CMC (Chemical Manufacturing Control) refers to chemistry, manufacturing and control, often referred to as pharmacological research, and includes the study of product structure and quality attributes, manufacturing process development, comparability studies, process identification (characterization) and validation of GMP commercial production consistency. The development of CMC manufacturing processes is important for the commercialization of gene therapy products, which determines whether the conditions and manufacturing processes of R&D pilot scale can be consistently and consistently reproduced in pilot, large scale and commercial scale production.
Genevoyager adopts the concept of "Quality by Design (QbD)" to guide the process of AAV drug development and production. We fully utilize our existing CMC process development capability, systematic analysis method development capability, and rich project experience to produce high quality and stable AAV products to save cost for our customers.
Vector design, optimization and screening platform：Including vector elements, large-scale screening platforms
Upstream process development：Including cell line development, media screening and optimization, transfection/infection system optimization, bioreactor optimization and scale-up
Downstream process development：Including harvesting and lysis process optimization, column chromatography process, gradient centrifugation process, clarification, concentration and buffer replacement
US: 3675 Market Street, Suite 200, Philadelphia, PA19104 Tel: +1 (215) 205-6963 | +086 027-65023363
E-mail: hui.wang@genevoyager.com
China: No128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China Tel: 17720522078
E-mail: marketing@genevoyager.com
US: 3675 Market Street, Suite 200, Philadelphia, PA19104 Tel: +1 (215) 205-6963 | +086 027-65023363
E-mail: hui.wang@genevoyager.com
China: No128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China Tel: 17720522078
E-mail: marketing@genevoyager.com
