Featured Bioprocessing Editorial

  1. Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?

    Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

  2. Critical Considerations In Outsourcing Nanotechnology Drugs

    If the mission statement of nanotechnology is “to perform precise interventions at the cellular or molecular level to improve health and promote quality of life,” then the contract manufacturer might seek a mission statement such as, “to enable novel therapy in a safe, effective way, advancing medical science one medicine at a time.”

  3. Chief Quality Officers: Redesigning Quality For The 21st Century

    With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.

  4. Pharma Industry Braces For A No-Deal Brexit

    Chaos reigns supreme in London at the moment, as British Prime Minister Theresa May struggles to find a graceful way for the United Kingdom to exit from the European Union (EU). Meanwhile, pharmaceutical manufacturers must prepare for multiple potential outcomes, including a “no-deal” (or “hard”) Brexit.

  5. Cryogenic Transport For Gene Therapy Products — The Pros And Cons

    Temperature-controlled packages used for the transport of gene therapy products use a combination of thermal insulators or thermoregulators to decrease the heat transfer rate from outside of the shipper to the inside. In this two-part article, we will explore common methods of temperature-controlled transportation and delve into their pros and cons. In Part 1, we focus on passive cryogenic options.

  6. Biosimilars And The BPCIA: Past, Present, And Future

    While the biosimilar market in the U.S. has gotten off to a relatively slow start compared to Europe, where biosimilars have been available since 2006, it has recently gained momentum and will continue to grow in the coming years as more “blockbuster” biologics lose regulatory exclusivity and patent protection. Here we review our observations in the biosimilar space since the enactment of the 2009 Biologics Price Competition and Innovation Act (BPCIA) and our view of the future of biosimilars and related patent disputes.

  7. FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say

    Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.”  The document describes what a combination product is and how to interact with the FDA when developing a combination product, and it identifies some of the principles the agency uses in determining what type of premarket submission should be made. 

  8. Increasing Biosimilar Competition: Trends In Government Responses

    A variety of stakeholders including the FDA, Congress, and hospitals are in agreement — biosimilars have not penetrated the market as expected. A number of governmental bodies have focused on remedies.

  9. FDA’s First DSCSA Warning Letter — A Closer Look

    The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.

  10. Not Your Grandma’s Aseptic Filling Line: Letting Go Of Tunnels, Washers, And Other Aseptic Vestiges

    We often work with organizations adding capacity, transferring new products, and adding existing products from other sites into their “preferred” plants. In each case, the receiving site is focused on schedule and budget. These competing targets often distract personnel from embracing newer technologies, bypassing lower-cost options and faster implementation.