Biosimilar Manufacturing solution center

1. What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI 11/4/2026

   The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.

2. How Is Your Glass Supplier Adapting To Europe's Energy Crisis? 11/3/2026

   Europe's glass manufacturers, including those making pharmaceutical lab glassware, have experienced a series of energy shocks. Many have adopted sustainability practices.

3. Is Your Supply Chain Ready For The End Of Class VI? 10/21/2026

   Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

4. When Lyophilization Fails At Scale, First Scrutinize Your Formulation 10/16/2026

   When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.

5. The 5 Shifts That Could Remake Lyophilization By 2040 10/15/2026

   Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.

6. Your 7 Decisions To Make Before MES Configuration 10/7/2026

   Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

7. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

   By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

8. Qualification And Validation Of Depyrogenation Tunnels And Autoclaves 10/2/2026

   Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

9. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

   The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

10. Characterization Of PFAS Extractables In Gas Filtration Devices 9/29/2026

    Understand how fluorinated membrane chemistries in sterilizing grade gas filters may introduce PFAS risks, and how extractables testing can support contamination control strategies.