GUEST COLUMNISTS

• Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing

  How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?

• What 2025 FDA Warning Letters Tell Us About GMP Compliance

  This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

• The Module Type Package Wants All Your Equipment To Start Talking

  A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

• FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs

  The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.

• Four Reasons You Should Choose Lyophilization for Your Next Project

  Lyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.

• Why Your MVP And Its Evolution Matters To Manufacturing

  Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

• TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration

  When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.

• Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up

  Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.