Guest Columns

1. What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I 8/8/2022

   One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.

2. Data: The Near Future Of Regulatory Info Management In Europe 7/29/2022

   Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.

3. CAPA System Best Practices For GMP Compliance 7/25/2022

   A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices. 

4. 3 Strategies For Optimal Oversight Of Your Outsourcing Partner 7/20/2022

   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.

5. Bioprocessing Sees Continued Improvements In Batch Failure Reductions In 2022 7/13/2022

   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.

6. FDA Seeks Comment On ICH Q9(R1) Quality Risk Management 7/5/2022

   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. 

7. Market Tumult And 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?

8. 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. 

9. FDA Updates Guidance For Investigating OOS Test Results 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.

10. 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.