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| Considerations In Sterility Testing And Assurance | Mammalian cells play a crucial role in the biopharmaceutical industry for producing complex molecules such as recombinant proteins and monoclonal antibodies. Ensuring the safety of these products requires rigorous control of microbial contamination throughout cell culture batches and downstream processing. Sterility assurance is vital in this context, encompassing all measures aimed at eliminating viable microorganisms that could jeopardize patient safety. Learn more about sterility testing and assurance here. |
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| Mixing Cannabis-Infused Products | Q&A | Charles Ross and Son Company | Gain insights from a pharmaceutical equipment manufacturer on factors cannabis manufacturers should consider when they're looking to purchase a mixer. |
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By John W.M. Claud and Mark I. Schwartz, Hyman, Phelps & McNamara | The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront. | |
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INDUSTRY INSIGHTS CONTINUED |
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| Vial Fogging: Practical Considerations For Vial Selection | White Paper | By Gregory Sacha, Ph.D., and Kevin Bond, Ph.D., Simtra BioPharma Solutions | Vial fogging is a common phenomenon observed in lyophilized biologic drug products. Examine two case studies that review critical factors contributing to vial fogging and inform vial selection decisions. |
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| Next Generation Sequencing In Viral Safety Testing | White Paper | By Victor Muthu, Ph.D., Eurofins | Next Generation Sequencing offers a sensitive, high-throughput solution for detecting adventitious viral agents to improve safety and accelerate regulatory-compliant product development. |
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| How To Avoid Sticking And Picking In The Tableting Industry | White Paper | Natoli Engineering Company, Inc. | Find out more about strategies to mitigate sticking and picking risks in the tablet industry, and how you can foster improved tablet production processes to ensure higher quality and consistency. |
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| A Roadmap To Expedited Review Pathways | Article | Quotient Sciences | Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. |
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| Join us for Pharmaceutical Online on October 15 at 11 AM ET! Chief Editor Katie Anderson hosts a free, interactive webinar—Balancing GLP-1 Quality with Demand—featuring expert panelists discussing peptide manufacturing, supply chain strategies, assay development, tech transfer, and more. Sponsored by Waters. Register now! |
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