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By Kalie E. Richardson, Hyman, Phelps & McNamara | A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear. |
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By Andrew Walsh, Thomas Altmann, Joshua Anthes, et al. | New standards rely on quality risk management tools to control risk in cleaning process development, validation, and monitoring. |
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| Welcoming The “Era Of ADCs” | Article | Cytiva | Dr. Loretta Itri sat down to explore the promise of TRODELVY®️ and other antibody-drug conjugates as transformative treatments for a range of malignancies and intractable diseases. |
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FOCUS ON ANALYTICS & QUALITY |
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| Setting Expectations For Post-Thaw Segment QC Testing On A CBU | Poster | Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Examine the post-thaw segment QC results for 2,249 consecutive segments cut at our institution, in order to create a benchmark of what is to be expected when interpreting segment testing. |
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| Can Today’s ELNs Support Tomorrow’s Labs? | Article | By Stuart Ward, IDBS | The global electronic laboratory notebook (ELN) market is growing, however, ELNs must form part of a more comprehensive data strategy and ecosystem or they can impede progress. |
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ANALYTICS & QUALITY SOLUTIONS |
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