BIO From The Editor and Guest Columns

1. Next Steps For AI, Machine Learning In Biopharma 11/25/2020

   A common thread is emerging among new biopharma companies; they’re hiring as many data scientists as wet lab scientists and their data server budgets are growing faster than that of their protein purification process. Here’s what that means to you and your company.

2. A Framework For Managing The Quality And cGMP Compliance Capability Of Your CMOs 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.

3. Inside Wugen’s Off-The-Shelf CAR T Mission 11/23/2020

   Founding CEO John McKearn, Ph.D. is all-in on the pursuit of lower-cost, off-the-shelf, allogeneic CAR T-cell therapies to address a host of oncological indications. Here, he shares the company's origin story, why the clock is ticking for Wugen, and what's next for the preclinical startup.

4. Advancing The State Of Aseptic Processing: Let’s Get Serious 11/23/2020

   It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.

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

   All partners in the vaccine supply chain recognize that the supply chain challenges posed by COVID-19 must be assessed and mitigated. Increased monitoring and corrective and preventive actions of supply chain issues and technical support for analytical challenges need to be addressed.

6. What’s Process Intensification In Practice? 11/18/2020

   I understand why “process intensification” is a buzzword embraced by the vendor and consulting communities. Now I want to know what the term means to biopharma companies, and whether—and how—you’re implementing it.

7. System Impact Assessment: A Risk Management Framework For A COVID World 11/18/2020

   Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most — that equipment performs as expected.

8. Moving Beyond Human Error In Biopharma Investigations And CAPA Programs 11/16/2020

   Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.

9. Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty 11/13/2020

   Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.

10. 8 Biotech Startup Lessons From Heat Bio’s Jeff Wolf 11/13/2020

    With apologies to Tom Petty, as biotechs go it’s the starting that’s the hardest part. No one knows this more than Jeff Wolf, who’s responsible for more than a few biotech startups. We caught up with Wolf for a candid talk on the toughest aspects of birthing a biopharma.