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The Syntegon subsidiary Pharmatec is launching its new Modular Bioprocessing Platform (MBP). Developed to address pressing current challenges in biopharmaceutical production, the MBP is a flexible, fully integrated, and automated solution for biologic drug substances. The platform can be configured for a full range of microbial and mammalian cell culture applications including proteins and peptides, oligonucleotides and plasmid DNA, as well as whole or sub-unit recombinant vaccines. The modular design aims to deliver shorter lead times and lower costs without compromising on functionality or the accustomed ‘made in Germany’ quality.
Shorter times to production
Integral to time to market in today’s biopharmaceutical industry, the need for enhanced functionality and compliance in manufacturing operations has never been greater. “Biopharma companies are under intense pressure to bring increasingly sophisticated production capacity online in ever-shorter timelines,” says Christian Lavarreda, global product manager at Pharmatec.
Featuring a prefabricated integrated cleanroom design with all peripheral technology outside the cleanroom in technical skids, the MBP approach to cell culture offers full functionality off-the-shelf for clinical and commercial production alike. For example, the precise temperature control for all integrated vessels is supplied from the technical area, for a new maintenance concept. The platform also includes seamless interfaces for reusable and single-use ancillary systems, including sampling. Pharmatec, an aseptic processing specialist, included a hygienic design with sealed interfaces for the fermentation system. In addition, the MBP is operator friendly with multiple well-placed HMIs. Recipe configuration, selection, and execution, as well as the monitoring of all critical process parameters, are designed for ease-of-use.
Efficient scale-up and lifecycle sustainability
Modular hardware and automation frameworks, as implemented in the MBP, are fundamental to the advanced control strategies that are necessary for improved process characterization and successful tech transfer. The scalability of the MBP is highly resource-efficient, facilitating an optimized scale-up from clinical to commercial production. Advanced analytical functions like predictive product quality assessments and comprehensive production line analyses enable biopharma manufacturers to continuously optimize their production processes.
Meeting the highest hygiene, safety, and sustainability standards was a focus during development, which is supported by the integrated and fully automated cleaning in place (CIP) and filter integrity testing (FIT) functionalities. Pharmatec notes it is committed to the sustainability of its equipment along its entire lifecycle and will continuously add new and improved functions and options. The modular concept allows for the addition of functionalities or capacity quickly and efficiently in the future.
