COVID-19

  1. Partly Cloudy And Chance Of COVID: Bringing The Umbrellas And Raincoats For Cell And Gene Therapy 11/30/2020

    The tragic combination of infectiousness and lethality of SARS-CoV-2 and COVID-19 has been the greatest public health emergency of the past 100 years. But there is a way forward through science, discovery, translation, and execution.

  2. Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics 11/20/2020

    Supply chain challenges posed by COVID-19 must be assessed and mitigated. Increased monitoring and CAPAs of supply chain issues and technical support for analytical challenges need to be addressed.

  3. You Don't Know Phlow: The Backstory Of A Misread Biopharma Start-Up 11/9/2020

    No biopharma start-up has been as misconstrued, hastily judged in strategy and capability, or even labeled “political.” Now Phlow Corporation’s CEO Eric Edwards sets the record straight in an exclusive interview.

  4. COVID-19 Vaccine Manufacturing Challenges Spark Surge In Outsourcing Deals 10/19/2020

    As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.

  5. FDA Releases Guidance On Normal GMP Operations During COVID-19 9/18/2020

    Most FDA guidance on COVID has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologic manufacturers, whether or not they produce COVID-related products.

  6. 2 Years For Vaccine Tech Transfers? COVID-19 Won't Wait 9/2/2020

    A McKinsey & Company report, “Why tech transfer may be critical to beating COVID-19,” indicates the typical time to tech transfer a new vaccine is 27-29 months. Over 2 years for a tech transfer? Experts say yes. But not for COVID-19.

  7. 2 CDMOs Better Than All-In-One: The “Best-In-Breed” Trend 8/31/2020

    We’ve uncovered a global trend in drug development and manufacturing outsourcing. I spoke to senior executives at four service providers to learn the trend is part antidote – and potentially a better option – to the “one-stop-shop” composite.

  8. 4 Best Practices That Kept A Biotech's Clinical Trial Moving In The COVID-19 Era 8/12/2020

    The timely enrollment and progression of clinical trials is critical for a pre-commercial biotech company, as delays can keep treatments from getting to patients and cost an organization significant money and reputation. When you throw in a worldwide pandemic, it’s a whole new ball game.

  9. COVID-19's Impact On Bioprocessing: Insights From Industry Leaders 8/5/2020

    We interviewed 26 biopharma senior executives regarding how they are handling the crisis and its long-term impact on their operations. We found the pandemic has begun to catalyze and accelerate a number of significant changes, including many preexisting trends.

  10. Do The Math: No Shortage Of Vials For COVID-19 Vaccines 7/22/2020

    Fabian Stocker of SCHOTT has a soothing mathematical calculation to reduce our COVID-19 "vial shortage anxieties.” It also informs every drug developer to continue full speed ahead: There are vials for you as well.