“The therapeutic peptides market is still predominantly U.S.-oriented,” says Dr. Devenyns. More than two-thirds of demand comes from the U.S. market. The bulk of solid-phase synthesis capacity resides in the U.S., with solution-phase operations primarily located in Europe.
In describing the competitive landscape outside the U.S., Dr. Devenyns points to a trend in which peptide companies have gone through a round of consolidation and are currently looking to the east for increasing the scope of their manufacturing operations.
At Peptisyntha, the expansion under way at its Torrance, CA, site continues. The new QC/QA laboratories and offices, is scheduled to be ready by March. The company has also leased an additional building adjacent to its existing facility that will provide increased production capacity in 2010—predominantly for solid-phase peptide synthesis.
At the Brussels site, where the company’s solution-phase manufacturing capability is based, Peptisyntha took into operation new QC labs and a new synthesis pilot over the past 6-12 months. Additionally, new GMP warehouses went into use earlier this year in Brussels for receipt and storage of materials under controlled conditions. All of these expansions were built to comply with cGMP standards.
A key goal for 2009, according to Dr. Devenyns, is the installation and validation of a manufacturing execution system that will automate series of workflow processes involved in peptide production. This will include automated follow-up of the flow of materials moving in and out of the company’s new warehouses and will constitute the backbone of a productivity upgrade. Additionally, new pilot capacity for purification and lyophilization will also be brought on-stream. Peptisyntha was inspected in August 2008 by the Belgian Federal Agency for Medicines and Health Products, on behalf of EMEA, and a GMP certificate was granted.
With the acquisition of NeoMPS, previously the peptide manufacturing arm of Isochem, and its facilities in Strasbourg, France, and San Diego, PolyPeptide Laboratories has added substantial manufacturing capacity to its ongoing GMP operations in the U.S., Denmark, Sweden, and India. It also broadened its range of offerings, providing services to organizations seeking catalog peptides, radio-labeling services, small-scale non-GMP synthesis, as well as contract manufacture of amino acid derivatives and organics.
The acquisition of NeoMPS gave PPL a “broader window for pipeline projects,” says Lax, in particular enabling the company to pursue more small-scale GMP projects, such as vaccine production, for which initial GMP lots typically require only about 10 grams of peptide, as well as the general ability to compete for earlier-stage projects.
About 35% of PPL’s business is in generic peptides, which Lax describes as an established market that will likely remain fairly stable even in the current economic uncertainty. An additional 25% of the company’s revenue stream depends on contracts with large pharmaceutical companies, adding to Lax’s confidence that PPL is in a good position to weather the economic storm.
The company’s new facility in India will be operational later this year and will be dedicated initially to generic peptide production. Expansion of manufacturing capacity is also ongoing in Scandinavia and Torrance.