Industry Insights

  1. How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much 7/21/2025

    In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.

  2. NIST, IBBR Researchers Explore Excipient-Influenced mAb Dynamics At Atomic Level 8/16/2024

    Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations.

  3. Fine-tuning Analytical Development Strategies For Every Phase 3/22/2024

    Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

  4. Optimizing Tablets For Even Splitting: The Pressure Sensitive Bisect Design 11/11/2024

    The pressure-sensitive bisect design allows accurate tablet splitting by maximizing facet width, optimizing angles, and balancing radius values for durability and user-friendly administration.

  5. Mitigate C&G Therapy Manufacturing Risks Amplified By COVID-19 5/19/2022

    Understanding not only the limitations of a post-COVID manufacturing landscape, but also developing strategies to help overcome these challenges is critical to driving the future of next-generation CGTs.

  6. Rare Diseases' Cost Burden On Patients 4/13/2022

    95% of rare diseases do not have approved treatments or therapies. Patients often bear the brunt of costs directly and indirectly. By understanding the cost drivers that a lack of available treatments poses for rare disease patients, pharma companies can identify unmet needs. Drug developers can improve the cost burden using 3 strategies.

  7. An Update On 2020 U.S. Biosimilars Regulation & Litigation 9/1/2020

    The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.

  8. FDA's December 2012 Guidance On IND And BA/BE Reporting - Part II 1/22/2013

    Continuing with the review of the key points in FDA’s guidance.  This is the second of three postings. By Bart Cobert

  9. Meeting The Growing Demand For Pre-Filled Syringes 3/7/2023

    The market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.

  10. Mammalian Biomanufacturing Industry Supply & Demand Trends 10/26/2020

    While capacity will increase over the next five years, demand for capacity, pandemic aside, will increase at a slightly faster rate, allowing for some short-term loosening of capacity constraints, but after 2024, capacity tightening may occur.