Proteins & Peptides Analytical Method Validation and Transfer

Analytical method validation and transfer are critical steps to ensure that the analytical procedures or methods developed can accurately and reliably analyze samples, consistently produce accurate results, and comply with current good manufacturing practices (cGMP). As one of the global leaders in protein and peptide formulation science and manufacturing, CD Formulation's protein characterization team provides reliable validation and transfer services for a variety of protein and peptide therapeutic products, such as monoclonal antibodies (mAbs), fusion proteins, bispecific antibodies, antibody-drug conjugates (ADCs), etc., following current USP/EP/ICH guidance, thereby reducing the cost, complexity, and overall timeline of drug development.

Purpose of Proteins & Peptides Analytical Method Validation and Transfer

Analytical method validation and transfer, a necessary test method, is a key step in selecting and optimizing methods for testing raw materials, intermediate materials, final containers, and excipients, ensuring that data complies with current good manufacturing practices (cGMP).

• Analytical method validation is an important part of the protein/peptide biopharmaceutical research process, aiming to determine whether the analytical method used is scientific and reasonable and whether it can effectively control the intrinsic quality of the drug. This test is a key component of quality control and plays an important role in the establishment of analytical methods. Only validated analytical methods can be used for quality control of protein/peptide biopharmaceuticals.
• Analytical method transfer, a process of documenting and experimental confirmation, aims to ensure consistent, reliable, and accurate test results between different laboratories.

Fig. 1 Analytical method transfer. (CD Formulation)

Our Proteins & Peptides Analytical Method Validation Services

Due to their special properties, biological products such as proteins and peptides require specific scientific expertise and regulatory knowledge. CD Formulation follows the current USP/EP/ICH guidance to provide a standardized analytical method validation process that complies with cGMP for your protein/peptide biopharmaceuticals and biosimilars to ensure that your biological products meet regulatory requirements and enter the clinical research stage smoothly.

We provide validation support for any analytical method that may be involved in the development and manufacturing of therapeutic protein and peptide biologics and biosimilars. For protein/peptide finished products, the following indicators are focused on.

• Pharmacopoeia routine tests, pH, moisture, osmotic pressure, etc.
• Validation of protein/peptide identity and purity analytical methods.
• Validation of process and product-related impurity analytical methods.
• Validation of in vitro release and permeation analytical methods.
• Validation of stability analytical methods.
• Validation of cell-based biological activity.
• Validation of animal model-based biological.

Our Validation Service Types Include:

• Full validation: This service is mainly for newly developed analytical methods.
• Partial validation: This service involves modifying an already validated method.
• Cross-validation: This service involves comparing validation parameters when using multiple methods.

Validation Content of Proteins & Peptides Analytical Method

According to ICH guidance, our validation content focuses include:

• Specificity
• Precision
• Accuracy
• Repeatability
• Reproducibility
• Linearity
• Range
• Limit of Detection (LOD)
• Limit of Quantification (LOQ)
• Stability
• Durability
• System Suitability
• Forced Degradation
• Method Revalidation

What Problems Can Our Validation Services Solve?

• Validate accuracy and precision to ensure that the measured values are consistent with the true values.
• Establish linearity and range to ensure reliable quantification of different analyte concentrations.
• Determine the LOD and limit of quantification LOQ to evaluate method sensitivity.
• Establish system suitability criteria to ensure that the analytical instrument is functioning properly.
• Test specificity and selectivity to accurately measure the analytes of interest.
• Evaluate robustness and durability to identify potential sources of variation in biological products.

Our Proteins & Peptides Analytical Method Transfer Services

The formal transfer of analytical methods is an essential cGMP process for all protein/peptide biologics development. CD Formulation follows the current USP/EP/ICH guidance to provide analytical method transfer services based on cGMP to ensure the correctness and reliability of analytical methods.

Our analytical method transfer services support the transfer of your methods or technologies to our analytical laboratories for ongoing research or the transfer of our developed and/or validated analytical methods to one or more laboratories designated by you, taking into account any restrictions, to ensure the smooth progress of your project.

Available Proteins & Peptides Analytical Method Transfer Services Include:

• Develop a comprehensive analytical method transfer protocol.
• Provide comparative testing for equivalence evaluation of the transferred method. Revalidation/partial revalidation will be performed when the transferring laboratory is unable to perform comparative testing.
• Optimize analytical methods as needed to ensure suitability and compliance.

Why Choose Us for Proteins & Peptides Analytical Method Validation and Transfer?

• We have extensive experience in performing any protein/peptide biologics analytical method validation transfer.
• We provide method validation at the appropriate stage in your protein/peptide biologics development and manufacturing process.
• All our workflows are completed in cGMP-compliant analytical laboratories.
• We provide flexible experimental options and customized solutions to meet the needs of different customers.
• All our method validations are performed using typical analytical characteristics, including accuracy, precision, specificity, LOD/LOQ, linearity, range, and robustness.
• We support method transfer for different needs.

Publication

Analytical method validation and transfer is one of the essential key factors for the successful development of protein/peptide biologics. CD Formulation is committed to providing integrated validation and transfer services to support the smooth implementation of your project. Please feel free to contact us if you are interested in our services or have further questions. We look forward to working with you to promote development and innovation in the biopharmaceutical field.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.