BIO From The Editor and Guest Columns

  1. A Functional History Of Process Validation, Part 1 – A Weak Foundation 8/7/2020

    This article is the first of a two-part series that describes the origins of process validation to explain the underlying concepts necessary to control the advanced bioprocess manufacturing technologies required to make the next generations of biopharmaceutical therapies.

  2. Maintaining Lab Operations Amid Coronavirus Restrictions 8/7/2020

    Obsidian Therapeutics CEO Dr. Paul Wotton developed a novel solution to the workforce and resource disruption caused by COVID-19 social distancing restrictions. Here, he shares insight on the features of the application, which he's made available to other biotechs cost-free.

  3. 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.

  4. COVID-19 And The Next Chapter In Ansun’s Turnaround Story 8/4/2020

    How Dr. Nancy Chang turned an embattled company in financial freefall and on the heels of clinical failure into a leading clinical-stage biopharma—and why Ansun Biopharma is a contender in the treatment of COVID-19.

  5. 3 Healthcare Changes Biosimilar Companies Must Prepare For 8/4/2020

    There are several changes I have been observing in the broader healthcare space that biosimilar companies must be prepared to consider to promote greater uptake of biosimilars and, in turn, greater cost savings.

  6. Advocates For AI In The Laggard Life Sciences 8/3/2020

    A team at Xavier Health is taking an unbiased lead on the adoption of artificial intelligence in the life sciences. Here are some biopharma use cases, and a peek at the progress they'll report on at this month's Xavier AI Summit.

  7. Big Data: Accelerating EXUMA Biotech In The Race To Rapid CAR-T Therapy 8/3/2020

    In pre-clinical studies using a modified lentiviral vector—whereby T cell genes are modified using a lentivirus—EXUMA Biotech has demonstrated that autologous vein-to-vein CAR-T could be possible in just 6 hours time. In 2021, the company plans to prove the viability of its Rapid Point of Care (rPOC) platform in the clinic. 

  8. Breaking Down The Science / Finance Language Barrier 8/3/2020

    Athersys CFO Ivor Macleod draws light on a problem inherent to—but not often directly addressed by—new and emerging biotech organizations.

  9. Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering 7/30/2020

    Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.

  10. The Case For Optimism In The U.S. Biosimilar Market 7/28/2020

    In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years. In this op-ed, Amgen's Chad Pettit shares why the U.S. has cause to be optimistic about the competition emerging in the U.S.