Ensuring Reliable API Crystallization Across Clinical Phases with Expertise”
Controlling and understanding your API’s crystal forms is critical not only in the early Phase of pre-clinical manufacturing but also including later phases of clinical trial manufacturing to commercialization. When new crystal forms appear of clinical trial manufacturing batches (CTM) the FDA will require prior to approval that the process can be controlled to only produce the desired polymorph. We provide the expertise to ensure each and every API manufacturing program will provide reliability and reproducibility in every CTM produced. Our partners have unsurpassed world-renowned leading scientific staff that will ensure your API program will be successful.
CEO at Drug Discovery Alliances
Deborah has decades of business development experience marketing contract services, drug licensing and new technologies to the pharmaceutical industry. She founded Drug Discovery Alliances, Inc. in 2001 to connect pharmaceutical and biotech companies with top industry contractors who facilitate and speed projects. Deborah earned a Ph.D. in Medicinal Chemistry from University of North Carolina, Chapel Hill and has worked as an organic chemist for Rhone Poulenc. She subsequently worked for Accelyrs and MDL, marketing molecular modeling technologies and databases including Beilstein and Crossfire to the pharmaceutical industry.
Latest posts by Deborah Minor (see all)
- Drug Discovery Alliances at CPHI Barcelona 2023! - October 6, 2023
- Enhancing Resilience in Pharmaceutical Supply Chains with Drug Discovery Alliances - September 4, 2023
- Igniting Innovation through Supplier Diversity: Collaborate with Drug Discovery Alliances at Chemoutsourcing 2023! - August 14, 2023