Overview

When developing a new drug, there is a good chance there won’t be a well-established method in place for analytically testing the physical and chemical properties of a potential API. Also, when existing compounds are used together in a new formulation, analytical method development might be necessary in order to test the drugs’ interactions with each other, the formulation excipients or biological fluids. Whether you need help with dissolution method development or for analytical testing using HPLC, LCMS or any number of immunoassays, there are many companies that provide analytical method development services. In addition to method development and validation services, many of these companies have qualified scientific staff to perform analytical tests once the methods have been developed and validated. CRO’s with experienced analytical staff specializing in analytical method development and validation for early to late stage pharmaceuticals and drug development processes. Also have experience with over the counter (OTC) and neutraceutical products. They develop drug substance and drug product analytical methods from scratch, improve and expand existing methods, and even troubleshoot and fix problematic analytical methods. Our analytical method validation will be appropriate for your drug development program and comply with ICH guidelines. Phase of drug development is very important for efficient analytical method development and analytical method validation. Our analytical approach means our methods are “fit for purpose”. Thus, methods for IND submission during phase I support are scientifically sound, but challenged in validation to a lesser extent than a phase III product methods. Analytical method development involves Stability-indicating analytical methods, Drug substance, Drug product (tablets, capsules, syrups, etc.), and Forced degradation studies Impurities, Chiral method development, Stability testing in support of first-in-human studies, Content uniformity method development, validation and testing, Dissolution method development, validation and testing, Blinded comparator agent testing, Analytical method troubleshooting, Analytical method optimization, Extractables, leachables, Reference GMP regulations and standards, Cleaning verification guidelines and method development, validation, Technology transfer methods etc. Analytical method transfers (AMTs) are typically performed as a precursor to a critical step in the drug-development timeline, such as bringing on a new manufacturing facility, release testing of clinical or commercial material, or initiating stability studies at a quality-control laboratory. AMTs document that a new internal or external testing laboratory is qualified on the previously validated analytical method in order to generate current Good Manufacturing Practices (cGMP)-compliant data. According to the U.S. Food and Drug Administration’s (FDA) Analytical Procedures and Methods Validation for Drugs and Biologics: Guidance for Industry, “analytical procedures should be described in sufficient detail to allow a competent analyst to reproduce the necessary conditions and obtain results within the proposed acceptance criteria.” 1 Although this statement implies that the process should be relatively straightforward, it does not mean AMTs are as simple as providing the analytical method to the new testing site and assuming it will be able to execute the method successfully. Differences in instrumentation, techniques, procedures and even interpretations of an analytical procedure can lead to preventable AMT failures.