Process characterization is an integral part of pharmaceutical manufacturing and a challenging research work. Zencore process characterization team has broad process development expertise in multiple modalities, whether the production process is developed by Zencore or is transferred from customers, we can provide high-quality services to clients.
Zencore Biologics process characterization services cover risk assessment (RA), scale-down model (SDM), experimental design and execution (DoE), identification of critical process parameter (CPP), and definition of design space (DS). A comprehensive and in-depth study will be conducted to evaluate the rationale for the operating range of production process parameters and the science for the 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: Current statistical methods and using a rigorous design of experiments (DoE) procedures, Zencore Biologics experts analyze the interaction between inputs (such as process parameters) and outputs (such as process indicators) to identify and verify critical quality attributes.
Flexibility: Zencore Biologics scientists are flexible in designing and evaluating necessary study requirements for a process that is developed by customers or for a new process developed at Zencore Biologics.
Rich experiences: Zencore Biologics has so far completed 4 processes characterization studies for our clients and 3 processes characterization studies are ongoing.
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 granted by NMPA in December 2018 and our contribution to the development of this drug, greatly accelerated the approval by the regulatory agency and ensured the success of our client among the fierce competition.
