During up-stream process, minor changes in cell-line, media-components and culture conditions of the cells can change the product profile and hence the therapeutic potential of the product. Similarly, purifications steps utilized during down-stream processing can also significantly influence the product profile. We provide standardized and highly customized process characterization services under following categories.
To confirm the structural and functional stability of the cell, protein expression profile of the Master & the Working seed is characterized using proteomics-based approaches.
Purification Linked Characterization
Chromatographic steps utilized in protein purification may bring impurities to the product of interest. In customized services, we analyze the probable impurities from chromatographic process in the product. This work typically involves understanding of the purification conditions and then developing and validating newer methods for analysis of impurities.
Host Cell Protein/DNA Impurities
Utilizing standardized protocols, host cell proteins at different stages of purifications are monitored through SDS-PAGE and LC-MS/MS based workflows. Host cell DNAs are amplified through PCR based methods and then detected using UV absorption spectroscopy. Based on the host species in use, Host Cell Protein / DNA analysis is provided as customized services.