Wednesday, September 23, 2015

Bioprocessing Cell Therapy Products Demands Greater Automation

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.

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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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