Industry Insights

  1. 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.

  2. Unpacking FDA's New Guidance On Collecting Patient Experience Data 7/28/2020

    The FDA recently released one of what is to be four new guidances providing a general overview of patient-focused drug development. This article summarizes each component of "Guidance 1: Collecting Comprehensive and Representative Input" and details how the guidance may impact sponsors of clinical trials.

  3. How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery 6/17/2022

    With “low-hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.

  4. When Does GMP Matter In Non-GMP Settings? 4/5/2024

    Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

  5. The Benefits Of Mass Spectrometry For Expediting Biologics To Patients

    With increased pressure on CMC development to support shortened BLA submission timelines, mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development.

  6. Tips & Tricks For Risk Facilitators Conducting Remote Sessions 12/8/2021

    When the pandemic hit, the tools normally available to a risk facilitator during a working session were gone. This article presents some of the challenges encountered and learnings from that adjustment and recommends tips for risk facilitators in the hybrid work environment that has emerged from the pandemic.

  7. Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients 10/9/2024

    In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

  8. From Discovery To Commercial Promise With Philogen's Dr. Dario Neri 9/23/2022

    In a recent episode of The Business of Biotech, Philogen CEO Dr. Dario Neri sat down to explore his journey from academia to startups, as well as Philogen's own trajectory.

  9. 5 Key Considerations For Companies Outsourcing Process Development 6/9/2025

    Venture capital in biotech remains strong post-pandemic, especially in cell and gene therapies. Discover five key factors to help companies choose between in-house and outsourced process development strategies.

  10. Insulin's 100-Year History Inspires Today's Biotech Industry 2/22/2023

    Former FDA regulator Jeffrey C. Baker, Ph.D., has been speaking on the history of insulin, the first biologic, at seminars and conferences for years. This year, those talks seem more important as we mark the 100th anniversary of this life-saving drug. Baker says insulin's story holds inspiration for today's biotech companies.