Featured Bioprocessing Editorial

  1. Are We Adequately Assessing U.S. Pharma Supply Chain Risks? 6/26/2020

    There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.

  2. Key Engineering & Facility Considerations For Liposome Manufacturing 6/24/2020

    This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so.

  3. Old Drug, New Tricks: Will The BPCIA Drive Generic Competition For Insulins? 6/23/2020

    High demand, few suppliers, and soaring prices point to the need for more generic competition in the insulin market. This article discusses recent changes to the legal and regulatory framework governing insulin approval that might facilitate such entry.

  4. Top 5 Mistakes To Avoid When Measuring Overall Equipment Effectiveness 6/22/2020

    Despite its (apparently) trivial formulation, overall equipment effectiveness (OEE) is one of the most misleading key performance indicators ever used in the manufacturing world. This article examines five common mistakes you'll want to avoid when dealing with OEE.

  5. 4 Preparatory Moves For A Post-COVID World 6/19/2020

    While we don’t know how different the post-COVID world will be, we do know that pharma and medtech leaders are looking ahead and planning to work differently.

  6. Merck, Walmart, IBM, & KPMG’s FDA Blockchain Pilot: What We Learned 6/17/2020

    IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S. 

  7. A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided 6/15/2020

    Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?

  8. What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks 6/12/2020

    This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.

  9. An Introduction To Liposome Processing For Drug Delivery 6/10/2020

    On Monday, Bioprocess With The Bozenhardts will take a deep dive into the return of the liposome. In the meantime, this column digs into why the liposome's biocompatibility and well-understood chemistry of encapsulation of a wide variety of APIs make it a compelling delivery mechanism.

  10. After COVID-19: Time To Rethink, Redesign, & Reprioritize Everything 6/8/2020

    As we navigate the uncertainty ahead, two things are certain: 1) We will get through this, and (2) the post COVID-19 environment will be very different — but will it be better?