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PolyPeptide Group

Proprietary and Generic GMP-Grade Peptides

September 7, 2010

Quality by Design: A Peptide CMO Approach

Anders Tsirk, PhD, Process R&D, PolyPeptide Group
pharmacuetical business review


PolyPeptide Group

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.

GMP manufacturing and pharmaceutical peptide projects

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.

GMP-grade peptides and API

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.

Calcitonin, desmopressin, leuprolide and octreotide generic peptides

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.

Peptide synthesis

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

Organic chemicals and amino acids

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.

About Polypeptide Group

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

Tel: +45 48207000
Fax: +45 48207005

Quick Contact PolyPeptide Group

Generic Peptides

The PolyPeptide Group offers you a number of generic peptides, produced on an industrial scale under cGMP. Our generic peptides are sold to the bulk market worldwide.

Please note that regional minor differences in analytical procedures and acceptance criteria might occur. Also, some confidential data has been removed from the website specifications. Our product range includes the following peptides: ACTH (Corticotropin) synthetic Carbetocin Calcitonin Deslorelin Desmopressin Felypressin Gonadorelin Acetate Gonadorelin, HCl Goserelin hPTH (1-34) Leuprolide Octreotide Oxytocin Somatostatin Vasopressin, 8-L-Arginine For any…

GMP Contract Peptide Manufacturing

Once a proprietary manufacturing process has been validated and approved, and no additional GMP custom peptide development is required, the production of the peptide becomes one of contract manufacturing.

Depending on the scale of the manufacturing process and the annual requirements for the peptide, the process may be transferred to a manufacturing suite dedicated specifically to the peptide API (Active Pharmaceutical Ingredient). Contract manufacturing (of proprietary peptides) can be performed at any of our cGMP facilities worldwide. Most contract manufacturing processes are currently performed…

GMP Custom Peptide Development

We manufacture peptides up to 50 amino acids in length and in quantities that can range from a gram to multi-10kg quantities. Our robust, economical manufacturing processes help optimise the cost of development.

A full range of synthetic technologies are available. The final choice depends on the sequence length, the scale, and the specific project requirements. Large-Scale Liquid (Solution) Phase Peptide Synthesis (LPPS) LPPS is the technology of choice for manufacturing short peptides or structures that are inappropriate for a resin matrix. This approach ultimately provides a cost-effective…

Organic Chemistry

Includes all available chemical reactions.

Custom Non Peptidic Molecules From the simplest to the most complex structures From several grams to several hundreds of grams cGMP manufacturing at kilogram scale Chemical Reactions Available Acetylation Friedel-Crafts Alkylation Alkylation Gabriel synthesis Amidation Grignard Reaction Amination Hofmann Rearrangement Beckmann Rearrangement Hydrogenation Bromination Metal Hydride Reduction Bucherer-Bergs (hydantoin synthesis) Mitsunobu reaction Chemical Resolution Nitration…

Research Peptides

Non GMP commercial solutions.

Quantities for research up to pilot scale can be provided at predefined purity levels, and can include modifications such as cyclisation, biotinylation, phosphorylation, as well as labeling with fluorescent dyes or radioactive isotopes. Pre-GMP Analytical Development Analytical characterisation of any lead peptide designated for GMP manufacture is started as soon as the campaign starts. The…
Quick Contact PolyPeptide Group
Quick Contact PolyPeptide Group

Quick Contact PolyPeptide Group
Quick Contact PolyPeptide Group
Quick Contact PolyPeptide Group

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