Industry Insights

  1. 4 Risk Mitigation Strategies For mRNA Production 4/17/2023

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  2. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

    The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

  3. A Guide To Polishing Chromatography In Process Development 2/6/2023

    Polishing chromatography describes the removal of minute amounts of impurities in the final phase of biopharmaceutical manufacturing. Explore considerations in developing your polishing steps.

  4. Following The Science To Develop Best-In-Class Cancer Drugs 12/11/2023

    As innovative cancer therapeutics continue to enter the clinical trial pipeline, some developers are shifting their focus toward developing drugs that are safe and efficacious with minimal toxicity.

  5. Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach 11/14/2025

    Here's a blueprint for transforming the fragmented, high-risk interface between vector and cell therapy platforms into a unified, predictable, and compliant system.

  6. Unleashing The Potential Of iPSC-Based Allogeneic Cell Therapy 10/4/2023

    Learn how the use of human PSCs as starting materials for cell therapies is shifting and the potential PSCs hold to reduce cell variability and costs associated with cell line development.

  7. A Roadmap For Navigating Biologic Development 1/21/2026

    A phase‑appropriate roadmap guides biologics from early formulation to commercialization through Quality by Design, strong analytics, stability optimization, and regulatory alignment.

  8. Key Considerations For cGMP Building Conversions 3/16/2022

    As the life sciences workforce has increased, companies need more space to accommodate them. One emerging option is searching for buildings such as offices and warehouses and converting them into biopharma manufacturing facilities. However, not all conversion projects are as easy as you would hope. This article shares key considerations for such a project.

  9. Bioprocessing Hiring And Capacity Crunch On The Horizon 5/21/2020

    With a very healthy R&D pipeline of cell and gene therapies, we can expect multiple blockbuster products and various “orphan” niche products to be launched annually in coming years. As a result, the industry is heading for a capacity crunch.

  10. Tales From The Trenches: Developing Potency Assays Outside Big Pharma 7/18/2025

    Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.