- Global pharmacopeias are evolving - is your lab ready?
- QC leaders must balance compliance, sustainability, and operational risk
- Flexibility is becoming a requirement, not a preference
- Learn how Partner in Change enables confident, lower-risk transitions
From evolving pharmacopeia to sustainable QC, at your pace
Endotoxin testing is entering a period of meaningful transition. Across global QC laboratories, long‑established LAL workflows and legacy instrumentation continue to support daily operations. At the same time, regulatory guidance and industry expectations are evolving, prompting many teams to reassess how they plan for the future of endotoxin testing.
Recent pharmacopeial updates reflect this shift. In the United States, USP <86>, official as of 2025, recognizes recombinant Factor C (rFC) as a compendial method. In Europe, Ph. Eur. 2.6.32, now integrated into 2.6.14, formally establishes rFC as an accepted method across EU member states, with further alignment in water testing monographs. The British Pharmacopoeia followed with Appendix XIV C in 2024. In Asia‑Pacific markets, including Japan, China, and South Korea, recombinant methods are referenced in guidance chapters, signaling momentum toward broader adoption.
Despite this progress, change in QC environments cannot be rushed. Method transitions, validation planning, and instrument lifecycle decisions require careful evaluation. Many laboratories are asking not whether change is coming, but how to approach it responsibly.
Partner in Change is Lonza’s response to this reality.
Rather than focusing on a single product or forcing immediate conversion, Partner in Change is designed to support laboratories at every stage of their journey. Teams can continue using validated LAL methods today while exploring rFC when timing, regulatory comfort, and internal readiness align. Modern instrumentation, such as the Nebula® Multimode Reader, provides a flexible platform that supports both current and future assay workflows, allowing labs to modernize infrastructure without committing to immediate method change.
Equally important is the ecosystem behind the transition. Sustainable QC evolution requires more than an assay. It depends on the integration of hardware, software, services, and scientific expertise. Through Partner in Change, Lonza brings these elements together, offering practical resources, regulatory context, and technical guidance to help laboratories make informed, confident decisions.
As pharmacopeial guidance continues to evolve worldwide, laboratories that plan proactively will be best positioned to adapt without disruption.
To explore transition pathways, downloadable toolkits, and expert resources tailored to your lab’s needs, visit the Partner in Change landing page and learn how Lonza can support your next steps.
