Support the characterization of process and product related impurities in process development and manufacturing production by using state-of-the-art physicochemical analysis and bioanalysis to improve the process. Cooperate with other departments to develop the new analytical methods to identify the characteristics of new products. Develop and transfer bioanalytical methods to CROs to support the pharmacokinetics and immunogenicity evaluations of preclinical and clinical studies.
Chemistry team possess the expertise on design of synthetic route and preparation of drug target from milligram to kilogram scales. Our capability includes synthesis of novel compounds, library synthesis, design of specific targets, and protein PEGylation/chemical modification.
Apply the established mammalian recombinant protein expression systems to establish cell line using CHO-K1, CHO-S, CHO-DG44, and DXB11. We have successfully completed projects for monoclonal antibody and non-Ab recombinant proteins. Our capability include stable cell line generation from vector construction to research cell bank (RCB) , large scale transient expression with different CHO cell lines and 293 cell lines, and 3L to 5L bioreactor expression with different CHO cell lines.
Formulation development for small molecules and biological drugs listed in pipelines. The developments of biological drugs include monoclonal antibodies and recombinant proteins. The dosage forms can be liquid or lyophilized forms in combination with relevant container closure systems such as vials/stoppers/caps, syringes/plunger stoppers/tip caps, or cartridges/stoppers/crimp caps. Our capability includes preliminary formulation development for preclinical studies, prototype formulations for early clinical trials, commercial formulation for late phase clinical and launch, and preliminary fill finish process identification and optimization.
We have successfully developed Ropeginterfron alpha 2b process for commercial production. Additionally, the capability of process development is continuously expanding. Currently, the process development capabilities include process development for microbial and mammalian cell protein production, protein purification, protein chemical modification, formulation, and injection filling for protein and protein-modified drug development.