During a May 2021 “Ask the Expert†presentation, Jigisha Patel (vice president of global regulatory compliance and technical services at Spectrum Chemical Manufacturing Corporation) emphasized the need to minimize supply-chain contingencies that lead to variability across raw materials used in biopharmaceutical manufacturing. Deviations in raw-material specifications can jeopardize good manufacturing practice (GMP) compliance and reduce drug-product efficacy and stability. Patel explained how her company’s quality management system ensures that bioprocess materials will meet specifications and process needs. Patel’s Presentation Patel…
Friday, September 17, 2021 Daily Archives
CEVEC and UCB ink AAV manufacturing agreement
UCB will use CEVEC’S adeno-associated virus (AAV) vector manufacturing technology platform to research, develop and produce AAV gene therapy products. Under the terms of the agreement, CEVEC Pharmaceuticals will grant UCB the non-exclusive rights to its ELEVECTA technology to research, develop, and manufacture Adeno-Associated Virus (AAV) vectors for gene therapy applications. The deal also provides UCB with the option to obtain licenses for use of the ELEVECTA producer cell lines in commercial production of potential AAV gene therapy candidates, and…
Protein boost for Repligen through $150m Avitide buy
The latest acquisition by Repligen will boost its proteins business, adding bespoke affinity purification ligand manufacturer Avitide. The deal sees bioprocess vendor Repligen Corporation shell out $75 million in cash and $75 million in stock for Lebanon, New Hampshire-headquartered firm Avitide. Avitide is a manufacturer of chromatography resins used in downstream bioproduction and its bespoke commercial offering will bolster Repligen’s own proteins business and its affinity ligand discovery service. Repligen’s legacy proteins business – which includes its Protein A chromatography…