When looking for a company to provide analytical method development services, one should look for two key qualities:
- An AMD team experienced in a variety of method development and validation projects with a proven track record in developing and validating analytical procedures used for clinical and marketed products
- An AMD lab equipped with modern cGMP instrumentation, especially HPLC, UPLC and GC capabilities with multiple detectors and software designed to evaluate peak purity and identity
The ADM leadership team at Ferndale Contract Manufacturing has over 100 years of combined experience in analytical chemistry and method development.
- Tim Hurley: AMD Supervisor. 35 years of method development and Quality Control experience in the pharmaceutical industry. Author on over 25 publications ranging from preparative chromatographic isolations to the separation of antibiotics, steroids and pharmaceutical degradation products. Inventor on over 10 U.S Patents.
- Linda Napoletano: AMD Senior Analyst. 20 years experience in analytical method development, QC analyses on raw materials, finished products and products on stability. Expert on data storage and security.
- Melissa Klimaczak: AMD Analyst. 15 years experience in analytical method development, QC analyses on raw materials, finished products and products on stability.
- Alice Ginter: AMD Manager. 35 years experience in the pharmaceutical industry.
- Dr. Leon Dupuis: VP Quality Control and Validation. 35 years experience in pharmaceutical method development and validation activities.
In the past 5 to10 years, we have seen major advancements in: HPLC, UPLC chromatography and Software, especially with new instrumentation, detectors and HPLC/UPLC column chemistry. For example HILIC columns, new UPLC column bonded-phase (column) chemistry allowing for improved analyte separations; User friendly Mass spectral detectors, and RI detection with improved baseline stability;
But technology isn’t the only thing that has influenced the evolution in AMD. Regulatory agencies worldwide including the FDA, EP, JP, etc, have steered analytical method development and validation in profound ways. The regulatory agency requirements for testing various attributes of different products have steadfastly influenced the development of new methods, not only for the potency and purity of products, but also for the determination of essential physical properties of products.
If you’d like to learn more about AMD, or any of the other services Ferndale Contract Manufacturing provides, please call 877-548-0122 or fill out a contact form on our website.