Avecia Biotechnology recently engaged BioTechLogic to guide the second phase of its electronically integrated QMS system. The move is designed to streamline Avecia's QMS processes and was in response to anticipation of commercial manufacture.
In April 2010 Avecia announced a manufacturing agreement with Pfizer for the commercial supply of the oligonucleotide component of Macugen. Two other clients of Avecia are planning to apply for marketing approval in 2011. Avecia has already validated the manufacturing processes for these two oligonucleotides and has also successfully completed process validations for two other customers.
The company contends that the QMS work should benefit Avecia’s late clinical stage and future post-approval clients through a robust, efficient and proven QMS which should ease the client’s project implementation. The planned marketing approvals will lead to inspections by the FDA and the EMEA.
"After Avecia finalized the first phase of implementing the 'Pilgrim' integrated electronic QMS, we have now embarked on the second phase of expanding our QMS," stated Detlef Rethage, president of Avecia Biotechnology. "This follows very positive progress within our client base and the desire to be as efficient as possible in achieving full compliance for commercial manufacture of oligonucleotides. The first phase of the implementation has already yielded very significant benefits in improved productivity throughout the quality procedures and we now look forward to further improvements."