Creative Biolabs, a biotechnology service provider, has announced a strategic upgrade to its biosimilar development platform, strengthening capabilities in physicochemical characterization and biological activity comparison. The upgrade aims to help pharmaceutical firms demonstrate that their biosimilar products are "highly similar" or statistically equivalent to reference drugs, a key regulatory requirement.
A chief researcher at Creative Biolabs stated that the platform now offers extensive physicochemical evaluations, including primary sequence validation, high-order structure (HOS) analysis, and charge variant analysis. For biological activity, the company has established cell-based functional experiments to ensure high consistency with the original drug in terms of binding affinity and downstream signal transduction.
Creative Biolabs is highlighting its advancements in developing biosimilar pipelines that cater to the monoclonal antibodies market, covering analogues of best-selling drugs such as Rituximab, Trastuzumab, and Adalimumab. The company also addresses discrete technical challenges; for instance, for the Bevacizumab analogue, it uses proprietary high-expression cell line construction technology to increase production and optimize downstream purification processes to remove trace impurities. More details on their biosimilar development services can be found at https://www.creative-biolabs.com/biosimilar/.
To bridge research and commercialization, Creative Biolabs offers a one-stop CDMO solution providing flexible production support for monoclonal antibodies, bispecific antibodies, ADC drugs, and viral vectors. The CDMO platform includes cell line development using CHO and HEK293 platforms, upstream process support at bioreactor scales from 50L to 2000L, downstream process involving protein A affinity chromatography and virus filtration, and quality control in accordance with GMP standards. The company's CDMO capabilities are detailed at https://www.creative-biolabs.com/cdmo/.
The researcher emphasized that many partners perform well in the pilot stage but encounter yield reduction during scale-up. Creative Biolabs addresses this with linear scale-up technology and single-use bioreactor systems, ensuring process consistency from initial cloning to commercial GMP production, effectively reducing regulatory risk. This upgrade positions Creative Biolabs to support global pharmaceutical giants and biotechnology startups in bringing biosimilars to market efficiently.
