Production Featured Articles

  1. Sterility Assurance: The Fundamentals 10/8/2024

    Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

  2. Expert Voices: Why Aren't QC Labs Fully Automated Yet? 10/4/2024

    Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

  3. How Digital Twins Are Redefining Biotech Production And Labor 10/1/2024

    Digital Twins are revolutionizing biotechnology by optimizing production processes, enhancing quality control, and changing the workforce. They offer efficiency, predictive maintenance, and compliance benefits.

  4. Innovative Octet® Biolayer Interferometry (BLI) Approach For Non-Disruptive And Fast AAV Capsid Ratio Determination In Complex Biological Matrices 9/27/2024

    Learn about a biosensor that was designed to provide the rapid, real-time, high-throughput measurement of AAV capsid titer in samples throughout the AAV workflow.

  5. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

  6. Strategic API Sourcing: Offshoring Vs. Nearshoring For A Resilient Supply Chain 9/25/2024

    Generic drug manufacturers must carefully consider the decision to offshore or nearshore API sourcing. It's not only about managing costs but also about ensuring a stable and reliable supply.

  7. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals 9/11/2024

    The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.

  8. Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR 9/4/2024

    Content uniformity is one of the most important release criteria for solid dosage forms. In continuous manufacturing, what process analytical technologies (PAT) are available to measure and assure content uniformity as part of a real time release (RTR) strategy?

  9. EMA Issues New Draft Guideline: Chemistry Of Active Substances 9/3/2024

    The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

  10. Industry Insights In Isolator Technologies And Aseptic Processing In Pharma 8/30/2024

    Explore an overview of trends and insights in isolator technologies and aseptic processing in the pharmaceutical industry.