Featured Bioprocessing Editorial

  1. Developing A Process Performance Qualification Master Plan For Gene Therapies 4/19/2024

    This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.

  2. What Time Is Best To Bring My CDMO On Board? 4/17/2024

    The answer might be sooner than you think and entail more transparency than you're used to.

  3. Unpacking The Importance Of Lipid Nanoparticle Production Platforms 4/15/2024

    Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.

  4. Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise 4/12/2024

    You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.

  5. FDA Publishes Final Guidance On Reporting Listed Drug Amounts 4/10/2024

    Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.

  6. 2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies 4/9/2024

    Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.

  7. AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance 4/8/2024

    The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

  8. Digitizing CMC Knowledge Management 4/8/2024

    Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.

  9. Managing Supply Chain Risks Using Relational Risk Analysis 4/5/2024

    In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.

  10. 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.