Analytical Method Development
Analytical Method Development and Analytical Method Validation
Velesco is a contract drug manufacturing organization (CDMO) with experienced analytical staff specializing in analytical method development and validation for early to late stage pharmaceuticals and drug development processes. We also have experience with over the counter (OTC) and neutraceutical products.
Velesco Pharma can become involved in your analytical Chemistry, Manufacturing, and Controls (CMC) program at any stage. We 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.
Our expert analytical chemists ensure that you will receive a robust, transferable, stability-indicating HPLC method that is tailored to your phase of development. Learn more about the importance of stability-indicating method and why it’s needed. 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.
An early phase clinical research 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. Velesco’s analytical scientists know how to run forced degradation studies and are familiar with the challenge of extracting and separating the new components, while minimizing changes to the method.
Velesco Pharma takes a practical approach to analytical method development, using solvents and columns that are affordable and readily available (unless a specialty item is necessary for the project).
