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Aparajita
Dubey summarises the recent trends in upstream bioprocessing and highlights the
challenges and solutions involved in its process development.
A
ROBUST high-yielding upstream process is a combination of powerful technology,
high-quality starting material, and a brilliant process design. Bioprocess
engineering involves understanding the conditions most favoured for optimal
production and duplicating these conditions during scaled-up production.
Safety, purity, potency, efficacy and consistency are the key features involved
in bioprocess development of recombinant monoclonal antibodies (mAbs) and other
novel drugs. The most challenging characteristic of upstream processes is the
use of living organisms, which do not always behave in an expected way.
Tremendous
progress has been made in upstream processing in the last decade, which has
resulted in the development of modern fed-batch processes capable of delivering
10g/L of mAb or more. Better cell culture media, more advanced feeding
strategies, more robust cell lines and bioreactor control tailored for specific
processes are the major pillars of upstream development that have resulted in
the overall progress made in this domain.