Advancing the Peptide Pipeline - Pharmaceutical Technology

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Advancing the Peptide Pipeline
The pharmaceutical majors build their capabilities in peptide technology, and contract manufacturers expand to meet growing demand for bulk peptides.

Pharmaceutical Technology

Novo Nordisk (BagsvE6rd, Denmark) also is developing a GLP-1 analog, liraglutide, which is in Phase II development.

Company Web sites
Novo Nordisk's long-acting insulin "Levemir" shows how chemical modification can alter the properties of a protein to prolong its effect. The chemical modification can be performed on the isolated protein by linking a small molecule or side chain to the protein. In the case of Levemir, the activated lipid acid is synthesized and coupled to the primary amino group of lysine in the protein, resulting in an insulin analogue with tailored properties, says Novo Nordisk.

Other players target peptides

Certain generics companies are positioning in peptides. Last month, Ranbaxy Laboratories Ltd. (Gurgaon, India) and Jupiter Biosciences Limited (JBL, East Marredpally, Secunderabad, India), a contract manufacturer of peptides, agreed in principle to form a strategic business alliance under which Ranbaxy would acquire a 14.9% share of JBL. JBL's board approved the alliance in principle, according to a JBL filing with the Bombay Stock Exchange.

Jupiter Bioscience (US), a JBL subsidiary, is setting up a CGMP facility in Frederick, Maryland for manufacturing custom peptides, clinical peptides, and peptide-based generic APIs with an initial investment of $4 million. The facility is scheduled to open in August 2007.

In 2006, JBL acquired a manufacturing facility in Khazipally, India with capabilities for bulk production of APIs and drug intermediates. Jupiter will use this facility to produce advanced organic and chiral intermediates and and bulk supplies of peptide raw materials.

Amylin. In addition to Byetta, Amylin's other commercial peptide is "Symlin" (pramlintide), a synthetic analog of human amylin for treating Types 1 and 2 diabetes. The drug is a synthetic 37-amino-acid polypeptide. The contract manufacturer Lonza (Basel, Switzerland) and Bachem supply the peptide to Amylin, according to Amylin's annual report.

Contract manufacturers expand

As the pipelines of Big Pharma, emerging drug companies, and generics players fill with select peptide-based drug candidates, several contract manufacturers of peptides are expanding manufacturing internally and by acquisition.

Peptisyntha. Earlier this year, Peptisyntha SA (Brussels, Belgium) launched the expansion of its pilot-scale production capacity for bulk peptides based onsolution-phase technology at its plant in Brussels, Belgium. The expansion includes an additional pilot high-performance liquid chromatography unit, an additional pilot freeze-dryer, and an additional pilot plant for the chemical synthesis of peptides. All the units are scheduled to be fully operational during 2007. Peptisyntha completed construction and validation of CGMP quality-control laboratories at the same site in 2006.

Peptisyntha's expansion in Brussels follows its recent expansion of solid-phase peptide synthesis capacity at its site in Torrance, California, which came on stream in 2006.

Peptisyntha is part of the Solvay Group (Brussels, Belgium), the chemicals and pharmaceuticals company, which also includes Solvay's contract manufacturing activities in small molecules. Solvay holds a controlling interest in Girindus SA (Bensberg, Germany), is a producer of oligonucleotides and radiolabeling services. It operates laboratories and pilot-plant facilities in Cincinnati, Ohio, which also is the site for its commercial-scale oligonucleotide production.


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