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):
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:
Our unique advantages can be included as follows:
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.