Tuesday, July 7, 2015

The continuous production of biopharmaceutical drugs

If there is one hot topic in biomanufacturing at this moment in time it has to be continuous processing. Journals and websites are feeding, what appears to be, the biopharmaceutical industry’s almost insatiable appetite for information on the subject. The interest is reflected in the deals made within the industry such as Pall Corporation's acquisition of the BioSMB technology platform from Tarpon Biosystems and Repligen Corporation’s 2014 acquisition of Refine Technology. Refine developed and manufactured the Alternating Tangential Flow (ATF) filtration device which can be used to retain mammalian cells within bioreactors while continuously harvesting product.
With such a focus within biopharma upon continuous processing it is no surprise that a significant portion of the Bioprocess International 2015 Conference, agenda is allocated to talks on this subject. Before we look at some of those talks in more detail, however, we should review the industry drivers that appear to be taking the bioprocess sector away from the batch process paradigm and moving it towards a continuous manufacturing future.
The four key industry drivers behind continuous bioprocessing
In an excellent article, Veena Warikoo from Genzyme, a Sanofi company, and co-workers published in 2012 on the “Integrated Continuous Production of Recombinant Therapeutic Proteins” (Biotech Bioeng, 2012;109: 3018-3029). Four key drivers are given as:
1.    the need for biopharma companies to flexibly accommodate large-volume and orphan drugs potentially within the same facility
2.    the need for production platforms to accommodate both stable monoclonal antibody and less stable recombinant protein therapeutics
3.    the need to make rapid adjustments in production capacity in line with the dynamics of market demand
4.    increasing cost pressures, not least, due to the growing pipeline of biosimilars in development
The benefits of bioprocess intensification
Warikoo and her co-authors explain that the conversion for batch to continuous manufacturing has occurred in many other industries in the past and has led to the following benefits:
1.    steady-state operation
2.    small equipment size
3.    high volumetric productivity
4.    streamlined process flows
5.    low cycle times
6.    reduced capital costs
Too conservative for continuous?
Bioproduction is renowned for being a conservative endeavour. Despite the business deals and industry drivers are we really ready for continuous biomanufacturing or is the noise in the media simply empty hyperbole? Will continuous processing become the rule or remain the exception? Join the debate by letting us know your thoughts.

Dr Nick Hutchinson
Join me at #BPIconf
Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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