Featured Bioprocessing Editorial

1. Solving Bioassay Challenges for Cell & Gene Therapies 7/1/2022

   Recently, USP held a bioassay training workshop that included regulatory considerations, analytical validation, and case studies related to bioassays for cell and gene therapy products that are also used for potency. This article recaps the key insights from the workshop.

2. Financial Market Tumult Shows The Need For Creative Funding For Life Sciences 6/29/2022

   Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?

3. Your How-To Guide For Mold Investigations Using Biofluorescent Particle Counting Systems 6/27/2022

   In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime. There's a better way to rapidly identify potential contamination and even confirm remediation in real time.

4. FDA Updates Guidance For Investigating OOS Test Results for Pharma Production 6/24/2022

   FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.

5. Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem 6/22/2022

   I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.

6. FDA Proposes Benefit-Risk Considerations For Product Quality Assessments 6/20/2022

   The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.

7. How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery 6/17/2022

   With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.

8. 2022 Outsourcing Trends In Biopharmaceutical Manufacturing 6/15/2022

   The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

9. FDA Publishes Guidance For Biopharma Container And Carton Label Design 6/13/2022

   The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

10. How To Test Master Cell Banks As A Starting Material For Gene Therapies 6/10/2022

    BioPhorum’s Cell and Gene Therapy Raw Materials team suggests a platform approach for testing a critical starting material for gene therapies – master cell banks (MCBs). This can ultimately influence and/or aid regulatory agencies when developing guidance or policies around gene therapy development and manufacturing.