Avecia Biotechnology Inc. Has Engaged BioTechLogic as Consultants to Assist in Expanding Its Quality Management System (QMS) and in Preparing for Post Approval Manufacturing
11/15/2010 10:57:01 AM
MILFORD, Mass.--(BUSINESS WIRE)--In April 2010 Avecia announced a manufacturing agreement with Pfizer for the commercial supply of the oligonucleotide component of Macugen®. Now 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. In anticipation of commercial manufacture, Avecia is now progressing with the second phase of its electronically integrated QMS system with consultative guidance from BioTechLogic. In particular this is designed to further streamline its QMS processes. The results 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 European agency EMEA.
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