BIO From The Editor and Guest Columns

  1. AbbVie’s Dr. Howard Jacob: Improving The Drug Pipeline With Genomics
    8/21/2019

    The relationship between therapies and genetic composition is incredibly important to the future of medicine, and the way it's manufactured. I sat down to discuss the topic with Dr. Howard Jacob, who's working to improve the drug pipeline at AbbVie using genomics tools.

  2. Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace
    8/19/2019

    From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.

  3. Inside NIIMBL And Its New FDA Partnership
    8/19/2019

    Last month, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware, on behalf of NIIMBL, has entered into a Collaborative Research and Development Agreement (CRADA) with the FDA. Effective July 15, the agreement gave FDA and NIIMBL the ability to “collaborate in a pre-competitive environment to strengthen research, innovation, training, and collaboration in the biopharma manufacturing industry.”

  4. A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    8/14/2019

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

  5. 4 (More) Critical Considerations For Drug Delivery Device Development
    8/12/2019

    Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

  6. What Organizational Design Says About Your Commitment To Data Integrity
    8/8/2019

    Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

  7. Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom
    8/8/2019

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

  8. Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?
    8/7/2019

    Virtual pharmaceutical/biotech companies often receive conflicting advice regarding the need to establish an internal cGMP quality system. Either they’re told “you need an extensive set of cGMP SOPs” or “you don’t need any cGMP SOPs at all.” Which advice is correct?

  9. 4 Important Things To Consider Before Developing A Drug Delivery Device
    8/6/2019

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.

  10. 2019 U.S. State Policy Trends Impacting Pharma Manufacturers
    7/31/2019

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.