Polypeptide Laboratories, Inc.

PolyPeptide Laboratories, Inc. was established in 1996 as the US subsidiary of the PolyPeptide Laboratories Group. The Group is one of the world's largest companies specializing in the manufacture of peptides for therapeutic applications, and has facilities in Torrance, California, Malmö, Sweden, Hillerød, Denmark, Wolfenbüttel, Germany and Prague, Czech Republic . Although the name "PolyPeptide Laboratories" is new, the members of the Group have a very long history and a wealth of experience in the peptide field.

A key advantage PolyPeptide Laboratories offers is its extensive experience in all aspects of solid- and solution-phase peptide chemistries. The US company occupies a new, state-of-the-art, 20,000 square-foot GMP production facility which was recently approved as a GMP manufacturing facility following an extensive Pre-Approval Inspection by the US FDA. Numerous GMP-grade products have already been completed and shipped from the facility and additional pharmaceutical projects are in-process. The US facility is fully operational, with the capacity to manufacture peptides in lots of grams to multi-kilograms, by solid-phase or solution-phase methodologies, depending on the peptide, the requirements and the timing of the project. In Europe, the Group has the capacity to develop solution-phase processes on a scale of up to 1000 liters, in both the Danish and Swedish facilities, where some products are currently being manufactured in quantities exceeding 50 kg per year. Thus, within the Group, the capacity, the flexibility, and the range of peptide technologies exist to support customers' requirements at every stage of the development process.

The Group's regulatory staff in the US and in Europe has very extensive experience in filing Drug Master Files for the FDA and other regulatory agencies, and supporting products from early development through NDA approval and commercial introduction. The Group currently produces a number of peptides that have been approved (or are awaiting approval) for therapeutic use in the US and/or Europe, including Somatostatin, Goserelin, Leuprolide, Gonadorelin, Goserelin, Octreotide, Salmon Calcitonin, Vasopressin, Salmon Calcitonin, Deslorelin and Triptorelin. Furthermore, both the US and Swedish facilities have successfully undergone extensive Pre-Approval Inspections by the US FDA. This extensive regulatory knowledge and GMP manufacturing experience is a critical advantage that the Group brings to every project, and is an instrumental component to the ultimate success of any clinical project.

The combination of technical know-how, state-of-the-art production facilities and regulatory experience that exists within the PolyPeptide Laboratories Group is second to none and represents a guarantee of success for any peptide manufacturing project.

Products

cGMP Custom and cGMP Generic Peptide Sequences including:

Leuprolide

Goserelin

Octreotide

Gonadorelin

Somatostatin

Salmon Calcitonin

Vasopressin

Deslorelin

PTH

GHRP

GLP

Glucagon

Triptorelin