Heterologous recombinant expression of non-originator NISTmAb.

ABSTRACT: The successful development and regulatory approval of originator and biosimilar therapeutic proteins requires a systems approach to upstream and downstream processing as well as product characterization and quality control. Innovation in process design and control, product characterization strategies, and data integration represent an ecosystem whose concerted advancement may reduce time-to-market and further improve comparability and biosimilarity programs. The biopharmaceutical community has made great strides to this end, yet there currently exists no pre-competitive monoclonal antibody (mAb) expression platform for open innovation. Here, we describe the development and initial expression of an intended copy of the NISTmAb using three non-originator murine cell lines. It was found that,

SUBMITTER: Kashi L 

PROVIDER: S-EPMC6152460 | biostudies-literature | 2018 Aug/Sep

REPOSITORIES: biostudies-literature