Genetic Engineering & Biotechnology News

NOV1 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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GENengnews.com | SEPTEMBER 1, 2018 | 9 eration equipment or sequence. Project execution needs to be rethought based on process needs, single-use materials, and automation. Soon, there will be a need for companies to have consumables (bags, filters, and transfer sets) supplied in per-batch packages based on predefined solutions plus contingency packages that include the most critical consumables for the batch. To sat- isfy this need, companies will start simplify- ing supply chains, improving logistics, and minimizing warehouse footprints to accom- modate the single-use processes. Today, the opposite is often the case. Process Automation Besides rethinking project execution, the industry needs rethink process automation, a task that must be based on digitalization, usability, scalability, and system access. The emphasis should be on bringing digitalization down to the field level by focusing on modular solutions with decentralized intelligence. This enables flexibility through the integration of intelligent package units and their respective process skids into a distributed control system (such as the Siemens Simatic PCS7 ® ) and the overall automation landscape of the bioman- ufacturing facility. The process automation system is the fo- cal point of the plant and must satisfy ISA S88 and GMP requirements for reporting, data management, user handling, auditing, and visualization. This approach will open the door for smart single-use bioproduction facilities that use electronic batch records, review-by-exception methodology, and mul- tivariate data analytics tools (such as the Sartorius Umetrics ® Suite, a data analytics platform) for real-time process monitoring, control, reporting, and release. The use of process analytical technology enables devel- opers to build quality into the product and allows operators to track how the current process compares to an optimized process— this is known as golden batch analysis. The process automation concept can also be aligned with the facility automation con- cept using an ISA S95 architecture for the environmental monitoring system as well as the building monitoring system and some in- tegration to commercial enterprise resource planning systems. Refer to Figure 2 for the ISA S95 structure that would be followed in these facilities. Partnering with a Total Solution Provider A customer that intends to carry out an overall conceptual design for a GMP facil- ity should work with an end-to-end solution provider. Such a provider can ensure that the process part of the facility will respond to the customer's needs. Besides benefiting from a total solution, one that is process-centric and encompasses technology and equipment, the customer may obtain an optimized single-use integration concept, a process layout, an over- all automation strategy, a media/buffer distri- bution concept, and an overall process sched- ule for a high-throughput facility. Once these needs around the process are fulfilled, it is then recommended to transfer these results to an engineering company, which would then focus on developing the overall facility design, incorporating elements such as quality con- trol labs, warehouse facilities, offices, HVAC (heating, ventilation, and air conditioning) systems, clean utilities, and black utilities. With this approach, companies would be able to get an overall solution (including equipment, consumables, and automation) at an optimized cost with total support and ownership of the project during the execu- tion and follow-up phases. Also, an advan- tage would be to get tested and prequalified solutions that can be easily integrated into the facility and decrease the time required from concept to performance qualification considerably. Refer to Figure 3 for advan- tages of working with an end-to-end solution provider. Ganesh Kumar is a process consultant, Michael Koch is a sales director, and Gerben Zijlstra, Ph.D., is a platform marketing manager on the Integrated Solutions team at Sartorius Stedim Biotech. Website: www.sartorius.com. Single-Use Technologies for Bioprocessing Figure 3. Advantages of working with end-to- end solution providers. Abbreviations: CAPEX: capital expenditure; COGS: cost of goods sold; PAT: process analytical technology.

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