Featured Articles

1. Simulating PUPSIT Or Gas Purges In Bacterial Challenge Tests 5/22/2026

   Managing PUPSIT‑related risks is a critical part of contamination control. Learn how bacterial retention studies, wetting fluids, and downstream practices influence sterility assurance.

2. Product-Wet Integrity Testing: Risk-Based Strategies 5/22/2026

   When standard water‑based integrity testing falls short, product‑wet approaches can offer a more representative alternative. Learn how risk‑based strategies are used to establish reliable test limits.

3. FDA's New Flexible CMC Framework For CGT 4/14/2026

   The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

4. Comparing Process Development Approaches For Recombinant Proteins 2/26/2026

   Explore how adding a traceless tag enables streamlined affinity purification for recombinant proteins, and how this approach compares with a conventional process in development time, recovery, and purity.

5. Host Cell Protein (HCP) Removal Post Virus Inactivation In mAb Processing 2/26/2026

   Clarifying post–virus inactivation streams with a charged depth filter can remove precipitates while significantly reducing HCPs. See how a dual‑layer filtration approach supports stronger impurity control.

6. Sterile Injectables: Why Innovation Matters More Than Ever 1/15/2026

   New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.

7. Key Topics And Trends In Aseptic Filling 1/9/2026

   Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.

8. Aseptic Process Design And Simulation Under Annex 1 Guidelines 1/9/2026

   Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.

9. Accelerate GMP Certification With Annex 1-Compliant Aseptic Automation 1/9/2026

   Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.

10. Advanced Therapies Going Mainstream: Are We There Yet? 11/14/2025

    Advanced therapies are nearing mainstream adoption, with cell, mRNA, and oligonucleotide treatments expanding into broader indications. Learn what’s driving this shift and what manufacturers must do.