Guest Columns

31. FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs 12/11/2025

    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.

32. Four Reasons You Should Choose Lyophilization for Your Next Project 12/10/2025

    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.

33. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

    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.

34. TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration 12/8/2025

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

35. Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up 12/5/2025

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

36. Strained Manufacturing, Complexity Stymie In Vivo Progress 12/4/2025

     Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.

37. To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem 12/4/2025

    The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.

38. Ask The Pros — The Latest In HCP Monitoring 12/4/2025

    Established methods focused on counting all HCPs indiscriminately. Now, a new wave of sophisticated monitoring offers clearer impurity profiles.

39. Formulation And Delivery Considerations For Cell And Gene Therapies 11/25/2025

    How can we ensure cell and gene therapies are truly transformative for patients? Success depends on the right combination of formulation, preparation, and delivery.

40. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

    The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.