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.
"After Avecia finalized the first phase, the implementation of the 'Pilgrim®' integrated electronic QMS, we have now embarked on the second phase of expanding our QMS. 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,” stated Detlef Rethage, President of Avecia Biotechnology Inc.
About Avecia: Avecia Biotechnology Inc. is a drug development and manufacturing service company located in Milford, MA. The company is a recognized leader in process development; manufacturing and related services for DNA and RNA based therapeutics. Avecia has successfully completed four process validations and is preparing for a commercial supply contract. Avecia’s last three FDA inspections were completed without any FDA form 483 observations. For additional information, please visit: www.aveciabiotech.com
About BTL: BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing their technical, manufacturing, analytical, and regulatory resources. BioTechLogic is a team of professionals with expertise in process development, BioAnalytical services, process validation, project management, quality assurance, regulatory submissions and Pre-Approval Inspection (PAI) readiness. For additional information, please visit: www.biotechlogic.com and www.processvalidation.com
Avecia Biotechnology Inc.
Paula Lorence, 508-532-2500
KEYWORDS: United States North America Massachusetts
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Optical Pharmaceutical Research FDA Science