Biopharma Process Characterization

During the upstream 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, different purification steps, utilized during down-stream processing, can also significantly influence the product profile. We provide a standardized and highly customized process characterization services under the following categories.

Cell-line Characterization

To confirm the structural and functional stability of the cell, the protein expression profile of the Master & the Working seed is characterized using proteomic-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 the chromatographic process in the product. This work typically involves the 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 fluorescence spectroscopy. Based on the host species in use, Host Cell Protein / DNA analysis is provided as customized services.