International Conference on Biomedical and Cancer Research
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Accepted Abstracts

Cell Culture Platform: A Potential Solution of Biologics Commercialization for Emerging Markets

Fai Poon*
Quacell Biotech Ltd, USA

Citation: Poon F (2019) Cell Culture Platform: A Potential Solution of Biologics Commercialization for Emerging Markets. SciTech Biomed-Cancer Sciences 2019. Tokyo: Japan

Received: May 28, 2019         Accepted: June 21, 2019         Published: June 21, 2019

Abstract

Biologic therapies are set to play a significant role in the treatment of a wide number of areas in various therapeutic domains, even though more traditional oncological therapies will continue to dominate the majority of medical treatments.  Complex biologic treatments require longer development periods and higher production costs when compared to that of small molecule generics. However, with the continued development of biologic agents, the economy of scale will increase and costs will be reduced for each additional unit of sale. Therefore, the ability to produce biosimilar at the lowest possible cost via cell culture has become the key to successful biosimilar development.  The increasingly competitive biosimilar marketplace requires biosimilar players to focus on rapid, low-cost cell line development with predictable product quality attributes with CHO-K1, CHO-S, Or CHO-SV etc cell line for large scale production of monoclonal antibodies. Traditional stable cell line development involves applying selection pressure (such as GS, DHFR system) to enhance and isolate clones with high expression of the protein of the gene of interest (GOI). However, the GOI is usually randomly integrated into the host cell’s genome, hence it creates heterogeneity and expression instability. Factors that contribute to instability include gene copy number, position effect, insertional mutagenesis, post-transcriptional and post-translational modifications. These clonal instabilities can be solved by a combination of host cell clone selection and vector design to generate a stable cell line that is suitable for production Hence, we present our platform CHO-K1Q cell culture technology that can increase titer while maintaining quality consistency to the IgG1  originator