Pharmaceutical companies need to perform analytical method transfer when they expand to new locations, upgrade equipment, or bring in new staff. But moving methods between labs can be tricky. This is where comparative testing becomes essential.
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What is Analytical Method Transfer?
Analytical method transfer is the process that qualifies a receiving lab to use a method that originated in another lab. The receiving lab in question may be an internal or external lab. The same process is often called assay transfer or, for biological assays, bioassay transfer. Pharmaceutical companies require analytical method transfer for several reasons:
Expanding to New Locations: When a company opens new labs or facilities, they need to make sure the same testing methods are used across all locations.
Equipment Upgrades: If a company buys new or different equipment, it must ensure that its methods can still be used with the new technology.
Changes in Staff: New staff need to be trained in the methods used so they can perform tests accurately.
Method transfer can be complex. Here are some key steps to ensure a successful transfer:
- Early Submission of Documents: The sending lab should share the method and validation reports early in the process. This gives the receiving lab enough time to review and plan the transfer properly.
- Feasibility Testing: Build in time for feasibility testing, where the receiving lab practises the method to get familiar with it before starting the formal transfer.
- Clear Communication: Open communication between both labs is essential. Both teams should work together to create a risk-based approach to the transfer. This helps identify any issues early and ensures a smooth transition.
Each time a method is moved to a new lab, it must be tested to make sure it works properly in the new environment. This is where comparative testing becomes useful.
Types of Analytical Method Transfer
Comparative testing is one of four recognised approaches to analytical method transfer:
- Comparative Testing: Both labs analyse the same samples, and the results are compared against pre-agreed acceptance criteria.
- Co-validation: The receiving lab takes part in validating the method, typically by generating reproducibility data alongside the sending lab.
- Revalidation: The receiving lab carries out a full or partial validation of the method.
- Transfer Waiver: In justified cases, such as when the receiving lab already uses the method or a very similar one, a formal transfer may be waived. The reasons for the waiver must be documented.
Comparative testing is the most common approach, particularly for late-stage methods and more complex methods.
It is also worth separating method transfer from method validation. Validation shows that a method is fit for its intended purpose. Transfer confirms that an already validated method performs equivalently in a new lab.
What is Comparative Testing?
Comparative testing is the process of testing the same sample in both the sending lab and the receiving lab. The goal is to see if both labs get the same results. If the same results are seen, it confirms that the method works well in both locations.
At Southern Scientific, we use a 3-step process for accurate comparative testing:
Parallel Testing – The same sample is tested by both labs using the same equipment and procedures.
Following the Protocol – The testing is done according to a set protocol with clear instructions and acceptance criteria.
Results Comparison – The results from both labs are compared to make sure they are consistent.
By following this process, we ensure that the analytical method transfer is performed without damaging product quality.
Why is Comparative Testing Important?
Comparative testing is a key step in analytical method transfer for several reasons:
Ensuring Consistency: When a method is moved to a new lab, the results should remain the same as those from the original lab. Comparative testing helps confirm this consistency.
Meeting Regulations: Pharmaceutical companies must follow strict regulations when developing and testing drugs. Key guidance includes USP <1224>, the WHO guidelines on technology transfer in pharmaceutical manufacturing (TRS 1044, Annex 4) and EU GMP, under which the MHRA treats analytical method transfer as a requirement for contract manufacturing and testing. Comparative testing ensures that the transferred method meets these rules.
Maintaining Product Quality: Consistent and accurate testing methods help maintain the quality of drug products. Comparative testing ensures that changes in lab location, equipment, or staff won’t affect the results.
Why Outsource Comparative Testing?
Pharmaceutical companies often choose to outsource their method transfers. There are 4 key benefits to doing this:
Expertise: Labs that specialise in comparative testing, like Southern Scientific, have the experience and knowledge to handle these complex processes. State-of-the-art equipment and skilled staff ensures high-quality testing.
Unbiased Results: Outsourcing testing to a third-party lab adds an extra level of objectivity. Since these labs aren’t involved in developing the method, their testing is independent and unbiased.
Cost Savings: Setting up a specialised testing lab in-house can be expensive. Outsourcing to other labs can be a more cost-effective solution, especially for smaller pharmaceutical companies.
Convenience: Pharmaceutical companies can focus on their main work while another lab handles the testing. This makes the method transfer more efficient and hassle-free for.
Southern Scientific’s Comparative Testing
Southern Scientific is a leading testing laboratory with over 30 years of experience. We have a track record of working with some of the biggest pharmaceutical companies worldwide. Our comparative testing ensures your analytical methods are transferred easily. Here’s why you should choose us:
Experience: With decades of experience, our team has the knowledge and skills to ensure successful method transfers.
Accreditation: Our laboratory holds INAB accreditation to ISO 17025 (registration 194T), giving you confidence in the quality and traceability of every result.
State-of-the-art labs: Our labs are equipped with the latest technology. This technology allows us to deliver high-quality testing and accurate results.
Pharmaceutical and Biotechnology partnerships: We have extensive experience working with major pharmaceutical companies. You can trust us to handle your analytical method transfer needs with expertise.
Supporting Your Analytical Method Transfer
Transferring analytical methods is an important process for pharmaceutical companies. It ensures that testing methods are accurate and reliable, even when they are moved to different labs, locations, or equipment. Comparing test results is a key part of this process. Comparative testing ensures methods work the same in receiving labs.
Southern Scientific specialises in comparative testing for method transfer. As an INAB-accredited, ISO 17025 laboratory with over 30 years of experience, we can help ensure consistent and accurate results for your pharmaceutical company. By working with us, you can trust that your transfer will be handled carefully. Explore our full range of pharma and healthcare testing services.
