Service Platform
Process Development
Developing manufacturing process at various stages to help achieve project milestones on time
The development of manufacturing process for cell and gene therapy products is challenging due to the complexity of end products. Comparing to small molecule drugs and therapeutic proteins, genetically modified cells and viral vectors are less characterized and understood. Therefore, the manufacturing process plays an important role in controlling product quality. The process variation and performance could have a significant impact on the clinical trial and commercialization of products. With rich experience in process development to support early and late-stage cell and gene therapy projects, the process development team of WuXi ATU is dedicated to provide customers with high-quality services including a preliminary evaluation to demonstrate the feasibility, full development for a robust GMP manufacturing process, risk assessment and mitigation, phase-appropriate control strategy, process characterization and QbD, and life-cycle management (LCM). We will help our customers control the overall cost with no compromise on product quality to meet regulatory requirements as well as clinical and commercial demands.
The China Process Development Department of WuXi ATU has three technical centers in Shanghai and Wuxi, covering nearly （4,000ｍ２） lab and office space, with another（4,000ｍ２） under construction.
As a part of global and fully integrated function, China PD team works closely with our colleagues in US and UK to advance our technologies in cell and gene therapy areas. Our team consists of experienced scientists and engineers in virology, chemical engineering, biotechnology, and molecular biology. With diversified scientific background, we are able to drive innovation efficiently and solve technical problems quickly. We stay current with industry trends and regulatory guidelines, which have been frequently incorporated into our work to support clinical and commercial process development and to ensure product safety and efficacy.
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Service content
upstream cell culture process development, downstream purification process development, and test methodology development
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Product type
plasmids, lentiviral vector (LVV), adeno-associated viral vectors (AAV), adenoviruses (AV), herpes simplex virus and other oncolytic viruses (OV), immune cells such as CAR-T etc
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Process platform
escherichia coli plasmid production platform, adherent and suspended cell production technology platforms for LVV, AAV, AV, and OV, various immune cell and somatic cell technology platforms for cell therapy
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Service Characteristics
The process development team with decades of experience in this professional field can provide you with a full range of process development services with the following characteristics:
Advanced phase-appropriate development concept;
Large BSL-2 level standard laboratory;
Scientific development approaches;
Comprehensive process development packages;
Measures to effectively reduce the overall development and manufacturing cost.
