Biosimilar Manufacturing solution center

1. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

   This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

2. The Stepwise Path Lilly Mapped From Paper To Digital Logbooks 4/30/2026

   Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

3. Selecting The Right eQMS To Maximize Quality Maturity 4/23/2026

   Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

4. Do Changes Signal The End Of Biosimilar Regulatory Redundancy? 4/23/2026

   First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.

5. FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing 4/22/2026

   The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

6. Life Cycle Assessment Of Extended Use Strategies For Single-Use Assemblies 4/17/2026

   Examine how extending the use of single‑use assemblies can significantly reduce emissions, resource consumption, and waste in bioprocessing, offering a data‑backed path toward sustainability.

7. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

   Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

8. FDA's New Flexible CMC Framework For CGT 4/14/2026

   The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

9. How To Implement Post-Approval Changes On A Global Level 4/14/2026

   To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

10. The Business Case For Continuous Manufacturing In Biologics 4/14/2026

    The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.