Industry Insights

  1. Choosing The Optimal Biopharmaceutical Cold Storage Solution 9/26/2024

    Choosing the right cold storage freezer can be challenging. High storage density, modular shelving, and controlled temperature are a few key considerations for superior long-term cold storage.

  2. Key Trends And Developments In Injectable Drug Formulation And Delivery

    As the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.

  3. Digitalization In HPAPI Development & Manufacturing

    A rapidly growing toolbox of digital technologies can be applied in many areas of both process development and production, which may help accelerate improvements in HPAPI production.

  4. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

  5. Unpacking Pfizer's Advanced Process Control Platform For Upstream Ops 8/29/2025

    Pfizer's advanced process control platform gives modelers more dexterity compared to default controllers, thus speeding up process development.

  6. Supporting The Unique Needs Of Your Sterile Injectable

    Leveraging the experience and specialized technology of a reliable CDMO partner is essential to ensure your sterile injectable therapeutic's safety and quality while delivering at speed.

  7. Prepared For Impending Changes To U.S. Biologics & Biosimilars Law? 1/16/2020

    Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

  8. Scalability And Productivity Of Transient Transfection AAV Production 9/30/2024

    By refining variables such as starting DNA, reagents, cell density, and media composition, organizations can improve rAAV process efficiency and scalability.

  9. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

    The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

  10. How Particle Counting Efficiency Affects Distribution Data 6/24/2025

    Examine how counting efficiency and resolution impact data interpretation in critical environments like cleanrooms and pharmaceuticals.