Industry Insights

  1. Choosing The Right Single-Use Bioreactor Platform

    When selecting a bioreactor, It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.

  2. Prepare For An FDA Bioburden Inspection

    A former FDA Biologics License Application reviewer and inspector focusing on microbiology, shares expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.

  3. Changing Column Packing In Chromatography From An Art Into A Science

    The most demanding operation in production scale chromatography is typically packing the column in a way that ensures first time success and a validation result which meets the batch record standards.

  4. Modular Approaches For Diverse Molecules: Reinventing Smart Bioprocessing

    Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.

  5. Making Next Generation Manufacturing Work In Bioprocessing

    When it comes to downstream bioprocessing, we already have many of the technologies we require – we only need to focus on adapting them.

  6. Critical Opportunity For Pharmaceutical And Process Understanding

    Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving pharma to improve product and process quality and efficiency.

  7. CELL & GENE THERAPIES: A GUIDE TO SINGLE-USE CONNECTIONS - 10 Transferable Lessons From The Bioprocessing Industry

    This article captures high-level learning about the use of SUTs in biopharmaceutical manufacturing that can be applied to CGTs, with a special focus on connection technologies.

  8. The Next Generation Of Bioprocess Engineering: Bringing A Perspective From The Last Two Decades

    The increasing complexity of bioprocess engineering has driven a shift toward cell biology and away from process engineering.  Cell types have become more diverse, the science more complex, and genetic modifications more common, all while products are becoming more targeted and cost effective.   What should we expect to see from industry and academia to keep the field moving forward?

  9. Is Selecting A CDMO Based On Contract Price Really Saving You Money?

    Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.

  10. Protecting Against Contamination When Filling Cytostatic Drugs

    Cytostatic agents are used to treat cancer and autoimmune diseases and are among the most complex and delicate drugs. Regarding production and handling, the highest quality requirements apply.