Guest Columns

  1. The Matryoshka Model: The New Face Of Contract Packaging In Pharma 6/4/2025

    Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

  2. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  3. The Latest On CRISPR Deployment In TIL Therapy Development 5/30/2025

    Here’s a quick look at how CRISPR’s emerging as an enhancer to improve TIL pharmacokinetics, efficacy, and tolerability without disrupting production.

  4. Clues To Mapping A Crisis-Ready Tech Transfer Playbook 5/28/2025

    One of the many people behind AstraZeneca's COVID-19 response describes lessons learned during the biggest global health emergency of the modern era.

  5. How To Automate Bioprocesses Without Locking Out Future Upgrades 5/28/2025

    Introducing automation now means you limit your ability to upgrade later. Early attention could give you options when the next generation of technology rolls around.

  6. To Enhance Biotech Investments, Involve CDMOs Early In CMC Decisions 5/26/2025

    In Part 1, we introduced the critical link between CMC and prospective investors and/or licensees. Here we conclude with suggestions for how CDMOs can lend expertise early in discovery/development to improve the probability of securing investment or license for their clients.

  7. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

    The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

  8. Lilly's Calculated Approach To Upgrade Trade-Offs 5/22/2025

    If the disruption of implementing and adapting to new technology costs more than its benefits, teams should proceed cautiously.

  9. How APBio Builds Multispecific Analytical Target Profiles 5/22/2025

    Some attributes require an elevated level of attention, in particular when it comes to analyzing chain pairing, folding fidelity, and aggregation.

  10. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.