Continuous Processing: Is The Pharma Industry Finally Coming Round To The Idea? - Pharmaceutical Technology

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PharmTech Europe

Continuous Processing: Is The Pharma Industry Finally Coming Round To The Idea?

Pharmaceutical Technology Europe
Volume 22, Issue 9

Q. PTE: What are your predictions for the role of continuous processing in the future of pharmaceutical manufacturing and to what extent do you believe batch processing will be used?

Nepveux (Pfizer): Continuous processing will continue to be attractive for large-volume, high-throughput applications, although I think there will be a limited number of these targets going forward. I believe continuous processing will be successful where it offers quality and/or functional advantages over batch processing and we've only just begun to explore this area. Also, to the extent that cost-effective, modular continuous processing platforms can be developed for smaller-volume applications, I think it will compete effectively with batch processing.

Schoeters (GEA): We believe in a strong growth for continuous processing initially in the so-called IBC to IBC approach. Also, more melt granulation formulations will be produced using continuous technologies. Initially, the full continuous tabletting lines will be implemented and considered in specific business cases.

Weiler (SAFC): I do not believe that continuous processing will replace batch processes but it will serve as an additional tool to solve problematic cases in terms of safety, process reliability and yield. Cost cutting will be possible only if the manufacturer already has a wide range of equipment and skilled/experienced personnel in-house. Further, I think that using flow chemistry earlier on in the drug development process will significantly shorten the time to market for new API's.

Overall, I believe that greener processing, which is associated with less waste and more recovery, will mark the future of pharmaceutical manufacturing and continuous processing will have a key role to play in realising green processing. Although most continuous processes still use traditional batch work-up procedures, if the entire downstream process can be performed continuously, we will see even greater economic benefits.

Shawn Whitfield
Whitfield (Inprotech): Moving from batch-based technology to continuous processing technology is a true paradigm shift, which some companies will make quite readily as they recognise the potential benefits and advantages whilst others will take a more conservative, step-by-step approach. Undoubtedly continuous processing will be the development and manufacturing process of choice for many pharmaceutical drug substance and drug product applications but unlikely for all. I expect there will be some scientific and technological hurdles that will remain difficult to surmount for some time to come, which will necessitate a batch-based solution; although I am confident that batch processing will become the minority at some point in time.

For me, one of the most compelling justifications for switching to continuous processing is that proven systems are available that offer fully integrated, modular and/or scalable, easily portable capability, for a wide capacity or throughput range; equally as applicable to R&D and manufacturing requirements. As such, it will deliver superior product and process understanding, control and compliance, thus facilitating real Quality by Design aspirations.

Moderated by Fedra Pavlou Pharmaceutical Technology Europe

Roundtable participants Kevin Nepveux Vice President, Global Manufacturing Services at Pfizer.

Kris Schoeters Product Manager — Continuous Processing at GEA Pharma Systems nv.

Andreas Weiler Global Business Director at SAFC.

Shawn Whitfield Director at Inprotech Pharma Consultancy Limited.


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