Lonza in a unique way that no competitor can match. The value transferred to the pharmaceutical and biotechology sectors is twofold: the right technology mix for the production of peptides eases the manufacturing cost structure not only from the production point of view, that is, operating units, but also in terms of a reduction in the overall cost of goods.” Lonza uses liquid phase synthesis primarily for the production of small to medium-sized molecules (2-10 amino acids) on all scales; solid phase synthesis is the method of choice for production of medium to long peptides (10-50 amino acids); and biotechnology comes into play when the peptide is very long, complex in structure, and with higher volumes required. “With the acquisition of Lonza-Braine, Lonza is in the enviable position of being able to offer all technologies separately or in combination on small, medium and large scale, from grams to 500kg. Ultimately Lonza is able to offer service throughout the entire life cycle of a peptide,” says Utiger. In the next phase of Lonza’s expansion of its peptide technologies, the whole service platform will be rounded off with a strengthened position in early-phase small-scale sampling. Work in this area will be started as soon as the integration of UCB-Bioproducts is completed. The future for custom peptides “The custom service sector will consist of niche players providing specific technology tools for production of research quantities for target validation, lead identification, and so on, and of producers of commercial and clinical material. Due to the development of new delivery systems and modifications of the peptide structure, more players with proprietary technologies will enter the market as well. In addition, new generic suppliers will emerge and will be based mainly in Asian countries, Europe and Israel,” says Utiger. www.sp2.uk.com Filtration and drying are critical final stages in the production of peptides. “New delivery systems and chemically modified peptides will enable new applications for peptides. This, coupled with the generally lower toxicology risk of natural amino acid building blocks, will boost larger-volume applications in areas like diabetes, HIV, hepatitis or inflammatory applications,” he continues. “In the longer term, Lonza expects robust annual growth from its peptide business. Peptides, of course, are useful from a pharmacokinetic standpoint since their behaviour is similar to that of small molecules but also from an efficiency standpoint since they are similar to proteins. These aspects, combined with new delivery systems, make peptides versatile 2 new drug compounds,” he concludes. sp FURTHER INFORMATION Lonza Group Ltd Muenchensteinerstrasse 38 PO Box 4002 Basel Switzerland Tel: +41 61 316 81 11 Fax: +41 61 316 91 11 Internet Links: Email: [email protected] Web: www.lonza.com MAY 2006 15