Contributing Editors

  1. How Does A Mature QMS = Fewer Drug Supply Chain Disruptions? 8/16/2021

    The FDA’s Office of Quality Surveillance launched a voluntary program to evaluate manufacturers’ quality management systems to inform decisions on the future development of an FDA rating system characterized as quality management maturity. This article explains the importance of QMM and what that looks like to the FDA.

  2. SARS-CoV-2: Massey Univ. Profs Develop Method To Quickly Sequence Genome 8/13/2021

    It was a matter of time before the world saw variants emerge that increased the transmission rate of COVID-19. A research team led by two of these authors at Massey University have developed a new next-generation sequencing method for the ultrafast sequencing of the SARS-CoV-2 genome, which cuts the sequencing time by more than half.

  3. Update On Regulatory Strategies To Mitigate Mutagenic Impurities In Prescription Drugs 8/11/2021

    Addressing small molecule woes with nitrosamine and similar impurities is becoming patient critical. Recent questions and answers from the European Medicines Agency (EMA) provide clarity for the pharmaceutical industry. This article also delves into additional mutagenic impurities that are emerging.

  4. B. Cepacia: A Case Study For Determining Objectionableness In Drug Manufacturing 8/9/2021

    After introducing the subject of colonization and opportunistic pathogenicity in part 1 of this 2-part series, the authors return to discussing B. cepacia in more depth in this article.

  5. Objectionableness: How To Know If A Microorganism Poses A Risk In Your Drug Product 8/6/2021

    It is important to consider at the beginning of an exploration of species “objectionableness” in microbiological analysis that this idea is unique to our specific corner of the world. If you search for a definition of objectionable organisms in a microbiology reference text, you are unlikely to find one. This article, as part 1 in a 2-part series, meets that need.

  6. Beyond Vaccines: Envisioning A New Approach To Protecting The World From Infectious Disease 8/4/2021

    What if we could create a more efficient way to give the body a “rapid response team” of antibodies ready to take on invading viruses? Enter endogenous therapeutic antibody production, or ETAP.

  7. Expansion Options For Adherent Cell Therapy 8/4/2021

    While the stirred tank bioreactor is the workhorse of the biopharmaceutical industry, there are applications for which cells can’t be effectively cultured in suspension. Beyond the petri dish and the T-flask, many in our business have not had interactions with the numerous and sometimes niche solutions for adherent cell culture. This article discusses our options in this field.

     

  8. Why We Shouldn’t Be Categorizing Digital Therapeutics As Drugs 8/2/2021

    Payers and health plans handle digital therapeutics inconsistently. They sometimes treat them as medications. The manufacturer would have a role in this determination. This article delves into what digital therapeutics are and are not, and why the industry should not be categorizing them as drugs.

  9. Decoding The Immune Synapse To Create Novel Immunotherapies 8/2/2021

    The potential of T cell therapies to be curative by harnessing our own immune repertoire has exciting implications for cancer and many other immune-mediated disorders.

  10. EMA Publishes Guideline On Quality Documentation For Medicinal Products 8/2/2021

    This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.