Analytical method transfer is the documented process that qualifies a laboratory to use the method that originated in another laboratory, ensuring that the receiving unit has the procedural knowledge and ability to perform the procedure as intended. Analytical methods are commonly transferred from the originating (transferring) site to other laboratories during the clinical, scale-up, or commercialization phases of oral thin film product development. CD Formulation provides cGMP-based oral thin film analytical method transfer services and adheres to internationally recognized quality management standards to ensure the correctness and reliability of analytical methods.

Fig.1 Analytical method transfer. (George L. Reid, 2020)

Our Oral Thin Film Analytical Method Transfer Services

Changing oral thin film drug production sites and analytical testing sites are among the most common types of technology transfers, and analytical method transfers are a crucial part of site transfers. In the process of an analytical method transfer, communication between the laboratories is vital for a successful method transfer. CD Formulation has a professional team dedicated to analysis method transfer studies. We not only support the transfer of client's methods and techniques to external laboratories or our own for ongoing research but also assess whether the methods we have developed and validated can be easily transferred to your required laboratory. We ensure that any limitations are identified and addressed. Our analysis method transfer services include but are not limited to:

Method Assessment

Evaluation of the existing analytical method for oral thin films includes reviewing the method validation, specificity, sensitivity, accuracy, and precision.

Develop Transfer Protocol

Develop a comprehensive transfer protocol, including outlining key steps, acceptance criteria, timelines, responsibilities, and resources required for successful transfer.

Comparative Testing

Conduct comparative testing to confirm the equivalence of transfer methods.

Co-Validation of Laboratories

Conduct inter-laboratory validation to assess process repeatability.

Revalidation/Partial Revalidation

Re-validation/partial re-validation is performed to ensure the accuracy and completeness of the information when comparative testing is not available at the transfer laboratory.

Validation Protocol

Development of a validation protocol for the transferred analytical method, including the design of experiments, acceptance criteria, and documentation requirements.

Testing and Validation

Conduct the validation studies to demonstrate that the transferred analytical method performs as intended, ensuring its reliability and accuracy in the new laboratory.

The Workflow of Oral Thin Film Analytical Method Transfer

Before an oral thin film analytical method is transferred, the development and validation of the suitable analytical methods represent a critical component of the entire life cycle of oral thin film drug development, the implementation of the transfer process must be carefully planned and the transfer process is as follows:

Fig.2 The Workflow of Oral Thin Film Analytical Method Transfer. (CD Formulation)

How to Determine Acceptance Criteria for Oral Thin Film Analytical Method Transfers?

The extent of testing during oral thin film analytical method transfer should be commensurate with the method’s capability and its intended use. Based on the intended use of the method, we determine appropriate acceptance criteria, which include:

• Evaluation of inter-laboratory differences
• System suitability
• Precision
• Limit of Detection (LOD)
• Limit of Quantitation (LOQ)
• Reproducibility
• Selectivity
• Sensitivity
• Recovery
• Comparison to the appropriate specification or method requirements

Advantages of Our Oral Thin Film Analytical Method Transfer Services

• Our team consists of experienced scientists with a deep understanding of oral thin film analytical methods and extensive experience in method transfer and validation.
• We provide a comprehensive plan for method transfer, validation, and documentation, ensuring that all aspects of the transfer process are thoroughly addressed.
• Typical analytical characteristics are used, including accuracy, precision, specificity, LOD/LOQ, linearity, range, and robustness.

CD Formulation leverages our extensive experience in the oral thin film analytical method transfer process to help our clients achieve seamless and efficient method transfers and accelerate the time-to-market of oral thin film. If you require our oral thin film analytical method transfer services, please contact us by phone or email, and our colleagues will get back to you within three working days.