The pharmaceutical industry faces significant challenges in developing biosimilar medicines, which must demonstrate they are "highly similar" or statistically equivalent to reference drugs. Creative Biolabs has strengthened its capabilities in this area through strategic upgrades to its biosimilar development services, focusing on physicochemical characterization and biological activity comparison. According to a chief researcher at the company, the platform now offers extensive physicochemical evaluations including primary sequence validation, high-order structure analysis, and charge variant analysis, along with cell-based functional experiments to ensure consistency in binding affinity and downstream signal transduction.
Creative Biolabs highlights its experience developing biosimilar pipelines covering 20+ popular varieties, targeting the largest and fastest-growing sector of the monoclonal antibodies market. The company's 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; for Bevacizumab analogues, proprietary high-expression cell line construction technology increases production while optimized downstream purification processes remove trace impurities.
To bridge research and commercialization gaps, 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 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 researcher noted that many partners perform well in pilot stages but encounter yield reduction during scale-up, a challenge specifically addressed through linear scale-up technology and single-use bioreactor systems ensuring process consistency from initial cloning to commercial GMP production. This approach effectively reduces regulatory risk while maintaining quality standards throughout development. The platform's comprehensive nature supports global pharmaceutical companies and biotechnology startups in navigating complex biosimilar development requirements, potentially accelerating market access for these important medicines.
