What is Changing Analytical Method Transfer Today? Part 3: Methods Across Borders

By April 23, 2018


Part 3. Methods that transfer across borders

There’s a new analytical testing landscape taking shape, and it’s having a big effect on how we develop, transfer, and update methods. Data quality and business efficiency are both at stake. Are you ready?

Let’s find out. This series explores the drivers, challenges, and payoffs you face, whether your analytical method is bound for the lab down the hall, or the lab halfway around the world.

Global drivers in regulated industries

A scientist at a major global pharma company estimated that an analytical method could see up to 100 transfers in its lifetime. Increasingly, such transfers will take place across geographic borders.

One driver for increasing geographical transfer is the sheer potential emerging markets hold. In 2011, the IMS Institute for Healthcare Informatics identified seven countries expected to see 7.5% per year or better growth in the pharmaceuticals market; by 2015, the list had grown to 17 countries. The top 10 pharmaceutical companies in emerging markets received 29 to 33% of their total sales from those markets as of 2012. And, in a May 2017 survey, industry professionals rated these emerging markets as the top growth driver for pharma and biopharma.

 

What’s Changing Analytical Method Transfer Today? Part 3: Methods Across Borders

 

Pharmaceutical companies are targeting those countries to build patent portfolios, partnerships, and local operations. As of December 2012, the French pharmaceutical giant Sanofi had 40 manufacturing sites in emerging countries. At the same time, 30% (about 11,500) of Merck Serono’s employees worked in emerging-market countries.

The people who live in these countries don’t merely want access to better medicines; they also want to grow their own pharmaceutical industries. Of 15 emerging-market countries recently surveyed, six require local investment in R&D or production for market access, and all 15 present substantive market advantages for foreign companies that make local investment. Benefits include market access, shorter times to regulatory approval, tender or reimbursement preference, avoidance of import tariffs, and ease of export to trade partners.

For example, Russia set goals to substitute domestic alternatives for half of all generic drugs by 2017, and to manufacture half of all new drugs in-country by 2020. This has spurred investment in Russian pharmaceutical manufacturing and the development of Russia-based operations by major pharmaceutical companies.

Challenges in transit and transfer

As your technology, expertise, and commerce flow between these countries, your methods travel as well. That’s where challenges come up.

Compliance and data integrity are key concerns. While more than 140 countries use U.S. Pharmacopeia guidelines, not all regulators apply the same testing requirements such as those found in Chapter <621>. Different labs may therefore begin a transfer with different method requirements regarding acceptable data or how to interpret measurements.

Seemingly negligible details can still have a significant impact. In one case, a “direct” method transfer from a European to an American lab produced disparate results. After a lengthy (and likely, costly) analysis, investigators found a difference in test tubes between the two labs at the root of the problem. The method had specified size, but not brand. The brand used by the transferring lab, which had a different stopper type, was not available in North America.

Such subtle differences can apply to reagents and materials as well as lab equipment. In another case involving a straightforward HPLC method, the receiving lab passed the initial transfer but then failed in testing its first two batches of API. The very slight deviation came down to the different weighing techniques between the two labs.

Distance itself may pose a hurdle. Ideally, one or more scientists from the transferring lab will travel to the receiving lab to help validate the method onsite. Yet logistics, time, and budgets may not always make this possible.

Conditions on the ground matter

The local physical environment can also affect method performance. Differences in ambient heat and humidity in the originating and receiving lab locales can change performance. High humidity in particular can affect detector readings. High environmental temperatures can cause problems with instrument heaters. Ambient temperature in one region may hover around 22°C, while another country’s average may exceed 30°C. These differences can lead to significant deviations in analyte elution, and hence quantitation for applications such as amino acid analysis, which are known to be very sensitive to temperature variation.

Taking a global view

The increased globalization of analytical efforts requires highly robust methods, and renewed adherence to SOPs. Receiving labs must meet predetermined and clearly defined acceptance criteria for method success. And your careful attention to staff training – preferably in person – and clear procedures go a long way. The right methods, practices, and equipment will ensure your success in method transfer around the globe.

In closing…

Your ability to navigate the new method transfer landscape is only beginning. See how you can update and transfer methods seamlessly from HPLC to UHPLC, and ensure that you—and your methods—are ready for any challenge.

Visit waters.com/methodtransfer for ideas on how to approach change.

 

References

 

 

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