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Routine pharma labs are under constant pressure to do more with less
From R&D to QC, every lab faces the same reality. Analytical demands keep increasing, the number of samples continues to rise, and regulatory expectations continually evolve.
As these demands multiply, many labs will reach a breaking point where legacy instruments and operators can no longer keep up due to:
- No room for headcount expansion
- Business sustainability mandates
- Rising solvent and waste costs
- Increasing regulatory scrutiny
- Aging HPLC instruments
And despite these compounding issues, many labs are still hesitant to modernize old methods because of two major concerns: revalidation and compliance.
Understanding revalidation and compliance
Modernizing routine methods does not automatically require full revalidation. The right approach depends on your goals, constraints, and regulatory strategy.
In practice, modernization can include:
- Adjustments under USP <621> to reduce solvent use and run times
- Method scaling to improve analytical throughput
- Full revalidation when appropriate
With a controlled, step-by-step approach, labs can define validation scope, document changes, and maintain compliance with confidence.
Our case study, conducted at the Opella site in Compiègne, France, demonstrates how a controlled HPLC-to-UHPLC method modernization approach can sustainably transform routine analytical workflows.
How Opella transformed routine HPLC workflows, reduced run times by over 90%, and unlocked measurable productivity and sustainability gains
At the Opella site in Compiègne, method modernization helped deliver measurable improvements in speed, cost, and sustainability. By taking a structured approach, the team consolidated two aging HPLC methods into a single UHPLC method. The impacts were immediate.
- Slashed method run-time from 60 minutes to 5.5 minutes, significantly reducing cost per analysis
- Saved 20 days of run time per year, improving cost efficiency, safety, and sustainability
- Used 2.5 L less solvent per sequence, cutting both solvent usage and disposal costs
This example illustrates how HPLC-to-UHPLC modernization, supported by full method revalidation and proper updates to manufacturing authorization documentation, can turn routine workflows into a lasting operational advantage.
“By dramatically reducing analytical time and minimizing solvent use, the Thermo Scientific Vanquish Flex UHPLC sets a new standard for efficiency, sustainability and safety in the lab.”
Xavier Lelièvre, Head of Quality at Opella Compiègne
How modernizing reduces risks and helps future-proof your lab
Waiting to modernize your methods until absolutely necessary might seem justifiable in the short term. But in the long-run, outdated workflows, instruments, and software can introduce performance and compliance risks, eventually forcing change. Here’s how.
Aging systems increase downtime risk, create bottlenecks, and drive rising operating costs. As platforms age, service and parts availability may also decline, adding further strain on your operations.
At some point, modernization becomes forced. Staying proactive helps reduce risk and positions your lab for long-term efficiency, scalability, and compliance.
How to approach HPLC-to-UHPLC method modernization
Start by identifying methods that create the greatest operational challenges. From there, two modernization paths are possible:
Path 1: Optimize within USP <621> — fast and low risk
- Allows defined adjustments to parameters such as column dimensions, flow rate, gradient conditions, or injection volume, if method performance equivalence is demonstrated
In practice, this type of optimization supports measurable gains in throughput and solvent reduction.
Path 2: Full method modernization — higher effort, greater impact
- Involves redesigning the method, upgrading instrumentation, and fully validating the approach
While more resource-intensive, the long-term benefits in productivity, robustness, sustainability, and operational confidence are well-suited for high-impact, high-volume methods.
A complete solution for compliant HPLC-to-UHPLC method modernization
Successful modernization requires a structured and thoughtful approach, and often includes an integrated solution across hardware, software, and workflows. Thermo Scientific has a complete portfolio of solutions that directly support method optimization, day-to-day laboratory efficiency and scalability.
Vanquish Flex UHPLC Systems
Thermo Scientific Vanquish Flex UHPLC Systems are compatible with third-party CDS software and support straightforward and compliant method transfers under USP <621>.
- Maintain continuity with existing workflows and data systems
- Enable consistent, reproducible results across runs
- Increase throughput without workflow disruption
- Support smooth, compliant method transfer
- Reduce variability and need for re-runs
“The Vanquish Flex UHPLC system is highly flexible, provides excellent injection repeatability, consistent results and therefore minimizing sample repetitions. Its intuitive design includes LED lights that clearly indicate the status of the equipment, making it user-friendly and efficient.”
Ana Laura Castillo (Chemical Analyst) and Andrés López (QC Coordinator) at Opella Ocoyoacac
Chromeleon CDS Enterprise
Thermo Scientific Chromeleon CDS Enterprise helps provide regulated labs with a complete solution to maintain data integrity and meet 21 CFR Part 11 electronic signature requirements with confidence throughout the data lifecycle.
- Meets 21 CFR Part 11 electronic signature requirements
- Built-in tools supporting data integrity and audit readiness
- eWorkflow procedures for consistent method execution
- Spreadsheet-based reporting with full traceability
- Intelligent run control to help reduce re-runs
“Without the ease of access to the script command lines in Chromeleon CDS, we would not have been able to seamlessly integrate external systems into our analysis sequences.”
Salomé Soulier (Analytical Engineer) and Grégoire Mathieu (Senior Scientist) at Sanofi Sisteron France
Start your HPLC-to-UHPLC method modernization plan
Modernizing routine HPLC methods is not a one-size-fits-all process. To help you get started, we’ve put together a “Method Modernization Plan” with recommended products and workflow solutions for your routine lab.
Plan options
| Vanquish Flex + Current CDS | Vanquish Flex + Chromeleon CDS Enterprise | Vanquish Flex Duo + Chromeleon CDS Enterprise | |
| UHPLC modernization |  |
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| Workflow automation | — | |
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| Dual channel throughput | — | — | |
FAQs
Not necessarily. Frameworks such as ICH Q14, ICH Q2 (R2), and updates to USP <621> allow certain method adjustments without full revalidation, provided changes are scientifically justified and properly documented.
USP <621> allows defined adjustments to parameters such as column dimensions, flow rate, gradient conditions, or injection volume, if method performance equivalence is demonstrated.
For high-impact method changes, significant performance improvements to reduce testing failures, or when required by regulatory or internal quality standards.
For Research Use Only. Not for use in diagnostic procedures.