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Biomay Extends GMP Manufacturing Authorization for Phase III and IV Biologicals (14 Sep. 2012)

Biomay announces the successful extension of its manufacturing authorization for biologicals for all clinical phases and for market supply. The respective authorization and certificate of GMP compliance were granted recently to Biomay by the Austrian Agency for Health and Food Safety (AGES).

 

The company now is enabled of manufacturing of phase I – IV drug substance biologicals (recombinant proteins or plasmid DNA) with microbial expression systems such as bacteria and yeasts. In addition, Biomay now has permission for to the certification and batch release of human investigational medicinal products (drug product) for clinical phases I – III, and of human medicinal products for market supply (phase IV).

 

“We are very proud that we now have demonstrated GMP compliance even for clinical phases III and IV,” states Biomay´s Head of Quality Assurance, Theresa Steinberger, who managed and concluded the company´s application project, “the hard work of our team during the last months was rewarded by reaching this important milestone. The extension of the manufacturing authorization is indeed a crucial step for Biomay´s further advancement.”

 

Hans Huber, Biomay´s COO, comments: “First of all, the new GMP authorization will enable us performing the whole CMC program for our own allergy-related products during all clinical phases for ourselves. In addition, we have now the perspective of in-house manufacturing of our own products even after market registration, a definitely realistic scenario by considering the relatively low doses applied in allergy specific immunotherapy.” Referring to Biomay´s services as a contract manufacturing organization (CMO), he further elaborates: “our clients will profit as well from this achievement, on the one hand by our generally advanced GMP compliance, and on the other hand by our extended scope of services, ranging now until phase III and IV manufacturing.”

 

Biomay´s manufacturing services and capacities

As a CMO, Biomay offers GMP contract services based on microbial systems for manufacturing of recombinant allergens, therapeutic proteins, antibody derivatives and plasmids (DNA vaccines). The scope of Biomay´s CMO services comprises strain, process and assay development, process and assay validation, cell banking, manufacturing of drug substance, aseptic filling of drug product (sub-contracted), in-house QC testing and batch release, stability testing and regulatory support (IMPD/IND). Final batch sizes range up to 10 g drug substance. The fully integrated facility consists of two independent GMP manufacturing suites (clean room classes A, C and D). 

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