4180 Mendenhall Oaks Parkway
PharmaCore® is a contract research organization with expertise in custom organic synthesis, cGMP scale-up, chemical process research and development, GMP analytical services, and medicinal chemistry services. For projects requiring long-term research and support, PharmaCore offers full time equivalent (FTE) contracts to maximize resources.
PharmaCore began in 2000 with a few scientists and a core catalog of molecular building blocks. Customers came to rely on the quality of PharmaCore compounds and began to request custom services. Ten years later, PharmaCore now employs over 40 experienced scientists at the High Point, NC headquarters and offers a variety of chemistry services to customers worldwide.
CUSTOM ORGANIC SYNTHESIS
PharmaCore scientists use diverse chemistries to produce active pharmaceutical ingredients and scaffolds. Chemists have extensive experience in amino acid synthesis, organometallic chemistry and cross coupling reactions, including Suzuki, Negishi, Sonogashira and Heck reactions. The 21,000 square foot laboratory is fully equipped with 33 bench-top hoods and 12 walk-in hoods. PharmaCore has the capacity to produce quantities ranging from milligrams up to hundreds of kilograms. Projects are sourced and quoted on either a time and materials basis or an FTE basis.
cGMP SCALE-UP AND PROCESS RESEARCH & DEVELOPMENT
PharmaCore’s experience in GMP scale-up dates back to 2001. In 2009, PharmaCore expanded its lab footprint to include a new 16,000 square foot pilot plant, bringing overall square footage to 36,000. PharmaCore now has eight GMP process suites where the specially trained GMP manufacturing team operates under the USFDA Guidelines for Bulk Pharmaceutical. PharmaCore manufactures APIs to support Phase I and Phase II clinical trials as well as pre-IND stage and tox stage. Recently, PharmaCore has supported APIs entering into Phase III. Production and analytical documents support process validation, stability studies, methods validation/transfer and reference standards.
PharmaCore expanded analytical services in 2009 when the new pilot plant began operation. Analytical services include: methods development, validation and transfer; ICH stability studies and testing; reference standard qualification; and raw material testing.
Additional information about PharmaCore services can be found at www.pharmacore.com.