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10 22 21 -- Essential Components Of A Sterility Assurance Program

10/22/21 Pharmaceutical Online Newsletter

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End-User Evaluation Of 30 L And 300 L HyPerforma Single-Use Fermentors And Scale-Down Model

In moving processes from bench to pilot and ultimately production fermentors, it is critical to have a reliable scaledown model. Scale-down models.

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Production Of Therapeutic Plasmid DNA In Single-Use Fermentors

Production Of Therapeutic Plasmid DNA In Single-Use Fermentors
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01 14 21 -- Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues

01.14.21 Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues This report helps biopharmaceutical companies make more informed CMO decisions and helps CMOs optimize operational and marketing strategies. ISR presents data on 509 service encounters from 179 respondents who have been involved in outsourced biologics API projects in the past 18 months. Learn more here. Featured Editorial By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA s new Q&A 7 and Q&A 8.

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