Why analytical method transfer still fails in modern pharma labs

In pharmaceutical organizations, developing and validating chromatographic methods is a routine, yet resource-intensive, task.

Once a method is optimized and performs reliably, it’s natural to expect it will remain effective long term. In reality, the landscape is far more dynamic. Instruments are upgraded, systems evolve, and methods often need to be shared - whether across internal labs, global sites, or with external partners such as CROs, CMOs, and CDMOs.

To maintain efficiency and consistency, these methods should transfer seamlessly between teams, platforms, and locations. Unfortunately, that’s rarely the case.

Today, method transfer remains a highly manual and fragmented process. Scientists still exchange critical method parameters through emails, PDFs, or even printed documents. Receiving labs then re-enter this information by hand into their own systems, which is a time-consuming step that introduces the risk of human error, misinterpretation, and mismatched terminology.

The challenge is further complicated by variability between chromatography systems and software. An HPLC method developed on one platform may need adjustments on another due to differences in purge volumes, injection cycles, dwell times, or even parameter definitions. Small variations like these can dramatically impact retention times, peak shapes, and resolution, undermining method robustness and reproducibility.

The result is lost time in troubleshooting, inconsistent results, project delays, and regulatory submissions that are more difficult to defend. Experts across the industry are now developing solutions to address these challenges directly.

2. Why the industry needs a new approach

For years, laboratories have accepted this inefficiency as the norm. However, this is now beginning to change.

As pharmaceutical development timelines shorten, analytical teams face mounting pressure to work faster, reduce manual tasks, and ensure stringent compliance with regulatory requirements.

The path forward is now clear:

• Methods need to be digitized rather than described in prose
• Parameters need to be standardized rather than subject to reinterpretation
• Systems must be capable of automatically normalizing and adjusting methods across platforms
• Data has to be secure, traceable, and audit-ready

This approach goes beyond improving convenience. It is about strengthening reliability, ensuring consistency, and ultimately enabling faster delivery of therapies to patients.

3. The pistoia alliance: Building a foundation for digital methods

Recognizing the widespread challenges of method transfer, the Pistoia Alliance - a collaboration that includes pharmaceutical companies (GSK, Merck Sharp & Dohme LLC), technology vendors (ZONTAL, Agilent), and service providers (Astrix) - launched the Methods Hub initiative in 2020.

The project’s objective was to move analytical methods from manual, text-based formats into fully digitized, machine-readable instructions. This shift makes method sharing more efficient, accelerates implementation, strengthens traceability, and greatly reduces the risk of human error.

The Methods Hub initiative addresses several critical industry needs:

• Developing a common, standardized data format for method transfer using the Allotrope Framework technology
• Enabling integration with any Chromatography Data System (CDS)
• Capturing metadata and version control for compliance and audit trails
• Strengthening collaboration between internal teams and external partners by employing FAIR principles

By standardizing how analytical methods are structured, stored, and exchanged, the initiative provides a foundation for a more interoperable and automated analytical ecosystem.

4. From theory to practice: The role of digital twins and secure repositories

Digital solutions are now making this vision a reality. Instruments such as the digital platform allow researchers to generate digital twins of analytical methods - machine-readable, structured representations that can be securely stored, searched, and reused.

The end-to-end process with the digital platform functions as follows:

• A novel HPLC method is developed in a laboratory.
• The method is uploaded to the platform and converted into a digital twin.
• Researchers within the organization or external partners can search for the method.
• Once selected, the method is automatically normalized, adapting parameters to align with the target instrument.
• The method is ready to run. No manual retyping or interpretation is necessary.
• This method removes manual conversions and complex troubleshooting, enhances reproducibility, and ensures analytical methods remain consistent regardless of where, when, or how they are used.

5. Advantages for pharma, CROs, CMOs, and CDMOs

Digitalizing analytical method transfer creates value across the pharmaceutical value chain.

For pharmaceutical companies, it accelerates method transfer in R&D, manufacturing, and quality control. By reducing variability in chromatography data, teams spend less time investigating discrepancies and more time on innovation and production. It also provides greater flexibility to collaborate across global sites and with external partners, without delays caused by incompatible systems or manual rework.

For CROs and CDMOs, digital method transfer streamlines the onboarding of client protocols. Structured digital methods can be implemented directly into existing platforms, eliminating the need to interpret inconsistent formats or manually reconfigure methods. This reduces the burden of validation and troubleshooting, while improving speed, reliability, and client satisfaction, strengthening long-term partnerships in the process.

For regulatory and quality assurance teams, digitized methods deliver built-in traceability and audit readiness. A clear, version-controlled record of method changes simplifies submissions and inspections, reduces the risk of compliance issues, and supports stronger quality management systems.

6. The future of analytical methodology is digital

Digitizing chromatographic methods represents more than a technical improvement - it marks a shift in how analytical science is developed, shared, and applied. By eliminating manual bottlenecks and enabling true interoperability between systems, it accelerates scientific progress and helps ensure patients gain access to safe, effective treatments more quickly.

For laboratories still relying on static documents, email exchanges, or handwritten notes, modernization is now both possible and practical. The technology is in place, standards are taking shape, and the benefits - in efficiency, reliability, and compliance - are too significant to overlook.

About SciY

SciY is a software brand that provides a broad spectrum of scientific software solutions across the entire life sciences spectrum. SciY is a concept developed by Bruker BioSpin which emerged from collaborative efforts with various brand-neutral software partners, including Mestrelab, Arxspan, Optimal Industrial Technologies, Optimal Industrial Automation, and ZONTAL.

Fueled by a shared progressive entrepreneurial vision and the necessity to recognize the benefits and added value of a unified market presence and a diversified brand portfolio, these partners united their individual ventures under one collective brand - SciY, housed within the newly established Integrated Data Solutions Division of the Bruker BioSpin Group.

SciY consolidates all current vendor agnostic software platform and solution brands, and will encompass future innovations born from this collaborative synergy. A key motivation for SciY is to forge new and innovative, modular software solution platforms, meticulously tailored to meet the specific needs of their target markets and applications.

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