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A Look Into the Future of Bioprocessing by Dr A Look into the Future of Bioprocessing by Dr. Svea Grieb, Kai Touw and Dan Kopec The internet of things and robotics are already the working standard in fast- adapting industries. These technologies are now also being implemented in the biopharma industry, which is more conservative due to strong regulations and intrinsically complex processes. How is this change going to proceed and how does it change the industry? Does it provide a bigger benefit than its risk? We asked three experts for process analytical technologies, automation and data analytics from Sartorius about their view on the future of bioprocessing. Advantages of Next Generation Manufacturing We would first like to discuss the main advantages of implementing Process Analytical Technology (PAT) and advanced data analytics, which enable automation of bioprocesses. This allows for the production of higher quality and more consistent biologic drugs and regenerative therapies at reduced costs of goods (CoGS), with higher flexibility and faster time to market1,2. We consider the five main advantages of the implementation of PAT, automation and data analytics to be the following: Consistent, High Product Fast and Predictive Account for Cell Variation Quality Up- and Down-Scaling from Different Sources Consistency in product quality A well characterized and The field of personalized and quantity is achieved, as monitored process together medicine benefits greatly from variations of critical process with scalable hardware can automation. In regenerative parameters (CPPs) are reduced significantly reduce the cost medicine applications, the and process robustness is and efforts of process scale autologous nature of the increased. This is summarized up | down, as scale variations treatment demands a process in figure 1. can be accounted for in an that is flexible, and can automated and predictive dynamically adjust to wide fashion. variations in starting material. Reduced Risk of Lost PAT can account for the Batches and Increased variations and peculiarities of Freeing up Operators Process Safety the cells from different patients in an automated fashion. Advanced Automation reduces Reduced risks of operator errors This result in a high process the requirements of operator and of contamination through consistency irrespective of interference, which on the manual sampling. The timely the starting material. identification and correction of one hand reduces the risk of process irregularities reduces operator errors, and on the the risk of lost batches. other hand allows the operators to focus on other tasks. Traditional Process: Post-Process Quality Testing Fixed Fixed Fixed process process process Variability in product quality and Post-process testing of quality to ensure product is within quantity specification before the release of the stage PAT Process: Quality by Design Variable Variable Variable process process process Consistency in product quality and Continuous online monitoring and control of critical process quantity parameters (CPPs) that affect the critical quality attributes (CQAs) of the product Figure 1: PAT and automation result in consistent, high product quality 2 Key Technologies of Next Generation Manufacturing We would like to discuss three key players of next generation manufacturing that are currently driving the change. Flexible, Automated Skids Spectroscopy Multivariate Data Analytics A technological development, We believe that spectroscopic which is key for use in down- techniques will become more The application of sophisticated stream processes are flexible abundant in both upstream and PAT tools in combination with automated skids, capable of downstream bioprocessing, due multivariate data analytics has handling different type of unit to its capability of label-free, a high impact on commercial operations, all based on S88 online measurements of several processing. Measurements are compliant recipes. These type analytes, cell properties and moved forward in the process of process skids make it product quality attributes. to the point of controllability. possible to run standardized Hence, spectroscopy has the Using process fingerprints, and automated processes potential to replace offline the state of the process can in facilities making use of measurements during the be assessed at any time. a ‘ballroom’ concept. bioprocess. We envision the use Furthermore through real-time of a combination of different univariate and multivariate spectroscopic techniques, such process monitoring, data can as NIR, Raman and UV-Vis to be used for simulation and be required for this. That said, modelling of process design there will be a continuing need and control and ultimately lead to use and further develop to prescriptive analytics of other technologies, such as product quality. bio-capacitance, and dedicated nutrient | metabolite sensors, for application for which spectroscopy does not provide a solution. Furthermore, to propagate the use in GMP, we envision a combination of sensors which crosscheck each other. 3 On the Challenges of Next Generation Manufacturing When speaking about automation of bioprocesses, we need to evaluate technical feasibility and cost-benefit analysis. Furthermore, there are regulatory, logistics and safety issues that have to be solved before automation can really be adopted widely in the biopharma industry. Processes Challenging be established. Further, there is technical advances in the field to Automate the challenge of aligning the of automation, PAT and ad- process automation concept vanced analytics, as is shown by While we do not think that of a supplier to the facility the creation of the ‘Emerging there is an application in the automation concept in terms Technology Program’ by the process of biopharmaceutical of environmental monitoring, FDA3,4. drug production that would building monitoring and not benefit from automation a certain level of integration at all, we do not envision that into resource planning systems. IT Concerns | Data Integrity we will see a high degree of A comprehensive automation automation added to already Regulatory Challenges strategy for an entire biopro- existing pipelines, such as cess, and potentially an entire well-established fed-batch Some concepts of modern production site, requires processes. Unless, of course, the automation technologies and connectivity of all components automation adds a significant sensor technologies are not yet and a centralized control unit. improvement to the process, as covered by regulatory guide- However, that would require we have seen it for automated lines. This is especially true for data sharing and access that im- temperature shifts at a certain multivariate data analysis that plies safety risks. We experience viable cell density, for example. takes all available data and inte- reluctance among our custom- Further, there are processes grates them into a fingerprint. ers to adopt new technologies that are possible to automate The adoption of such batch- such as cloud computing and but do not benefit massively fingerprinting concepts must wireless communication of from the automation, as be considered by the regulatory PAT components. the manual interference is bodies. The same questions very limited, such as dead-end arise for multi-analyte sensors We are convinced that the task filtration. Finally, there are that are based on computation- of meeting the requirement of processes that will be quite al models, as it is the case for next generation manufacturing challenging to find an automa- spectroscopy, for example. in terms of hardware, software, tion for. Product quantification How do we validate a model for data analytics and infrastruc- with a background of many the use of GMP? What are the ture is too demanding and other proteins could be one characteristics of a ‘good and complex to be addressed by just such example. robust’ model? These questions one supplier. It requires the have to be addressed. A last collaboration of several indus- Compatibility and case we want to mention is the tries in strong exchange with definition of ‘a batch’ for con- the customers to guide new Infrastructure Challenges tinuous processing. Regulations developments. Sartorius has The seamless integration that were once established realized this need, as reflected of process equipment and for a 2-weeks process have to by the integration of Sartorius be adjusted to processes that Stedim Data Analytics process skids into the automa- ® tion system, especially when can potentially run for months (former Umetrics ) and the considering flexible manufac- without interruption. The Regu- collaboration with Siemens turing facilities, is an issue. latory Agencies are well aware for our newest automation Communication between of the challenges which come platform NewAP. competitor solutions is not with modernizing the industry, always given and there is a lack but are open and cooperative of standards that still need to to new concepts coming from 4 On the Potential of Next Generation Manufacturing We expect the upstream processes to benefit the most from automation, due to the highly variable nature of the biological process. A higher degree of automation and standardization of the process steps will lead to improved batch-to-batch consistency, and in turn, product quality. There are three application areas that will benefit the most from automation and therefore drive the development of PAT integration and advanced data analytics. Intensified Processing | Viral Processes Cell
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