We offer cell line development service for protein drugs. 3-5 months to deliver a highly expressed and stable cell line.
We offer cell line development service for protein drugs. 3-5 months to deliver a highly expressed and stable cell line.
Media development and critical process parameters development for high expression and better product quality, tech transfer and scale-up. Serum-free media development in shake flask for screening of various basal and feed media. Lab scale process development in shake flask for optimization of 4-5 process parameters and feeding strategy. Three bioreactor runs to establish lab scale cell culture process. Titer of lab scale process: not less than 3g/L.
Clarification, affinity capture, virus inactivation, AEX chromatography, CEX chromatography, nano-filtration, UF/DF, etc. We optimize process parameters and select resin and membranes at this stage. Tests include protein concentration (UV testing), SEC-HPLC variant (SEC-HPLC), rCE-SDS size variant (rCE-SDS), nrCE-SDS size variant (nrCE-SDS), CEX-HPLC/cIEF charge variant (CEX-HPLC)/ cIEF, residue host cell protein (ELISA), residue protein A (ELISA), residue DNA (qPCR).
We Choose packaging material as Ch-P, EP, and USP required. Formulation process of drug substance will sustain adequate stability at 10-50mg/ml under various manufacturing conditions. Formulation study is designed to address potential stability problems at high concentration by selecting appropriate excipient and monitoring critical quality attributes in designed formulation matrix under accelerated storage conditions. A number of quality attributes will be evaluated: viscosity, particles, visual appearance, charge isoforms, aggregation and degradations. Formulation process of drug product will sustain adequate stability at 10-100mg/ml in FDA/EMA/NMPA registered containers under various manufacturing stresses.
Analytical method development, tech transfer, and qualification/validation: biological activity, protein content, purity, molecular weight, glycosylation modification, host DNA residues, host protein residues, isoelectric point, ultraviolet spectrum, peptide mapping, bacterial endotoxin, sterility, osmotic pressure molar concentration, abnormal toxicity.