Developing high-producing and robust processes
With team of experienced scientists and proprietary development platform, GenScript ProBio provides custom services for upstream process development, ranging from optimizing Cell growth Process Development Service, screening production media, defining feeding strategies, to studying clone stability, and further scale-up to pilot and commercial production. We also offer a thorough analysis of growth rate, subcultivation ratios, cell mass, and other parameters. Upon request, we can perform additional specific process optimization studies or employ our scaled-down models to predict cell performance.
GenScript ProBio offers services for purification process development. For downstream process, Preclinical CMC protein purification is typically conducted through affinity columns. We also offer other chromatographic methods including gel filtration, ion exchange, and hydrophobic interactions. The purification tags are removed via a specific protease if desired, and the protein is further purified by gel filtration.
√ 6 month from DNA to Tox√ 12 month from DNA to IND√ 0.5kg/200L, 1.2kg/500L GMP DS is guaranteed to deliver
Intensified CMC Highlights
Intensified CMC Significantly Brings Titer Improvement
80% projects titer increase between 80%-150%
Robust and efficient production processes are crucial to the success of IND-Enabling studies and to the preservation of product competitiveness. GenScript ProBio's ‘Time & Quality-Balanced’ process development strategy, including using cell pool samples for purification preliminary development and cell culture process optimization, 3L samples for purification process optimization and formulation development, and 10/50L samples for process scale-up and purification process lock greatly shortens the process development timeline.
GenScript ProBio has developed a mature antibody purification platform process that allows clients to quickly establish a production process with an overall recovery rate of around 70% and with acceptable product characteristics, process and product-related impurities. GenScript ProBio will customize the processes to meet the unique needs of each client. For example , in the case of biosimilars, GenScript ProBio has effective techniques and tools to change the distribution of product glycoforms and charge isomers. In the case of recombinant protein with low stability, GenScript ProBio has developed different DoE tool boxes to ensure the titer and yield.
Determine the Biological Potency of Broad Types of Targets
Cell-based assay Dev. Capability
Different kinds of targets
Platforms for characterization
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