Guest Columns

  1. Building Frameworks To Support Complex Therapy Manufacturing 1/16/2025

    To make its clinical product, CLBR001+SWI019, the Calibr-Skaggs Institute for Innovative Medicines relies on a complex network of contractors from around the globe.

  2. New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings 1/15/2025

    To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

  3. Host Cell DNA Impurities: A Unique Challenge For rAAV 1/10/2025

    The potential safety impact of residual hcDNA remains largely unknown, but researchers at UCB are investigating to learn more and mitigate if necessary.

  4. Tune Therapeutics' 2025 Epigenome Editing Outlook 1/10/2025

    Chief Scientific Officer Derek Jantz talks about recent key innovations in gene therapy and RNA technology while considering what milestones we might see in 2025.

  5. CTMC's 2025 Cell Therapy Manufacturing Outlook 1/10/2025

    CEO Jason Bock looks back on milestones of 2024, namely an approved TIL for melanoma, and explains how it sets the stage for this year.

  6. Hear Me Out — Cell Therapy GMP Starts With The Donor 1/9/2025

    Regulators also have indicated they expect allogeneic cell therapy donors to meet more rigid eligibility requirements and undergo screening.

  7. A Justification For Using In-Process Controls In Place Of Cleaning Validation 1/9/2025

    This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.

  8. 7 Focus Areas To Establish A Win-Win Relationship With Your CDMO 1/7/2025

    Working with a CDMO doesn’t always go as planned. This article outlines the factors that will impact project success and set up a “win-win” relationship.

  9. Deploy AI To Become A cGMP 'Special Agent' With A License To Care 1/7/2025

    Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."

  10. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.