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| Webinar: Implementing PIC/S Annex 1: Contamination Control Strategy with QRM Principles | Be sure to attend on November 19th as we cover the fundamental principles of contamination control, including the identification and management of contamination hazards, risk mitigation strategies, and the alignment of these strategies with QRM methodologies. Participants will gain a clear understanding of how to organize and document contamination control measures across various processes, while ensuring regulatory alignment and minimizing the risk of non-compliance. |
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| How To Prove A Sterility Assurance Level Of 10⁻⁶ | Article | By Kurt McCauley and Laurent Berliet, Mesa Laboratories | Explore the Biological Indicator/Bioburden (BI/BB) method for achieving sterilization of products along with the prerequisite studies needed to develop the sterilization process. |
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| Constraints And Solutions For Biopharmaceutical Manufacturing | Article | By Scott Merz, Asahi Kasei Bioprocess | Dissect the reasons for capacity bottlenecks stemming from process development scope, downstream chromatography, and equipment constraints, and delve into the potential solutions associated with each. |
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| How A Top 5 Pharma Realized $20M In Annual Savings | Case Study | Aizon | A top 5 pharma company faced a threat to their flagship product and aimed to enhance profitability despite a high COGS. Learn about the solution that played a key role in overcoming this hurdle. |
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| Elevating Quality Beyond Compliance | Article | By Mike Jovanis, Veeva | See how one company was able to connect its quality processes, improve collaboration across business functions, and address the needs of its digitally-aware workforce. |
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| Smart Softgels: Driving Innovation In Pharma | Article | Douglas CDMO | Learn about how softgels are poised to facilitate innovation in the pharmaceutical industry as well as ongoing advancements in optimizing drug bioavailability through nano formulations. |
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| Does Your CDMO Have Sustainable API And RSM Strategies? | Article | By Scott Martin, Grace Fine Chemical Manufacturing Services | How can you be sure the CDMO you select has appropriate oversight and management of their RSM and API manufacturing supply chain, so you do not experience costly delays? |
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| A Robust Extractables Data Package Helps Drive Patient Safety | Article | By Will Parker, West Pharmaceutical Services, Inc. | Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product. |
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By Aashi Mishra, Research Nester | Peptide synthesis is used to create new vaccines, medications, and enzymes. This article provides an overview of solid phase and liquid phase synthesis as well as new market research. |
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