Cell therapy bioprocessing is undergoing significant developments at the moment. Bioprocess
engineers that have developed their skills on vaccine or recombinant protein
production will recognise the types of challenges experienced by those attempting
to manufacture cell therapies, namely, process development, innovation, operations
and process transfer, process characterization and the setting of
specifications.
Finding solutions to process
and technology cell therapy bottlenecks is the topic of a presentation at the
Cell Therapy Bioprocessing BPI Boston, Pre-Conference Symposium from invited
speaker Nick Timmins. Nick has previously co-authored a review of cell therapy
bioprocessing in BioProcess International 12(3) March 2014 entitled ‘Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence’.
Increased Sensitivity to the
Bioprocess Environment
In the review the authors describe
how cells in cell therapy bioprocesses are “biologically dynamic” and highly
sensitive to the bioprocess environment in which they are produced. This will
have a direct impact on a cell therapies critical quality attributes. In
contrast, industrial cell lines that are typically used to produce recombinant
proteins are more stable during processing and the final protein product are
less directly dependent on the culture and processing environment.
Bioprocess automation
mitigates risks in patient-specific therapy production
Bioprocessing technologies
used for cell therapy manufacture typically require a higher level of
automation which allows for a greater level of control of the bioproduction
environment which can impact product CQAs, however it also enables operators to
run multiple upstream and downstream protocols simultaneously to produce, what
could be, patient-specific therapies. The patient-specific nature of some cell therapies
adds in an additional layer of complexity to the processing requirements, not
typically found in biomanufacturing, driven by the need to prevent the
mishandling or cross contamination of patient tissues. Process automation can
help mitigate against some of these risks through ensuring the rigorous control
and identification of biological materials as they are produced. More manual process
interventions increase the opportunities for errors, contaminations and even abuse.
The BioProcess International
Conference and Exposition will be held on October 26-29, 2015 in Boston and the
Cell Therapy Pre-Conference Symposium is scheduled to take place on October 26th.
Join me at #BPIconf
Contact me at nick.hutchinson@parker.com
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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