PolyPeptide Laboratories - Active Pharmaceutical Ingredient (API) Manufacturer, Custom and gmp peptides

PolyPeptide Laboratories is a privately held group of GMP peptide manufacturing companies that provides custom peptide and GMP standard peptide products and services to the pharmaceutical and biotech industries. Our services include bulk cGMP manufacture, custom development, peptide generics as well as non-GMP small-scale custom synthesis for life science research. Our GMP peptide services include all documentation and support to take projects through to approval. Polypeptide Laboratories also offers large-scale contract purification services for peptides.

PEPTIDE EXPERTISE

The PolyPeptide Laboratories Group employs a total of about 300 staff worldwide at subsidiaries in Torrance (United States), Hillerod (Denmark), Malmo (Sweden), Prague (Czech Republic) and Wolfenbuettel (Germany). Due to the geographic locations of the national subsidiaries and the diversity and depth of peptide knowledge of our scientific staff, we are a truly multinational group whose main assets are our personnel. Many of our scientists and technicians have been working on peptide manufacturing projects together at the same sites for over 20 years.

LARGE SCALE cGMP PEPTIDE MANUFACTURING

In over 200,000ft² of modern manufacturing suites and associated laboratories, the PolyPeptide Laboratories Group has over 11,000L solution phase reactor capacity, solid phase reactors up to 270L in size and over 1,000L of tray lyophilizer capacity. Technologies include large-scale solid phase peptide synthesis (SPPS) using Boc- and Fmoc-strategies as well as solution (liquid) phase peptide synthesis (LPPS) and fragment synthesis. The current output exceeds 100kg peptide per year. The facilities in Torrance and Scandinavia all have large-scale cGMP manufacturing and regulatory capabilities. The PolyPeptide Laboratories Group is ideally suited to supporting regulatory submissions for cGMP peptides in both Europe and the United States.

CUSTOM DEVELOPMENT AND SUPPLY OF PROPRIETARY PEPTIDE APIS

Due to the wide range of services offered within the company group, we can produce custom peptides from the laboratory bench through the development of a large-scale manufacturing process to registration and beyond. We offer the most complete package of GMP services in the pharmaceutical industry. Our unswerving insistence on rigorous analytical characterization and complete GMP compliance in the initial stages of any GMP campaign is not only the hallmark of our company, but has been the pivotal factor in the success of many commercial projects.

PEPTIDE GENERICS

The PolyPeptide Laboratories Group manufactures peptide-based generic APIs for the human and veterinary pharmaceutical market. These include:

• ACTH
• Buserelin
• Calcitonin
• Deslorelin
• Felypressin
• Gonadorelin
• Goserelin
• Lecirelin
• Leuprolide
• Octreotide
• Oxytocin
• Somatostatin
• Triptorelin
• Vasopressin

These peptides, which are manufactured under cGMP according to European and US Pharmacopoeia, are usually available from stock. DMFs and COSs are available for many of these peptides.

SMALL-SCALE NON-GMP CUSTOM SYNTHESIS OF PEPTIDES

PolyPeptide Laboratories also offers small-scale custom synthesis services to support basic research, in particular for pharmacological investigations which require exceptionally pure substances. Research grade peptides and peptide derivatives - usually quantities between 25mg and a few grams - are routinely synthesized to 97% purity by skilled technicians. Our manual technology allows us to control each step, repeating reactions where necessary. The combination of high yields and proprietary purification procedures is particularly adaptable for subsequent scaling-up to larger quantities of custom peptides and other products.