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Sartorius BIA Separations
Sartorius BIA Separations develops and manufactures market-leading CIM® monolithic chromatographic columns for the purification and analysis of large biomolecules, such as viruses, plasmids, and mRNA, which are applied in cell and gene therapies.
The company’s Cornerstone® Biomanufacturing Development Services are the result of more than 20 years of hands-on experience with the most challenging biopharmaceutical products and offer a comprehensive approach of integrated process development solutions and novel technology designed to improve the robustness and yield of large biomolecules production while improving the safety of therapeutic products.
Sartorius BIA’s technology for manufacturing-scale purification is already used in the production of the first commercialized advanced therapeutics; the company also has a keen presence with novel drug candidates in the clinical pipeline.
Niba Labs is an analytical laboratory with extensive expertise in digital PCR assay development and sample testing, focused on viral vector characterization studies to addresses the analytical needs and challenges of gene therapy products by thoroughly investigating quality attributes such as vector genome titer, genome integrity and impurities.
Niba Labs experts have addressed the issue of AAV vector genome integrity by developing an advanced dPCR multiplex approach.
The team, led by David Dobnik, PhD, pioneered the development of ddPCR analytical methods and provided insights and guidance for the optimisation of the manufacturing process for gene therapy drug for SMA, the globally approved gene therapy product developed by AveXis (now Novartis Gene Therapies).
As of recent, Niba Labs is GMP certified for digital PCR analytical testing and can seamlessly support its customers all the way through product life cycle, from early stages of assay development to assay validation and release testing.