Creative Biolabs Enhances Biosimilar Development and Manufacturing Platform to Address Industry Challenges

Creative Biolabs has announced significant upgrades to its biosimilar development services and CDMO platform, focusing on enhanced physicochemical characterization and biological activity comparison capabilities essential for demonstrating biosimilar equivalence to reference drugs. 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, complemented by cell-based functional experiments to ensure consistency in binding affinity and downstream signal transduction with original drugs.

The company highlights its development experience covering over 20 popular varieties, particularly targeting the monoclonal antibodies market with analogues of globally best-selling drugs such as Rituximab, Trastuzumab, and Adalimumab. The researcher emphasized that beyond off-the-shelf solutions, the company addresses discrete technical challenges, citing proprietary high-expression cell line construction technology for Bevacizumab analogues that increases production while optimizing downstream purification processes to remove trace impurities.

Through its one-stop CDMO solution, Creative Biolabs provides flexible production support extending from molecular design to 2000 L large-scale production, breaking down barriers between research and commercialization. The platform supports not only monoclonal antibodies but also bispecific antibodies, ADC drugs, and viral vectors, with key components including cell line development using CHO and HEK293 platforms, upstream processes supporting bioreactor scales from 50L to 2000L, and downstream processes involving advanced protein A affinity chromatography, ion exchange, and virus filtration.

Quality control systems feature environmental monitoring in accordance with GMP standards and a multi-dimensional quality detection system. 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 that ensure process consistency from initial cloning to commercial GMP production, effectively reducing regulatory risk. This comprehensive approach positions the upgraded platform to support both pharmaceutical giants and biotechnology startups in navigating the complex biosimilar development landscape.