Syntegon launches modular bioprocessing platform at Achema

Die voll integrierte und automatisierte Plattform hilft biopharmazeutischen Herstellern, schnell anspruchsvolle Produktionskapazitäten in höchster Qualität aufzubauen. / The fully integrated and automated platform helps biopharmaceutical manufacturers add sophisticated production capacity in top quality at high speed.

Die neue modulare Bioprozess-Plattform (MBP) von Pharmatec nutzt die Vorteile der Modularisierung. Sie zeichnet sich durch ein innovatives Design aus, bei dem die gesamte Peripherietechnik außerhalb des Reinraums untergebracht ist. / Developed specifically to deliver on the benefits of modularization, the new Pharmatec modular bioprocessing platform (MBP) features an innovative design with all peripheral technology outside the cleanroom.

– Innovative modular concept shortens lead times and lowers costs
– Full functionality off-the-shelf for both clinical and commercial production
– Fully integrated and automated for maximum efficiency and quality assurance

Achema 2024 has opened its doors – and visitors to the Syntegon booth are in for a surprise: the Syntegon subsidiary Pharmatec is launching its new Modular Bioprocessing Platform (MBP). Developed to address the most pressing current challenges in biopharmaceutical production, the MBP is a highly 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. “Its innovative, modular design allows our customers to profit from shorter lead times and lower costs, without compromising on functionality or the accustomed ‘made in Germany’ quality,” Christian Lavarreda, Global Product Manager at Pharmatec, emphasizes. “Biopharmaceutical manufacturers can now turn to Syntegon for seamless, complete solutions along the entire production chain.”

Innovative concept for 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. This is exactly what our new platform allows them to do,” says Lavarreda. 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, redefining the entire maintenance concept. The platform also includes seamless interfaces for reusable and single-use ancillary systems, including sampling. “The hygienic design with sealed interfaces is a clear benefit of sourcing a fermentation system from an aseptic processing specialist,” Lavarreda elaborates. In addition, the MBP is highly operator friendly with multiple well-placed HMIs. Recipe configuration, selection, and execution, as well as the monitoring of all critical process parameters, are effortless.

Efficient scale-up and lifecycle sustainability

State-of-the-art 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 seamless 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. Moreover, 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. “We are committed to the sustainability of our equipment along its entire lifecycle and will continuously add new and improved functions and options. Thanks to the modular concept, the MBP can be delivered upgrade-ready to add functionality or capacity quickly and efficiently in the future,” Lavarreda adds.

Comprehensive expertise for liquid and solid pharmaceutical processing

Apart from the launch of the MBP, Syntegon is also presenting further innovations from its broad portfolio for processing and packaging of liquid and solid pharmaceuticals at Achema. These include a cutting-edge filling machine, an inspection system with expanded capabilities, process and assembly solutions for liquid pharmaceuticals, an exemplary OSD production line for both batch and continuous manufacturing, as well as comprehensive service offerings: visitors to the Syntegon booth will obtain advice on customer and pharma services. These include, for example, service agreements, the cloud-based software solution Synexio, as well as qualification and validation services.

Syntegon will hold the following presentations as part of the congress program in hall 4.1:

– June 11, 3.30 p.m.: From paper to hardware – a technology perspective on EU GMP Annex 1 (2022); Dr. Johannes Rauschnabel
– June 12, 2.30 p.m.: Cell and gene therapies – an equipment builder’s view on current and future challenges; Dr. Andreas Mattern
– June 13, 11.30 a.m.: Towards net zero – carbon emissions from water use in pharmaceutical manufacturing; Christian Lavarreda