PolyPeptide Group - Peptide Synthesis and GMP Manufacturing

The PolyPeptide Group is a privately-held group of manufacturing companies that provides proprietary and generic GMP-grade peptides for the pharmaceutical, cosmetic and biotechnological market. With more than 50 years of experience, and as a world-leading peptide manufacturing organization, the Group is committed to the highest quality of peptide manufacturing, irrespective of whether this is for approved drug substances, GMP peptides in clinical trials, or small-scale non-GMP custom syntheses.

Peptide projects from conception to commercialization

The acquisition of NeoMPS in 2007 by the PolyPeptide Group complements its long-established core strength in GMP manufacturing and broadens its range of services to support peptide projects from their conception through to commercialization.

With its increased capacity for GMP manufacturing and expanded capabilities for small-scale non-GMP custom peptides, the PolyPeptide Group has become stronger and better equipped to serve the needs of its customers at all stages of pharmaceutical peptide development. With its multinational organization, strict focus on peptides and solid financial base, the Group offers an almost unique security of supply to its customers.

GMP manufacturing - active pharmaceutical ingredients (APIs)

The Group has six GMP facilities located across three continents: Denmark (Hillerod), France (Strasbourg), India (Mumbai), Sweden (Malmö) and the US (San Diego and Torrance). GMP-grade peptides can be manufactured at all facilities, in quantities ranging from grams to tens of kilograms. The flexibility of the production site can be of great value to customers, depending on the location of their clinical trials and regulatory filings. Furthermore, the multiple sites ensure clients have stability and security in production.

The Group has a long history of cGMP-compliant manufacture and has successfully undergone more than 20 FDA pre-approval and site inspections. Altogether, the Group has over 20 approved drug substances worldwide.

Generic peptides

The generic portfolio of the PolyPeptide Group is constantly expanding and includes well-known peptides such as Calcitonin, Desmopressin, Leuprolide and Octreotide as well as new generic peptides like Eptifibatide, Bivalirudin, Exenatide and Lanreotide. The services include support for all regulatory and approval processes, and full GMP documentation is provided for all generic products.

Peptide synthesis

The PolyPeptide Group also supplies a full spectrum of complementary services for peptide projects, including:

• A comprehensive catalogue of more than 1,250 bioactive peptides, from the simplest to the most complex molecules
• Custom synthesis of research-grade peptides, stable and radio isotope-labeled peptides, and production of antipeptide antibodies
• Lead optimization, pre-GMP and process development for future scale-up, including bulk non-GMP manufacture

Organic chemistry services

A dedicated catalogue section includes more than 700 special amino acids and derivatives, building blocks and turn mimics, all available from stock. Custom organic chemicals can also be developed in-house. The Group can also provide custom synthesis of non-peptidic molecules, from several grams to several hundreds of grams and cGMP manufacturing at the kilogram scale.

As an international company with about 450 employees worldwide, an exclusive focus on peptides, a solid financial base, and a proven and established track record with the FDA, the PolyPeptide Group offers an almost unique security of supply to its customers.