Pharmaceutical Technology - May 2022

Pharmaceutical Technology- May 2022

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Page 36 of 63

36 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Continuous Manufacturing T he evolution of technologies on the bioprocessing front is enabling an ability to perform continuous processing for biologic production. Although successes have been shown at small scale, challenges arise when translating continuous processes to large-scale good manufacturing practice (GMP) level. With the help of technological advances and innovative thinking, however, the potential to implement GMP-scale continu- ous bioprocessing is getting closer to reality. Converting batch to continuous The objective with continuous manufacturing (CM) is to intensify the processes, said Jean-Marc Bielser, associate director, process technologies, MerckSerono, in a recent discussion on how Merck- Serono implemented a change to CM in its effort to address future challenges in biomanufacturing (1). Bielser pointed out that on the upstream side, CM is done by perfusion cell culture, and on the downstream side, CM involves the use of parallel operations, such as multi-column capture and f lowthrough technologies. The key goal with CM is having a process that can accelerate the bioprocessing workf low without compromising quality. According to Bielser, MerckSerono's strategy for the future is to come up with or propose novel ways of production that will be more flexible to allow it to address pipeline development. The company has facili- ties with batch manufacturing operations but is trying to implement continuous technologies in a step-wise fashion for some of the batch steps. In particular, the company developed a concept for continuous Implementing Continuous Bioprocessing: From Theory to Practice Feliza Mirasol The struggle to implement continuous biomanufacturing at GMP level is slowly advancing. TASHATUVANGO - STOCK.ADOBE.COM

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