Industry Insights

  1. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

    AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

  2. The New Clinical Packaging Paradigm: Differentiation And Decentralization 7/8/2025

    The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?

  3. Innovative Platforms For Improved Viral Vector Development And Scale-Up 6/21/2023

    The challenges to developing AAVs or LVs necessitate expertise in productivity improvements, cell line development, CMC strategy, and platform optimization, among other variables.

  4. Increase Agility By Integrating Drug Substance And Drug Product 1/9/2026

    Biopharma success depends on agility. Move efficiently from discovery to delivery by co-locating drug substance and drug product operations, reducing transfer risks and accelerating your timeline

  5. PIC/S Annex Update: What Is Your ATMP Control Strategy? 6/30/2021

    Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in. 

  6. Improve Solubility And Spray Drying Throughput For Brick Dust Compounds

    This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

  7. 5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals 7/2/2021

    Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation. 

  8. A New Reality In Life Sciences 2/14/2024

    Gain insight from this author's experience with virtual reality (VR) and the specific benefits of VR in scientific contexts.

  9. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

  10. Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide 2/5/2025

    Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.