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Statistical Methods For Comparing Small-Scale Models To At-Scale Biopharmaceutical Manufacturing

As the final article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale. ....

Klaus Kaiser Bayer , Caroline Leveder Sanofi , Joschka Johannes Buyel Bayer , Robertg Luo Glaxosmithkline , Kiran Andra Alexion , Committee For Human Medicinal Products , Drug Administration , Development Of Therapeutic Protein Biosimilars , Trish Connolly Biophorum Development Group , Mark Richards Eisai Inc , Public Health , European Medicines Agency , Biophorum Development Group , Joschka Johannes Buyel , Klaus Kaiser , Kiran Andra , Alexis Henry , Caroline Leveder , Mark Richards , Eisai Inc , Trish Connolly , One Sidedt Tests , Small Scale Model Workstream , Viral Clearance , Small Scale Models , Normality Assumption ,

Planning Executing Small-Scale Model Qualification For Upstream Downstream Biopharma Processing

Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing
By Joschka Johannes Buyel (Bayer AG), Klaus Kaiser (Bayer AG), Kiran Andra (Alexion), Robert G. Luo (GlaxoSmithKline R&D), Alexis Henry (Biogen), Caroline Leveder (Sanofi R&D), Mark Richards (Eisai Inc.), Trish Connolly (BioPhorum Development Group)
This article is the second in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model justification. Their purpose is to provide reference documents for bioprocess professionals who will carry out small-scale model justification. In order to write the articles, surveys were conducted among BioPhorum workstream team members on the practices of conducting small-scale model justification. The results of the surveys are not presented in these articles but are available in an expanded BioPhorum white paper on the topic. Part 1 discussed the applications, includ ....

Klaus Kaiser Bayer , Caroline Leveder Sanofi , Joschka Johannes Buyel Bayer , Robertg Luo Glaxosmithkline , Kiran Andra Alexion , Trish Connolly Biophorum Development Group , Biophorum Development Group , Mark Richards Eisai Inc , Joschka Johannes Buyel , Klaus Kaiser , Kiran Andra , Alexis Henry , Caroline Leveder , Mark Richards , Eisai Inc , Trish Connolly , Scaling Parameter , Scale Independent Parameter , Approach Upstream , கிளாஸ் கைசர் , குறி ரிச்சர்ட்ஸ் , ேசை இன்க் , ட்ரிஷ் இணை ,

Implementing Small-Scale Models For Biopharmaceutical Development

Small-scale models (SSMs) are widely used in the biopharmaceutical industry. These models are used for process development and optimization,. ....

Klaus Kaiser Bayer , Caroline Leveder Sanofi , Joschka Johannes Buyel Bayer , Robertg Luo Glaxosmithkline , Kiran Andra Alexion , Committee For Human Medicinal Products , European Medicines Agency , Drug Administration , Trish Connolly Biophorum Development Group , Biophorum Development Group , Mark Richards Eisai Inc , Joschka Johannes Buyel , Klaus Kaiser , Kiran Andra , Alexis Henry , Caroline Leveder , Mark Richards , Eisai Inc , Trish Connolly , Drug Substances , Chemical Entities , International Conference , Technical Requirements , Process Validation , Biotechnology Derived Active Substances , Human Medicinal ,