Thursday, March 2, 2023 Daily Archives

Application of an Effective In-Line Analytical Instrument for Biopharmaceutical Development and Manufacture

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The rapid advancement and competitiveenvironment of the modern biopharmaceutical industry, accompanied by the need for continuous quality improvement, demand robust analytical instruments. Analytical technology is one key factor contributing to the quality and safety of finished products. Ongoing improvements in analytical instruments are needed to address new challenges, including specificity of target substances, high complexity of matrices, and multiple production stages with a number of input and output parameters and peculiarities. Those factors point to the demand for a versatile…

March 2, 2023

Amid FDA questions, BioMarin confident of Roctavian approval timeline

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BioMarin still expects a US approval decision for gene therapy Roctavian by March 31 despite FDA data demands and observations made during a pre-licensure inspection at a manufacturing facility in California.  BioMarin is hoping to win US approval for its single-dose hemophilia A gene therapy this month, with a proposed US Food and Drug Administration (FDA) PDUFA (Prescription Drug User Fee Act) date for Roctavian (valoctocogene roxaparvovec) of March 31. However, this date could be compromised following a pre-licensure inspection…

March 2, 2023

Pfizer automating transcription for future mRNA development

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End-to-end fully automated in vitro transcription (IVT) reactions can increase process throughput in the development of messenger RNA (mRNA) vaccines and therapeutics, says Pfizer. Among the discussions centering on bioprocess automation at the BPI West Conference in San Diego, California this week was Pfizer’s reflection on its latest research into a fully automated and streamlined IVT reaction. IVT is used to transcribe genetic information from DNA to RNA, and the generated mRNA transcript is used to produce proteins in cells. Karena Smith,…

March 2, 2023