GMP peptide plant planned downunder
Zealand has awarded a lump sum to two Antipodean firms which will
result in a new good manufacturing practice (GMP) compliant peptide
manufacturing plant in the under-served Southern Hemisphere.
Australian peptide specialist Mimotopes and New Zealand-based chemical synthesis firm GlycoSyn have been awarded NZ$715,000 (€388,000) by the Australia New Zealand Biotechnology Partnership Fund, which will be matched by GlycoSyn's parent company Industrial Research Limited, bringing the total fund to enable to new peptide production capabilities to NZ$ 1,430,000. The funds will go towards upgrading GlycoSyn's current facility in Lower Hutt, New Zealand, with a significant proportion dedicated to commissioning specialist equipment for peptide synthesis and achieving GMP compliance, with the remainder going towards business development activities. GlycoSyn's 6,000sq ft. facility is already GMP compliant for the manufacture of small molecules for pre-clinical and clinical trials through to Phase II, and currently boasts a 20L and 50L pilot plant for scale up and non-GMP manufacture, and gram-scale process development laboratories. The two companies expect to be ready to supply GMP peptides from the facility within three months, in-PharmaTechnologist.com was told. "In Australasia in particular there's a lack of facilities for peptide manufacture to GMP requirements," Nick Ede, chief scientific officer at Mimotopes explained. "Initially the joint venture will focus on the Australasian market and supplying peptides for early stage clinical trials, but in future we intend to become a powerhouse in the supply of GMP peptides worldwide." The new GMP peptide facility will be only the second in the Southern Hemisphere, joining Australian firm Auspep's GMP certified plant in Melbourne, which has been providing GMP peptides to major pharma firms since last year. Combining Mimotopes' experience in peptide chemistry with GlycoSyn's GMP manufacturing expertise is hoped to result in a fruitful partnership that could see significant income for both firms in this fast-growing sector of the pharmaceutical market. Tim Boyd, general manager of business development at GlyoSyn is enthusiastic about the joint venture and the "potential of the alliance to generate significant revenues and earnings for both companies [by filling] an immediate need in both the local and international drug development markets". The partnership will also benefit both companies by improving their capabilities in the synthesis of glycopeptides and peptidomimetics (small, protein-like chains designed to mimic a peptide), both important compounds in the development of drugs and peptide vaccines. The deal will also be additionally valuable to Mimotopes following the company's strategic alliance with US biotech firm Genzyme Pharmaceuticals last year. That deal allowed Mimotopes to supply customers with research grade peptides and related services up to the point of lead candidate identification in pre-clinical applications, after which Genzyme would take over supplying GMP peptides through to clinical applications and therapeutic grade peptides and related services. By aligning itself with GlycoSyn in this latest agreement, Mimotopes can fill a gap in its existing alliance by providing GMP peptides for early stage trials as well. With GlycoSyn taking care of the manufacturing aspect from its New Zealand site, Mimotopes will focus on applying its peptide expertise and the sales and marketing side of the joint venture.
