Guest Columns

  1. Building AAV Manufacturing Capacity For Large Patient Diseases 11/15/2023

    AAV-based gene therapies are poised to treat larger patient populations with diseases like cardiovascular and neurological conditions. But scaling poses safety and manufacturing challenges. This deep dive into the issues, using could help

  2. Modular And Single-use Tech Driving The Future Of Biomanufacturing 11/14/2023

    BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.

  3. Your Local Affiliates Want More From Your Global Regulatory Information Management 11/9/2023

    Achieving regulatory excellence depends on a combination of process optimization, effective global systems, high data quality, and better local affiliate collaboration. This article shares key takeaways from new survey results from local offices/affiliates representing 94 countries.

  4. What Regenerative Medicine Manufacturers Have Been Waiting For 11/9/2023

    It's not revolutionary, say two FDA experts. However, the agency's new voluntary consensus standards program for regenerative medicine therapies responds to an industry clamoring for standardization. With standards that everyone agrees on, sponsors can save massive amounts of time designing protocols, and regulators can save time reviewing them.

  5. In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist? 11/8/2023

    Over the years, we have seen the progression of the biologics contract services go from contract manufacturing organizations (CMO) to what this expert today calls the C(x)DMO: the contract analytical/research/testing development manufacturing organization. Focusing on the mammalian biologics segment, this expert analyzed public information and a proprietary database by looking at 80 service providers supporting projects ranging from early discovery to commercial manufacturing. 

  6. Strategies For Today’s Top Quality & Regulatory Outsourcing Challenges 11/6/2023

    Recently, Outsourced Pharma hosted and moderated a Live! event on today's pressing quality and regulatory outsourcing challenges. Outsourced Pharma Chief Editor Louis Garguilo moderated and was joined by Karla Knower, Paradigm Biopharmaceuticals; Christine Feaster, Quality Executive Partners; Bikash Chatterjee, Pharmatech Associates; and Erin O'Brien, Biogen. This article shares the highlights from that panel discussion.

  7. Human Performance Theories And SOPs: Human Error Prevention In Manufacturing 11/3/2023

    Standard operating procedures (SOPs) are often viewed as mere documents to be followed, rather than as dynamic tools. Drawing on human performance theories, this article explores how to create, review, and train on SOPs, as well as how manufacturing and quality teams can collaborate to improve oversight, all with human error prevention in mind.

  8. New Developments In mRNA Vaccine Efficacy Show Promise 11/1/2023

    Significant caveats with the current base modification approach for mRNA vaccines still remain and need to be addressed. This article looks at activation of innate immunity, overcoming the limitations of pseudouridine, novel 3-base oligonucleotides, and more.

  9. Understanding The Importance Of Real-time Monitoring For Protein Aggregation 10/30/2023

    BioSolution’s Danny Chou, Ph.D., Pharm.D., breaks down the advantages of real-time monitoring for protein therapeutics, including how these approaches can accelerate timelines, produce better data, and smooth regulatory compliance.

  10. 1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next 10/30/2023

    The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until Nov. 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.