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).

 

Drug Product Release - Analytical Testing Laboratory

 

Our current Good Manufacturing Practice (cGMP) laboratory in Wixom, Michigan specializes in FDA GMP drug product release and stability studies.

 

Velesco Pharma can also perform routine analysis, from simple melting point determination or UV/VIS scan to GMP stability testing. Please complete the substance submission form for Velesco’s analytical testing laboratory services.

 

Our case studies for analytical method development challenges provide a brief taste of the value our analytical services can bring to your product development process.

 

Stability-indicating analytical methods Drug substance Drug product (tablets, capsules, syrups, etc.) 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