Industry Insights

31. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

32. How Digital Twins And Hybrid Modelling Optimize Cell Culture Process For Better Production 7/14/2025

    Discover how digital twins are enabling the optimization of cell culture processes for improved, more predictable outcomes in the creation of therapeutic proteins and antibodies.

33. Leveraging AI To Build Process Intelligence And Streamline Drug Development 4/4/2025

    Accelerate drug development with AI. Enhance process intelligence and achieve gold-standard data sets with the right digital tools and improved maturity.

34. Real-Time Visibility In Pharmaceutical Manufacturing: Needs & Solutions 6/21/2022

    We take a deep dive into real-time visibility and consider the top needs faced by three major players in pharma manufacturing: quality assurance, supervisors, and operators.

35. How Compounding Pharmacies Are Combating FDA Drug Shortages 9/26/2024

    Explore the global impact of pharmacy compounding, which plays a critical role in mitigating drug shortages and providing personalized medication solutions when commercial drugs are unavailable.

36. Stages 2 And 3 QbD Validation Strategies For Nonsterile Solid Dosage Forms 4/11/2013

    In my previous communication in February, I provided an overview of stage 1 QbD validation strategies for process design for nonsterile solid dosage forms. In this article, I will continue to highlight strategies for validation prior to release of a commercial product (stages 2 and 3).

37. The Chemistry Of Aqueous Cleaning 4/26/2023

    In this chapter of The Aqueous Cleaning Handbook, we explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.

38. Low Temperature Storage Containment For Vial And Syringe Systems 6/20/2025

    With the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.

39. How To Evaluate CDMO Communication: A Framework For Biotechs 10/16/2025

    Evaluate a CDMO's communication by assessing access, transparency, responsiveness, and scalability. Use a framework to ensure your partner builds a strong relationship that endures through any challenge.

40. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

    The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.