Industry Insights

  1. Picking The Best Virus Sample Prep Method In Process Development 1/26/2024

    Optimizing downstream operations in viral vaccine development starts with characterization. Learn strategies for picking the best sample prep method.

  2. The Rise Of HPAPI Molecules

    A growing proportion of the drug development pipeline is made up of more complex, highly potent APIs (HPAPI). Explore trends in highly potent API manufacturing: safe handling, containment and production.

  3. Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing 12/15/2025

    How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?

  4. Addressing Residual Host Cell DNA Contamination Challenges 2/22/2023

    Learn how to meet regulatory standards for cell and gene therapy products with absolute quantification and sizing of HEK293 residual DNA.

  5. Cleanroom Data Analytics For Setting Up Environmental Monitoring 6/24/2025

    Discover how digital integration enhances compliance, streamlines operations, and enables proactive planning for contamination control in pharmaceutical manufacturing

  6. 6 Questions To Ask Your Fluid Management Component Supplier 12/19/2023

    To ensure you receive the best and safest single-use components, evaluate your fluid management supplier by asking these six questions.

  7. Keys To Successful Blinded Labeling 11/15/2022

    The content and creation of blinded labels are tightly regulated and benefit from the guidance of an experienced partner.

  8. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

    The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

  9. 4 Reasons Your Startup Should Implement QMS 3/30/2023

    Explore four reasons why your medtech startups is ready to implement quality management system and move into a new digital age.

  10. Embracing Robotics To Scale Cell And Gene Therapy Manufacturing 3/1/2023

    This article explains the robotics landscape, the difference between automation and robotics, as well as three steps to introduce robotics into your cell and gene therapy business.