Process characterization is an integral part of pharmaceutical manufacturing and a challenging area of research. Zencore’s process characterization team has broad process development expertise across multiple modalities. Whether the production process is developed by Zencore or transferred from customers, we provide high-quality services to clients.
Zencore Biologics' process characterization services include risk assessment (RA), scale-down modeling (SDM), experimental design and execution (DoE), identification of critical process parameters (CPPs), and definition of design space (DS). Comprehensive, in-depth studies are conducted to assess the rationale behind the operating ranges of production process parameters and the scientific basis for control strategies.International Standard: Zencore Biologics adopts a quality by design (QbD) approach to process characterization, process validation and continuous life cycle management, which is internationally accepted for pharmaceutical development (ICH Q8-11).
Rigor: Utilizing current statistical methods and rigorous design of experiments (DoE) procedures, Zencore Biologics experts analyze the interactions between inputs (i.e., process parameters) and outputs (i.e., process indicators) to identify and verify critical quality attributes.
Flexibility: Zencore Biologics scientists adapt to designing and evaluating necessary study requirements for both customer-developed processes and new processes developed at Zencore Biologics.
Rich experiences: Zencore Biologics has completed four process characterization studies for our clients, with three additional studies currently in progress.
Zencore team successfully completed the upstream process characterization of material production for a phase III clinical trial of a customer's the antibody, designated as a breakthrough therapy for accelerated approval in China. Our team designed the downstream process characterization scheme for the phase III clinical trial and assisted the customer in their completion of the purification process characterization. The BLA for the drug was approved by the NMPA. The client's antibody received the registration and listing approval certificate from the NMPA in December 2018. Our contribution to its development significantly accelerated regulatory approval and helped ensure the client's success in a highly competitive market.
