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The PolyPeptide Group is a privately-held group of manufacturing companies that focus on proprietary and generic good manufacturing practice (GMP) grade peptides for the pharmaceutical, cosmetic and biotechnological market.
With more than 50 years of experience, the Group provides high-quality peptide manufacturing for approved drug substances, clinical trials and small-scale non-GMP custom syntheses.
With its multi-national organisation, strict focus on peptides and solid financial base, the group offers an almost unique security of supply to its customers.
The group has six GMP facilities located across Denmark, France, India, Sweden and the US.
All of its facilities are dedicated towards GMP-grade peptide manufacture in quantities ranging from grams to tens of kilograms.
The flexibility of the production can be of great value to the PolyPeptide Group’s customers, depending on the location of their clinical trials and regulatory filings. Furthermore, these multiple sites ensure production stability.
The group has a long history of current good manufacturing practice (cGMP) compliant manufacture and has more than 20 approved drug substances worldwide.
The PolyPeptide’s Group generic portfolio is constantly expanding and includes well-known peptides such as calcitonin, desmopressin, leuprolide and octreotide, as well as newly off-patent peptides such as eptifibatide and bivalirudin.
The group explicitly commits to a long-term continuous supply and cost-competitiveness of high-quality peptide active pharmaceutical ingredient (API) manufacturing up-to very high volumes.
Available services include support for regulatory and approval processes, as well as full GMP documentation or all of the company’s generic products.
The PolyPeptide Group supplies a full spectrum of services for peptide synthesis, including:
•  A comprehensive catalogue of more than 1,250 bioactive peptides
•  Custom synthesis of research-grade peptides, stable and radioisotope-labelled peptides, and production of antipeptide antibodies
•  Lead optimisation, pre-GMP and process development for future scale-up, including bulk non-GMP manufacture
A dedicated catalogue section includes over 700 special amino acids and derivatives, building blocks and turn mimics, all available from stock. Custom organic chemicals can also be developed in house. We can also provide custom synthesis of non-peptidic molecules, from several grams to several hundreds of grams and cGMP manufacturing at kilogram scale.
The Group has laboratories dedicated to the chemistry of amino acids, solution-phase peptide synthesis and traditional organic chemistry. Laboratory protocols can be scaled up to pilot scale or full scale manufacturing in reactors up to 650l.
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 commercialisation. 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.
PolyPeptide Laboratories A/S
Herredsvejen 2
3400 Hillerød
Denmark
Tel: +45 48207000
Fax: +45 48207005
ppl@polypeptide.com
www.polypeptide.com