Creative Biolabs has announced a strategic upgrade to its biosimilar development services and CDMO platform, aiming to strengthen its capabilities in physicochemical characterization and biological activity comparison. The upgrade is designed to help pharmaceutical firms demonstrate that their biosimilar products are "highly similar" or statistically equivalent to reference drugs, a critical requirement for regulatory approval.
A chief researcher at Creative Biolabs stated, "At this time, our platform offers an extensive array of physicochemical evaluations, which include primary sequence validation, high-order structure (HOS) analysis, and charge variant analysis. For biological activity, we have established a series of cell-based functional experiments to ensure high consistency with the original drug in terms of binding affinity and downstream signal transduction."
The company's biosimilar pipelines now cover over 20 popular varieties, including analogues of globally best-selling drugs such as Rituximab, Trastuzumab, and Adalimumab. Creative Biolabs emphasizes that it not only provides off-the-shelf solutions but also addresses discrete technical challenges. For example, for the analogue of Bevacizumab, the company uses proprietary high-expression cell line construction technology to significantly increase production and optimize downstream purification processes to remove trace impurities.
To bridge the gap between research and commercialization, Creative Biolabs offers a one-stop CDMO solution that provides highly flexible production support. This platform supports monoclonal antibodies, bispecific antibodies, ADC drugs, and viral vectors. Key aspects of the CDMO platform include cell line development using CHO and HEK293 platforms with high-yield stable clone screening, upstream process support at bioreactor scales of 50L, 200L, 500L, and 2000L, downstream processes involving advanced protein A affinity chromatography, ion exchange, and virus filtration, and quality control with environmental monitoring in accordance with GMP standards and a multi-dimensional quality detection system.
The researcher added, "Many partners performed well in the pilot stage but encountered yield reduction during scale-up. Our platform addresses this specifically. With our linear scale-up technology and single-use bioreactor systems, we ensure process consistency from initial cloning to commercial GMP production, effectively reducing regulatory risk."
Creative Biolabs, an international service provider specializing in biotechnology, covers antibody discovery, custom services, drug development, and CDMO production. The company provides comprehensive research support to global pharmaceutical giants and biotechnology startups.
