Newsletter | March 9, 2023

03.09.23 -- FDA, FTC Collaborate To Advance Biologics Competition
 
Featured Editorial
4 Focus Areas To Modernize Your Cleaning Validation Strategy
 
By Bilel Khedir, Opalia Pharma Recordati Group

The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.
After Decades Of Biomanufacturing Workforce Development, What’s Next?
 
By Kamal Rashid, Ph.D., International Biotechnology Associates

We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.
Industry Insights
Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems
Article | West Pharmaceutical Services, Inc.

Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.
Regulatory Considerations For Alternative Microbial Methods
White Paper | MilliporeSigma Biosafety Testing Services

This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.
Wearable Injectors: An Alternative To Traditional Intravenous Administration
Infographic | BD Medical - Pharmaceutical Systems

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.
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Biacore SPR System Fact Or Fiction Series
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