Process development, custom manufacturing and innovative purification systems.
We offer you a unique combination of services and advanced technologies for purifying your biopharmaceuticals, from laboratory to industrial scale:
• Bioprocess development: upstream and downstream processing, fill & finish
• Outsourcing solutions: contract manufacturing services, from master cell bank to the commercial released drug product, aseptic formulation and fill & finish
• Insourcing solutions: chromatography and membrane filtration technologies, from lab to industrial scale
Solutions for Biologics Manufacturing
The biopharmaceutical industry’s objective is to bring new biomolecules to clinical trial more quickly and, therefore, reduce time-to-market. Our process expertise enables us to reduce upstream and downstream bioprocessing development lead-times using advanced methodologies, including where applicable proprietary computer modeling tools.
The biopharmaceutical industry cannot compromise when it comes to quality and patient safety. Our solutions comply with all regulatory and quality requirements. Our solutions ensure the highest quality and safety levels while optimizing purity and yield, adhering to the FDA PAT (Process Analytical Technologies) guidelines.
We have built and run our own bioproduction facilities and can bring pragmatic expertise to all disciplines including facility design, process design and development, as well as regulatory and quality requirements.
Increased Production Capacities:
With higher titres, tougher competition and increasingly stringent quality and regulatory requirements, the challenge is to align the efficiency of downstream processing to upstream titres. Our batch and continuous DSP solutions offer unique features that help develop the optimum bioprocess to match your upstream process performance.
Solutions Toward Lean Manufacturing
At Novasep , we can provide solutions for the lean manufacturing of your biopharmaceutical. Through innovative and unique products, all components of lean manufacturing are observed! Interested to learn more, please click here!
Offering for Biopharmaceutical Production and Purification
Types of biologics produced with Novasep services
We provide bioprocess development and contract manufacturing services for most types of biologics, from pre-clinical supply to commercial manufacturing.
We combine the complementary talents of chemical and process engineers as well as chemists and biologists to offer our expertise in custom manufacturing services to meet your expectations. We can produce your development cell bank with several types of cell lines (see upstream biomanufacturing services). We can develop and optimize your cell line as well as produce your biologics from clinical batches for clinical trials up to phase III with our contract biomanufacturing services.
We provide formulation and fill & finish services to offer a complete solution for your biologics production as well as complete logistic management.
We own a unique palette of DSP technologies (preparative LPLC, MPLC, HPLC, SMCC, filtration solutions) developed for biologics manufacturing.
We provide in-sourcing solutions including innovative and user-friendly biochromatography solutions (Prochrom® Biochromatography columns and Prochrom® Hipersep low pressure chromatography equipment, silica-based protein A media and Prochrom® BioSC multicolumn chromatography systems) and Tangential Flow Filtration (TFF) solutions (TangenX polymeric membranes and Kerasep® Bio mineral membranes, reusable and Sius™ single-use cassettes, TFF systems) for biologics manufacturing.