Industry Insights

  1. Risk Tool Selection With ICH Q9(R1) In Mind 9/19/2023

    This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

  2. On the Path to Accessible Cell Therapies: Overcoming Current Challenges 8/23/2021

    Control must be maintained throughout all aspects of the supply chain, beginning with manufacturing all the way through to the administration of the product to the patient.

  3. TMT Labeling For Optimized Sample Preparation In Quantitative Proteomics 5/13/2025

    Leverage the power of Tandem Mass Tags (TMT) quantitative proteomics to gain deep insights into cellular dynamics, disease mechanisms, and drug targeting.

  4. Early Development Considerations For Late-Stage NCE Success – Part Two 1/18/2024

    Discover how strategic partnerships, robust process development, and a keen awareness of supply chain vulnerabilities can pave the way to a successful clinical trial.

  5. De-Risking A Bioconjugate's Development Path From Discovery To Clinic

    Understanding the obstacles you may face during bioconjugate development, as well as the tools available to help overcome them, can help streamline your product’s path to market.

  6. Building Biopharma Resilience In Developing Gene Therapies 3/21/2024

    Learn about the opportunities and challenges surrounding gene therapies, the importance of collaboration between biopharma startups and academia, difficulties with the talent pipeline, and more.

  7. Best Practices For Sterile Fill Operator Gowning Training 4/17/2023

    Sterile fill operators are crucial in ensuring pharmaceutical products are contaminant-free and safe for use. Explore best practices for sterile fill operator gowning training, mobile cleanroom benefits, and more.

  8. Self-Injection Of Biologics Made Easy 6/17/2022

    Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.

  9. Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety 7/23/2025

    Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.

  10. Cell & Gene Therapy Bioprocessing: Demand For Better Process Control, Expertise & CMOs 5/14/2021

    Manufacturing capacity for both cell therapies and gene therapy viral vectors remains in short supply. From BioPlan Associates, Inc.'s new survey of biopharmaceutical manufacturing professionals, there is a current and worsening capacity crunch. The industry continues to demand innovative solutions from its suppliers in key areas that can be slow to develop.