Biosimilar Manufacturing solution center

  1. 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.

  2. 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.

  3. 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.

  4. 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. 

  5. 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.

  6. 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.

  7. High-Performing Ionizable Lipids For Controlled Nucleic Acid Delivery 9/29/2026

    Ionizable lipids are central to effective mRNA delivery, influencing potency, biodistribution, and toxicity. See why advancing delivery beyond the liver will require stronger structure-function insights.

  8. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  9. Transforming Gene Therapy With A Scalable Platform Solution 9/15/2026

    Discover how a platform approach to AAV manufacturing can reduce development time and cost, as well as how optimized processes enable reliable production and scalable implementation in bioreactors.

  10. 6 Modeling Approaches That Make Complex Bioprocess Data Useful 9/14/2026

    AI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.