Featured Bioprocessing Editorial

  1. Biosimilars Pipeline Shows Remarkable, Sustained Growth

    The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved. This article reviews the current biosimilars development pipeline and progress. 

  2. Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit

    It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

  3. FDA’s DSCSA Pilot Project Program — Should You Participate?

    The FDA announced its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.” The question for the industry is, should you participate in the pilot program?

  4. Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis

    When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.

  5. Big Data And AI In Pharma Development And Manufacturing: An Inside Look

    Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.

  6. Bridging Chasms In Equipment Qualification And Software Validation

    Equipment qualification seems like a straightforward process. However, things usually go awry when gathering a validation team and defining and documenting the intended use and system requirements. 

  7. FDA Approval Of The First nr-AxSpA Biologics: Projecting Regulatory & Market Dynamics

    Although we expect the FDA approval of therapies for non-radiographic axial spondyloarthritis (nr-AxSpA) to be an important event in the coming year, questions remain about the U.S. market potential. Because three therapies are expected to be approved within a similar timeframe, any first-to-market advantage may be limited.

  8. Recalibrating The Supply Chain For Allogeneic Cell Therapies

    In November 2018, I wrote an article about establishing a supply chain for autologous cell therapies — those formulated using a patient’s own cells. This partner piece highlights considerations that need to be taken into account when developing a commercialization and supply chain strategy for allogeneic cell therapies.

  9. Solving Problems More Effectively Than Sherlock Holmes: The Contradiction Matrix

    This is the fourth article in a five-part series on better investigation and problem-solving methods and principles in the life sciences. In writing this one, I’ve been thinking quite a bit about Sherlock Holmes. Not only his exquisite methods, but also flaws in the metacognition and metaphilosophy about how the fictitious detective underwent his work.

  10. Why Data Integrity Is Impossible Without A Quality Culture

    For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”