Abstract
The protein productions strategies are crucial towards the development of application based research and elucidating the novel purification strategies for industrial production. Currently, there are few innovative avenues are studies for cloning, upstream, and purification through efficient bioprocess development. Such strategies are beneficial for industries as well as proven to be vital for effectual therapeutic protein development. Though, these techniques are well documented, but, there is scope of addition to current knowledge with novel and new approaches and it will pave new avenues in production of recombinant microbial and non-microbial proteins including secondary metabolites. In this review, we have focussed on the recent development in clone selection, various modern fermentation and purification technologies and future directions in these emerging areas. Moreover, we have also highlighted notable perspectives and challenges involved in the bioengineering of such proteins, including quality by design, gene editing and pioneering ideas. The biopharmaceutical industries continue to shift towards more flexible, automated platforms and economical product development, which in turn can help in developing the cost effective processes and affordable drug development for a large community.
Highlights
Commercial production of recombinant therapeutic proteins including monoclonal antibodies is one of the therapeutic areas that have undergone remarkable improvements with the implementation of various novel technologies over the last decade or so
Escherichia coli has been proven as a best expression host for the production of non-glycosylated proteins as it offers various advantages over yeast and other expression systems due to its well-understood genetics, cell biology, easy handling and simple upstream process (USP) which allows production of cost-effective large quantity of recombinant proteins
This review summarizes the innovative approaches in cell line development, upstream and downstream processes including use of a single-use holistic process and facility for efficient bacterial, yeast and mammalian based recombinant product development
Summary
Commercial production of recombinant therapeutic proteins including monoclonal antibodies (mAbs) is one of the therapeutic areas that have undergone remarkable improvements with the implementation of various novel technologies over the last decade or so. With the advent of high throughput screening devices such as Mini-bioreactor it has become easy to perform all screening work including process optimization at very small scale Use of such advanced microbioreactor system allows a potential time and cost savings involved in microbial fermentation process development for large scale recombinant protein production (Gupta and Shukla, 2015). S. cerevisiae Clone Development For clone development in yeast S. cerevisiae, single-copy and multi-copy vectors have been established for decades for potential use as an expression plasmid to produce recombinant proteins When these vectors are transformed in yeast unlike the E. coli system the desired genes are stably integrated to the host genome and provide stable cell line for commercial large scale protein production. In a KO, the gene is not transcribed at all, while in Knock-in, part of any gene inserted at the site-specific which
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