Industry Insights

  1. Economic, Operational Advantages Of SaaS For Life Sciences Manufacturing 6/25/2020

    Over the past decade, Software-as-a-Service has reduced TCO by 77% compared to on-premise apps. SaaS providers now offer systems designed to meet the needs of FDA-regulated companies.

  2. Heightened Standards For Satisfying Written Description In Pharma Patents 7/27/2022

    In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.

  3. Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility 4/8/2022

    As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.

  4. 3 Reasons Life Sciences Should Adopt A Data-Centric Quality Mindset 2/16/2022

    So few are poised to adopt a data-centric approach by using digitization, analytics, and AI that those who do will reap benefits from the data in their now unstructured documents.

  5. Why GMP AI Is Poised To Boom In 2025 2/7/2025

    Gain insights into why 2025 is set to be a transformative year for AI in the pharmaceutical industry, driven by regulatory clarity, technological advancements, and growing industry adoption.

  6. How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing 2/27/2024

    To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts. 

  7. FDA Gives More Time To Comply With Certain DSCSA Requirements 9/27/2023

    To the relief of pharmaceutical companies and their trading partners, the FDA has paused enforcement of some Drug Supply Chain Security Act requirements. The agency warns that it's not an excuse to delay compliance.

  8. Continuous Processing For Enhanced Monoclonal Antibody Production 9/14/2023

    mAbs have only recently been leveraged for advanced bioprocessing techniques. Explore highlights from a webinar where experts discussed their unique collaboration for the continuous processing of mAbs.

  9. These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. 7/30/2021

    Recently appointed to the permanent CDER director role, Dr. Cavazzoni’s appointment was not unexpected, as she was recruited to join the FDA in 2018 from a senior industry role and served as acting CDER director at the start of the agency’s pandemic response. Her experience suggests she will continue to evolve – rather than revolutionize – FDA’s drug review policies.

  10. Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

    This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.