Creative Biolabs has announced a strategic upgrade to its biosimilar development services, strengthening capabilities in physicochemical characterization and biological activity comparison. Pharmaceutical companies developing biosimilar medicines must demonstrate their products are highly similar or statistically equivalent to reference drugs, and Creative Biolabs now offers extensive physicochemical evaluations including primary sequence validation, high-order structure analysis, and charge variant analysis. For biological activity assessment, the company has established cell-based functional experiments to ensure consistency with original drugs in binding affinity and downstream signal transduction.
The company highlights its development experience covering more than 20 popular varieties, focusing on the monoclonal antibodies market. Creative Biolabs' development catalogue includes analogues of globally best-selling drugs such as Rituximab, Trastuzumab, and Adalimumab. Beyond off-the-shelf solutions, the company addresses discrete technical challenges, such as using proprietary high-expression cell line construction technology for Bevacizumab analogues to increase production and optimize downstream purification processes to remove trace impurities.
Creative Biolabs provides a one-stop CDMO solution that bridges research and commercialization with flexible production support. This platform extends beyond monoclonal antibodies to include bispecific antibodies, ADC drugs, and viral vectors. The CDMO platform encompasses cell line development using CHO and HEK293 platforms with high-yield stable clone screening, upstream process support for bioreactor scales from 50L to 2000L, downstream processes involving advanced protein A affinity chromatography, ion exchange, and virus filtration, and quality control with GMP-standard environmental monitoring and multi-dimensional detection systems.
The company specifically addresses scale-up challenges that many partners face during commercialization. With linear scale-up technology and single-use bioreactor systems, Creative Biolabs ensures process consistency from initial cloning to commercial GMP production, effectively reducing regulatory risk. This comprehensive approach positions the company to support both pharmaceutical giants and biotechnology startups in navigating the complex biosimilar development landscape while maintaining quality and efficiency throughout the production pipeline.
