Industry Insights

  1. Sanofi Asks — Will Standardization Take End User & Supplier Relationships To The Next Level?

    A larger scale adoption of SUT may continue to be delayed as biopharmaceutical manufacturers must have access to a reliable supply chain that allows us to successfully deliver product to our customers.

  2. Pharmaceutical Primary Packaging Strategies

    There are several factors that biopharmaceutical companies should take into account when considering outsourcing primary packaging. This article provides an in-depth look at the benefits of developing packaging strategies as early as possible in the drug development process, how primary packaging should be approached to ensure patient compliance, and different forms of packaging that best protect and improve the stability of a product.

  3. Reducing Upstream Processing Scale-Up Risks Using QbD

    Upstream processes must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance.

  4. 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.

  5. Fermentation And Cell Culture: Bringing The Basics To The Fore

    Fermentation and cell culture can be carried out in batch or continuous processes.  Reminding ourselves of the basics is vital for the development of more cost-effective and efficient biotech production processes. This article reviews those basics to understand the methods best suited for your development.

  6. Don't Be A Daredevil When Retrofitting Your Facility

    With mergers/acquisitions and cost-cutting initiatives, facilities are being shut down and product lines consolidated into existing facilities—risking sub-optimal layout and design.

  7. Future-Proofing Your Single-Use Biomanufacturing Capacity

    The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.

  8. Patient-Centric Drug Design — A Clinical And Academic Perspective

    Most issues in pediatric drug development arise from the fact that drugs are traditionally developed for adults and not children. Dr. Meyers shares the hurdles and  improvements in pediatric drug development.

  9. Cost Savings And Speed: The Untapped Value Of A Single-Source Solution

    Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.

  10. Phase II And Phase III Studies Standard Protocol A Template For Success?

    The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.