GUEST COLUMNISTS

• 3 Strategies For Optimal Oversight Of Your Outsourcing Partner

  Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.

• Bioprocessing Sees Continued Improvements In Batch Failure Reductions In 2022

  Bioprocessing is generally doing better than ever in terms of minimizing batch failures. In BioPlan Associates’ 19th Annual Report and Survey on Biopharmaceutical Manufacturing Production and Capacity, we discovered the leading cause of batch failures and more insights.

• FDA Seeks Comment On ICH Q9(R1) Quality Risk Management

  ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. 

• Market Tumult And The Need For Creative Funding For Life Sciences

  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?

• Mold Investigations Using Biofluorescent Particle Counting Systems

  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. 

• FDA Updates Guidance For Investigating OOS Test Results

  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.

• Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem

  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.