Singapore: BioAzure Technologies the exclusive distribution partner for US-based Repligen has launched an enhanced line of Repligen's bioprocessing products in India. In addition to Repligen's Protein A offerings in the region, the company's growth factor products for cell culture fermentation, as well as its OPUS pre-packed chromatography columns for purification will now be made available in India. BioAzure had entered into an exclusive distribution agreement with Repligen in 2011.
BioAzure recently exhibited Repligen' s bioprocessing products at this year's BioPharma India Convention, that was held in Mumbai last week. Dr Adrian Almeida, co-founder, BioAzure, stated, "Repligen's products are used by many of the world's leading biotech companies. Through our distribution partnership, we now make them available to our clients here in India, injecting their product development processes with world-class, regulatory compliant and highly competitive products."
BioAzure co-founder Mr Karl Pinto added, "BioAzure was founded with the intent of supporting the Indian biotechnology industry with quality products, services and expertise, from in-licensing cell line clones to scale-up process development and GMP manufacturing, as well as complete regulatory-approved analytics and formulation capability. We deliver these products and services through our exclusive relationships with name-brand, world class companies in the space, coupled with our hands-on experience with GMP biologic product development."
Through the acquisition of Novozymes Biopharma Sweden in December 2011, Repligen extended its portfolio of products into the upstream cell culture space with their line of growth factors. As regulatory guidelines have tightened, biopharmaceutical manufacturers continue to shift toward efficient, animal-free cell culture processes.
Repligen's recombinant growth factors, have been developed to provide the benefits of serum-derived supplementation while maintaining a defined and consistent animal-free process. Repligen's primary growth factor product is LONG R3IGF-1, a more biologically potent alternative to recombinant insulin.
The OPUS (Open Platform User Specified) line extension is being introduced in response to rising market demand for disposable technologies in biopharmaceutical manufacturing. OPUS pre-packed, single-use plastic chromatography columns are suitable for process-scale, multi-cycle purification of biologics such as monoclonal antibodies, proteins and vaccines. The OPUS product line is unique in providing customers with an open platform to accommodate an unprecedented range of options in chromatography media, column sizes and bed heights.
The scalability and immediate "plug-and-play" usability of OPUS columns increases facility flexibility and can improve the speed of process development and reduce the cost of biopharmaceutical manufacturing by decreasing the set-up, cleaning and validation times associated with traditional purification technologies.