Contributing Editors

  1. Implementing Improved Analytical Methods To Support Vaccine Quality 12/18/2020

    Some of the new COVID-19-targeted vaccines are spurring the use of novel analytical technologies to support rapid and thorough characterization, which may help pave the way for other vaccine manufacturers to implement these technologies as well.

  2. CDMO Selection: Can We Eliminate The On-Site Audit? 12/15/2020

    On-site capability assessments are an indispensable part of the CDMO selection process. But, due to travel restrictions brought about by the ongoing pandemic, supply chain professionals, as well as development and clinical stage biotech companies that outsource, have no choice but to rethink and re-evaluate this step of the process. 

  3. Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: The M&A And Commercial Landscape 12/14/2020

    In this last part in a three-part series, we cover the M&A and commercial landscape implications, including historical and future deal trends, challenges in developing a successful commercial strategy, and what to watch out for as the NASH industry continues to reach new milestones.

  4. Bioprocessing Year In Review: 11 Key Trends Accelerated By COVID-19 12/11/2020

    Despite the morbidity, deaths, and terrible societal disruptions associated with the COVID-19 pandemic, 2020 will have created something of a positive outcome for the bioprocessing sector.

  5. FDA FY2020 Drug Inspection Observations And Trends 12/9/2020

    This article presents the FDA's most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years' worth of trends in drug GMP inspection enforcement.

  6. Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: The Second-Wave Candidates 12/7/2020

    In Part 1 of this three-part series, we discussed NASH, the market for treatments, the first wave of NASH drugs (at Phase 3) poised to change the management paradigm, and the currently ambiguous pricing/reimbursement landscape. Here in Part 2, we look to the most promising second wave of NASH drugs.

  7. Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products 12/4/2020

    A simple time to clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.

  8. Slow-Walking The Isolator: A Cautionary Tale 12/2/2020

    Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.

  9. Analysis Of The Non-alcoholic Steatohepatitis (NASH) Drug Pipeline & Market: Sizing Up The First Wave 11/30/2020

    NASH has remained a relative graveyard of drug development over the past 40 years: no disease-specific approved therapies have made it to market. This article analyzes the first wave of drugs (at Phase 3) poised to change the NASH management paradigm and shape the ambiguous pricing and reimbursement landscape.

  10. Managing CMO Quality And cGMP Compliance Capabilities: A Framework 11/25/2020

    When it comes to current good manufacturing practice (cGMP) compliance, many sponsors lose sight of their responsibility to ensure that each gram or dose of externally derived output fully meets its registered parameters and has been demonstrated by the contract manufacturing organization as manufactured in full compliance with the requirements of cGMP.