Newsletter | February 9, 2023

02.09.23 -- First Humira Biosimilar Now Available In U.S.
 
Featured Editorial
Will ESG Be 2023’s Hottest Business Topic In Biopharma?
 
By Lil Read, GlobalData

Sustainability used to be just about saving the planet. Today it has morphed into an umbrella term for environmental, social, and governance (ESG) issues. Mentions of ESG and related topics in pharma companies’ filings more than tripled between 2016 and 2021. What are the commitments that companies are making, and which Big Pharma companies are making those commitments?
FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections
 
By Mark Durivage, Quality Systems Compliance LLC

The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.
Industry Insights
Is Your Biologic At Risk For Protein Aggregation? Part 2
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne

The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologic drugs. We offer steps you can take to help prevent aggregation.
Viral Clearance: Something Went Wrong, What Do I Do Now?
Webinar | MilliporeSigma Biosafety Testing Services

Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Learn how to troubleshoot these and manufacturing deviations that impact viral safety.
Placing Drug Strategies On A Solid Foundation For Success
White Paper | Pfizer CentreOne

Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.
News Headlines
Solutions
Can You Run Crude Samples Using An SPR Instrument?
Cytiva
De-Risk Container-Closure Selection: DeltaCube Modeling Platform
West Pharmaceutical Services, Inc.
BD Vystra Disposable Pen For The Self-Injection Of Chronic Disease Medications
BD Medical - Pharmaceutical Systems
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