Creative Biolabs has announced a strategic upgrade of its biosimilar development services, strengthening capabilities in physicochemical characterization and biological activity comparison. The company aims to help pharmaceutical firms demonstrate that their biosimilar products are highly similar or statistically equivalent to reference drugs.
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 is highlighting its advancements in developing biosimilar pipelines, which cater to the largest and fastest-growing sector of the monoclonal antibodies market. Currently, the development catalogue covers analogues of globally best-selling drugs such as Rituximab, Trastuzumab, and Adalimumab. "We not only offer off-the-shelf solutions, but we try to solve discrete technical challenges," the researcher explained. "For example, for the analogue of Bevacizumab, we use proprietary high-expression cell line construction technology to significantly increase production and optimize downstream purification processes to remove trace impurities."
To break down barriers between research and commercialization, Creative Biolabs provides a one-stop CDMO solution with highly flexible production support. This platform supports monoclonal antibodies, bispecific antibodies, ADC drugs, and viral vectors. The CDMO platform includes cell line development using CHO and HEK293, upstream process support from 50L to 2000L, downstream process involving advanced purification techniques, and quality control aligned with GMP standards.
"Many partners performed well in the pilot stage but encountered yield reduction during scale-up," the researcher added. "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."
