Industry Insights

31. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.

32. FDA Gives More Time To Comply With Certain DSCSA Requirements 9/27/2023

    To the relief of pharmaceutical companies and their trading partners, the FDA has paused enforcement of some Drug Supply Chain Security Act requirements. The agency warns that it's not an excuse to delay compliance.

33. How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing 2/27/2024

    To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts. 

34. The Promise Of Gene Silencing: A Primer On siRNA 8/5/2022

    Small interfering RNAs (siRNAs) are short sequences of RNA that interfere with gene expression, reducing or eliminating the expression of a disease-related protein by targeting its corresponding mRNA. siRNAs could treat a wide array of diseases. How does it differ from other therapeutic modalities such as gene therapy and gene editing?

35. COVID-19's Impact On Availability Of Drugs And API From India And China 4/23/2020

    COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.

36. Resolving Common Single-Use Concerns 2/7/2023

    Demand for single-use production tools, components, expertise, and capabilities continues to grow as innovative cell therapies evolve. However, concerns and misconceptions abound regarding single-use solutions.

37. A Versatile Analytical Approach To Cleaning Validation For Multiple Linker–Payload ADC Platforms 3/26/2026

    Antibody–drug conjugates combine monoclonal antibodies, linkers, and potent cytotoxins, requiring highly sensitive analytics, stringent cleaning validation, and flexible platforms to manage manufacturing complexity and contamination risks.

38. Utilizing Multiplex ddPCR To Streamline Viral Gene Therapy Workflows

    Analytical technologies like Droplet Digital PCR (ddPCR) provide a more rapid and robust approach to nucleic acid quantification for better sensitivity, accuracy, and precision in therapeutic development.

39. Reliable Components For The Lifecycle Of Your Injectable Drug Product

    As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.

40. Do's And Don'ts Of Material Handling When Retrofitting For ADCs 1/20/2026

    Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.