Analytical Methods Development, Qualification & Validation

Analytical Development

Utilize our fully managed analytical methods development services and benefit from our extensive knowledge and expertise in delivering analytical methods suitable for in-process analysis and release testing of the product.

Our laboratories contain state-of-the-art equipment supporting analytical methods development. We have expert knowledge of recombinant proteins, including monoclonal antibodies, vaccines, fusion proteins, growth factors and enzymes.

Analytical methods development is based on the principles defined in ICH Q6B guidelines. We develop methods adapted to the biochemical and biophysical properties of the molecule and its critical quality attributes to establish identity, purity, physical characteristics, and potency.

We select the methodology for the intended purpose early in the development process, supporting in-process control (IPC), release and/or stability testing. Finally, the robustness of the chosen method is evaluated for inclusion in the final product release panel.

We conduct analytical methods development activities in-house, leveraging our experience and techniques efficiently using design of experiment (DoE) tools. We provide various platform methods for common molecule or host types, evaluating the capability to accommodate the sample and matrix before progression to methods qualification and validation.

Rely on our extensive expertise and experience in analytical methods development services to accelerate your projects seamlessly.

Qualification & Validation

Leverage our streamlined analytical methods qualification and validation services, and benefit from our extensive expertise in delivering comprehensive documentation for future product development and regulatory approval.

Our analytical methods qualification provides the first documented assessment of the method’s performance, adhering to relevant guidelines and its scientific objectives. Validation, in contrast, confirms the method’s suitability for its intended purpose by meeting predefined objectives established during development and qualification. While qualification may suffice in early product development stages, method validation becomes crucial as the product approaches registration.

We generate standard operating procedures (SOPs) with system suitability testing (SST) and assay acceptance criteria during our qualification activities, producing a detailed method qualification report that justifies our findings. The qualification data informs the criteria for the more stringent validation phase.

For validation, we apply predefined acceptance criteria for each method, ensuring compliance with relevant guidelines. We prepare a thorough validation protocol, document all data, and establish acceptance limits for parameters such as specificity, linearity, range, accuracy, precision, quantification, and detection limits, tailored to each assay. These activities are executed within 3P’s robust quality system, requiring formal protocols, reports, and SOP updates.

Rely on our expertise in analytical methods qualification and validation to seamlessly advance your projects, providing all necessary documentation and support for successful product development and regulatory approval.