Tuesday, July 9, 2019 Daily Archives

Updates to Characterization Methods for Single Use Plastic Components Used In Pharmaceutical and Biopharmaceutical Manufacturing

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This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Leachables from single use systems have the potential to impact the quality and safety of your drug product. This presentation will help you understand those risks and how to evaluate them, the current options for test methods and what the future holds so that you can prepare. Key Questions Answered: Why is characterization of Single Use Systems Important? What is the Current State of Methods used…

July 9, 2019

Biocon going digital to fix insulin plant hit with another FDA 483

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Adopting a digital-based Quality Management System will help Biocon remediate issues at its insulin glargine facility in Malaysia, the firm says. An inspection by the US Food and Drug Administration (FDA) between June 24 and July 5 has resulted in a Form 483 with 12 observations at Indian drugmaker Biocon’s facility in Malaysia. The drug product and drug substance site will produce a follow-on insulin glargine referencing Sanofi’s Lantus intended for the US market. “We believe these 12 observations across…

July 9, 2019

M&A hungry BioLife to buy cold-chain services firm SAVSU

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Having gradually increased its stake in the cloud-based cold-chain management firm, BioLife Solutions will buy the remaining 56% of shares to bolster its cell and gene therapy offering. Supplier of cell and gene therapy tools BioLife has been experiencing huge growth over the past few quarters (51% increase year-on-year for its Q1 2019, for example) due to the high demand for bio-preservation media and automated thawing products. The firm has been looking to take advantage of the continued demand from…

July 9, 2019