Analytical Method Development and Validation

Analytical Method Development

CuriRx is perfectly positioned to help meet the growing needs of pharmaceutical, biotechnology, biosimilar, chemical and nutraceutical customers.

Analytical method development and validation play important roles in the discovery, development, and manufacture of a therapeutic product. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.

CuriRx is your source for professional analytical development services. At CuriRx, we believe that a well-developed method should be easy to validate. A method should be developed with the goal to rapidly test pre-clinical samples, formulation prototypes, and commercial samples. As the method development and validation processes advance, the information gathered is captured in the design and subsequent improvement of the method. Ideally, the validation protocol should be written only following a thorough understanding of the method’s capabilities and intended use. The validation protocol will list the acceptance criteria that the method can meet.

At CuriRx, we provide customized method validation services per applicable ICH/ICH/EPA/other regulatory agency guidelines. Some methods require only partial validation, while others require full validation. This usually depends on the developmental phase of product. The objective of an analytical procedure validation is to demonstrate that it is suitable for its intended purpose. Our expert analytical chemists ensure that you will receive a robust, transferable, stability-indicating HPLC method that is tailored to your product development needs. CuriRx can become involved in your analytical CMC program at any stage. We develop drug substance and drug product methods from scratch, improve and expand existing methods, and even troubleshoot and fix problematic analytical methods. Our method validation will be appropriate for your situation and comply with ICH guidelines.

Non-validated screening methods are used to monitor the synthesis of active ingredients or to confirm their identity during discovery and pre-clinical research. An early stage project usually does not have extensive analytical data. There are usually small, unknown impurities and unknown degradation profiles. During early development, large batch to batch changes in these impurity profiles can occur.

Our analytical scientists are familiar with the challenge of extracting and separating the new components while minimizing changes to the method.

Analytical methods are progressively optimized and a preliminary validation package is furnished as part of the IND application before Phase I safety trials are initiated. Methods for IND submission/phase I support are scientifically sound, but challenged in validation to a lesser extent than a phase III product method. All analytical methods should be fully optimized and validation completed before the NDA is submitted at the end of Phase III studies.

Method validation is a continuous process. The goal is to ensure confidence in the analytical data throughout product development.