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Barry Cherney on Muck Rack

Barry Cherney

As seen in: BioProcess International Magazine
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Articles

Production Cell Line Development And Control of Product Consistency - Myths, Risks, and Best Practices - BioProcess International

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By Barry Cherney, Dieter Schmalzing, Steffen Gross, Juhong Liu
| BioProcess International Magazine Verified
Health authorities are requesting substantial details from sponsors regarding practices used to generate production cell lines for recombinant DNA–(rDNA) derived biopharmaceuticals. Authorities also are asking for information about the clonality of master cell banks (MCBs) and control strategies to minimize genetic heterogeneity. Such requests are prompted by recent reports indicating “nonclonality” for certain production cell lines.
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eBook: Production of Cell-Line Development and Control of Product Consistency During Cultivation — Myths, Risks, and Best Practices - BioProcess International

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By Barry Cherney
| BioProcess International Magazine Verified
Health authorities are requesting substantial details from sponsors regarding practices used to generate production cell lines for recombinant DNA–(rDNA) derived biopharmaceuticals. Authorities also are asking for information about the clonality of master cell banks (MCBs) and control strategies to minimize genetic heterogeneity. Such requests are prompted by recent reports indicating “nonclonality” for certain production cell lines.
Open in Who Shared Issue with article?
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