Industry Insights

  1. Biofabrication And Cell Therapy: Where We Are (And Where We're Going) 1/14/2022

    Cell therapy and regenerative medicine has greatly benefited from biofabricating has been cell therapy and regenerative medicine and there are opportunities in this next frontier which could someday make whole-organ bioprocess engineering.

  2. FMEA Vs. System Risk Structures (SRS): Which Is More Useful? 9/24/2021

    In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?

  3. Dry Powdered Medium Milling Equivalency Study 9/26/2022

    An assessment of the physical, chemical, and biological characteristics of representative complex media and feeds was made to compare pin mills and overall dry powdered medium manufacturing processes.

  4. Considerations For Successful Upstream Manufacturing Process Scale-Up

    A CDMO’s ability to scale seamlessly between bioreactor sizes is critical when adopting a client’s manufacturing process.

  5. Can Real-World Evidence Transform Healthcare? FDA Indicates Yes 11/19/2021

    Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.

  6. Principles And Concepts Of System Risk Structures For Understanding & Managing Risks 12/6/2021

    A truly effective risk analysis method for the biopharma industry should provide insights to and understanding of the fundamental properties and attributes that underlie every type of risk. This article describes how system risk structures (SRS) can be used to understand and manage both simple risk situations as well as complex risk landscapes quickly and efficiently.

  7. Regulatory Expertise And CMC Document Preparation To Support mRNA-Based Therapeutic Development 10/7/2024

    Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.

  8. Gamma Irradiation: Risk-Based Approach To Sterility In Single-Use Systems 4/7/2022

    Understand the difference between a validated sterile claim and a low or zero bioburden microbial control claim on single-use systems and where each fit into biopharmaceutical manufacturing processes.

  9. Cell Suspension Or Adherent Cell Surface: Which Method Is Right For Your Lab? 6/8/2022

    We review what to consider when selecting an adherent or a suspension platform for your cell culture method to achieve the best growing conditions.

  10. ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices 9/28/2020

    This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.