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FAQ: Creative Biolabs' Upgraded Biosimilar Development and CDMO Platform
TL;DR
Creative Biolabs' enhanced biosimilar development services offer pharmaceutical firms a strategic advantage in demonstrating product equivalence to reference drugs for faster market entry.
Creative Biolabs' platform provides comprehensive physicochemical characterization and biological activity comparison through sequence validation, HOS analysis, and cell-based functional experiments to ensure biosimilar consistency.
Creative Biolabs' expanded biosimilar development capabilities help make essential biologic medicines more accessible and affordable, improving global healthcare outcomes for patients worldwide.
Creative Biolabs uses proprietary high-expression cell line technology to boost production of biosimilars like Bevacizumab analogues while optimizing purification to remove trace impurities.
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Creative Biolabs has upgraded its end-to-end biosimilar development and CDMO platform, strengthening capabilities in physicochemical characterization and biological activity comparison to help pharmaceutical firms demonstrate their biosimilars are highly similar to reference drugs.
The upgrade helps pharmaceutical firms demonstrate their biosimilar products are 'highly similar' or statistically equivalent to reference drugs, which is a regulatory requirement, while also providing comprehensive development and manufacturing support from research to commercialization.
The platform offers extensive physicochemical evaluations including primary sequence validation, high-order structure (HOS) analysis, and charge variant analysis, plus cell-based functional experiments to ensure consistency in binding affinity and downstream signal transduction with original drugs.
Their development catalogue covers analogues of globally best-selling drugs such as Rituximab, Trastuzumab, and Adalimumab, with experience covering 20+ popular varieties in the monoclonal antibodies market.
They offer both off-the-shelf solutions and solve discrete technical challenges, such as using proprietary high-expression cell line construction technology for Bevacizumab analogues to increase production and optimize downstream purification processes.
The CDMO platform provides flexible production support from molecular design to 2000L large-scale production, covering cell line development, upstream process (50L-2000L bioreactors), downstream process (protein A affinity chromatography, ion exchange, virus filtration), and GMP-compliant quality control.
They address yield reduction during scale-up with linear scale-up technology and single-use bioreactor systems, ensuring process consistency from initial cloning to commercial GMP production and effectively reducing regulatory risk.
The platform extends to bispecific antibodies, ADC drugs, and viral vectors in addition to monoclonal antibodies.
Creative Biolabs is an international leading biotechnology service provider whose business covers antibody discovery, custom services, drug development, and CDMO production, providing comprehensive research support to global pharmaceutical giants and biotechnology startups.
The content mentions several resources: biosimilar development services, biosimilar pipeline development, and one-stop CDMO solutions.
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