Pace Analytical
1 services found

Pace Analytical services

Life Sciences - CMC Pharmaceutical Development - Gene Therapy

Gene Therapy Drug Development Services

Establishing a robust process for gene therapy drug production enables pre-clinical development and ultimately, formulation development for clinical trial materials. To support this process, specific strategies need to be developed for: Secondary structure assessment and sizing. Oligomeric state of nucleic acid particles in solution. Purity analysis and quantitative detection of primary components. Degradation products in raw materials. Process samples and final drug substances.