Pharmaceutical Technology - May 2022

Pharmaceutical Technology- May 2022

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38 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Continuous Manufacturing cell culture that is compact. In the future, the com- pany aims to establish a continuous bioprocessing system that is more integrated and that will incor- porate process analytical technology (PAT) tools that will allow for better control over all the bioprocessing steps, Bielser stated in his discussion. In their approach to switching some batch op- erations to continuous operation, MerckSerono had first to generate data showing that the continu- ous technology would work, after which the com- pany had to devise appropriate workflows. Having a proper workf low is a critical step, according to Bielser. Developing the workflow puts into perspec- tive important questions, such as, where does the company want to implement the technologies for CM, and on which processes? For MerckSerono, the company wants to apply these new technolo- gies for CM to new molecules that will come into its pipeline, Bielser said in his discussion. This requires having strategies in place for early process develop- ment, hence the creation development of workflows is important. To enable workf low development, Bielser noted that cross-functional collaboration among different company groups is important. From theory to implementation Evolving from theory to actual implementation of CM is a focus for some companies looking to move towards CM at GMP scale. In FujiFilm Dio- Synth Biotechnologies's case, part of their aim in conducting a case study on implementing CM was to bring the idea from an internal discussion to a large-scale, setting, such as going up to 500-L scale production. If CM at the 500-L scale was successful, then it would show that it is possible to make GMP material through CM, according to Morten Munk, director—Global Alliance Management, FujiFilm DioSynth Biotechnologies, in a discussion on the company's CM experience during this 500-L CM case study (2). With the study, FujiFilm DioSynth Biotechnologies learned how biopharmaceutical companies should approach moving from theoreti- cal to actual implementation of CM at scale. According to Munk, FujiFilm DioSynth Biotech- nologies employed single-use technology in the CM study. With a single-use setup, FujiFilm DioSynth Biotechnologies was able to maintain a closed sys- tem and maintain sterility. In his discussion, Munk imparted lessons learned from the CM study, including the notion that, when setting up a manufacturing system with single-use technology and for continuous processing, it is not necessarily vital that every single component or aspect need be composed of single-use technol- ogy or that the entire process need be continuous. Munk was of the opinion that a hybrid set-up can still be successful for GMP CM. This may entail a combination of single-use technology and stain- less steel equipment, or using batch processing in some parts of the system and continous processing in other parts. Having a correct balance between these aspects is important. Munk concluded his discussion with the notion that companies looking to implement CM at GMP scale should not focus soley on quota or cost, but rather focus on the quality advances and the f lex- ibility that technologies today offer that can get a company moving forward to continuous processing. References 1. Evaluating BioPharma Roundtable Series, "Implementation of a Continuous Technology Strategy to Support Therapeutic Protein Production,", Dec. 14, 2021. 2. Evaluating BioPharma Roundtable Series, "Technology Con- siderations and Challenges to Support Compliant CM @ GMP,", Dec. 14, 2021. PT

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