Method Transfer

Analytical method transfer represents a critical step in the total process of drug-development and is generally used as a precursor to the development timeline. Method transfer plays an essential role in generating current Good Manufacturing Practices (cGMP)-compliant data by documenting whether the new internal or external testing laboratory is qualified on the previously validated analytical method. As a required GMP testing method, method transfer is utilized to ensure and prove that the method is performed as expected in the receiving laboratory environment.

Figure 1. Types of analytical method transfers

Below is a list of our available method transfer services (include but not limited to the following):

• Comparative Testing: The most common approach used for sample analysis and requires the testing of homogeneous lots of material by the sending and receiving laboratories.
• Co-validation of Laboratories: In this case, the transferring laboratory works with the receiving laboratory who is part of the validation team and performs the intermediate precision experiments to obtain data for the assessment of reproducibility.
• Revalidation/Partial Revalidation: Such approach represents the best option when the transferring laboratory is unavailable for comparative testing.

Our extensive experience allows our experts to work closely with our clients to determine the feasibility assessment of the methods, execution of the protocol and generation of the final report. We are dedicated to:

• Designing an efficient method transfer protocol
• Defining transfer tests and acceptance criteria
• Training of any relevant receiving personnel
• Execution of method validation tests and analysis in regulatory compliant laboratories
• Preparation of all method transfer documentation

Our unique advantages can be included as follows:

• Extensive experience in executing method transfers for various types of samples such as API, finish products and reference standards
• Generate compliant protocols that can meet the ICH guidelines and the USP
• Various types of equipment/procedures for both pharmaceutical and biopharmaceutical products available in our laboratory
• Efficient work flow allows us to provide quick turnaround time for our clients
• A flexible process is provided at our laboratory for more complex and/or technique-based methods

BOC Sciences has extensive expertise in analytical method development, validation and transfer for product development as well as commercial product release and stability testing. Our experts have many years of experience in supporting sponsors with full characterization of their drug substances, developmental formulations and commercial drug products. BOC Sciences offers unique advantages in method transfer service by maintaining a large breadth of testing capabilities and capacities through the latest top-notch techniques.

Reference:

1. Yanagihara, N., & Horiguchi, M. (2001). U.S. Patent No. 6,211,800. Washington, DC: U.S. Patent and Trademark Office.