SCIENTIFIC DEVELOPMENT PQC’s scientific experts have decades of experience in the scientific development of human therapeutics, including small molecules and biologicals.  These scientists have established themselves as experts and thought leaders in their fields, through their work for various companies, clients and academic institutions, and through presentations at national and international conferences.  PQC has worked with numerous scientific and technical teams throughout the pharmaceutical and biopharmaceutical industries, and has an extensive network of contract facilities staffed with renowned experts in their scientific fields.  Specific functions in which PQC’s experts have been involved include the following: Small molecules Biologicals Process development Starting materials selection and justification Cell line development (vector design, host and clone selection) Active pharmaceutical ingredient (API) synthetic processes Upstream processing (cell culture, fermentation) Drug product process development Downstream processing (purification, intermediate and drug substance storage) Validation of process clearance (including viral validation) Drug product process development (liquid, frozen, and lyophilized; containers and devices) Formulation development Drug product formulation Product tolerance ranges (pH, buffers, salts, surfactants, temperature, etc.) Compounding, tableting, and capsulation Product formulation (API/drug substance and drug product) Packaging Device and delivery system compatibility Device and delivery system compatibility Shipping stability Analytical development Product characterization (chemical, biochemical, immunochemical, and biophysical) Analytical method development (in-process, lot release, and stability testing) Manufacturing and Testing (preclinical [GLP] and CGMP) Technical review/audit of manufacturing and testing facilities Process transfer Process characterization Process validation Reference standard production, testing, and management Analytical method transfer, qualification and validation Quality Control (QC) testing Stability program design and implementation (process intermediates, API/drug substance, drug product) Analytical support of investigations (nonconformances, out-of-specification and out-of-trend [OOS/OOT] results) Comparability protocol design and execution (process and analytical method changes)