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By Yadnyesh Patel, microbiology subject matter expert | This article concludes the author's series on bacterial endotoxin testing, describing best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more. |
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Who Is Responsible For Design Controls? | By Drug Delivery Leader Live | In this segment of New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio asks consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to identify which organization in a combination product manufacturing process is responsible for design controls — the sponsor company, the contracted component provider, or both. |
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| Delivering The Promise Of Gene Therapy | Article | Battelle | Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment. |
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