Creative Biolabs has announced a strategic upgrade to its end-to-end biosimilar development and CDMO platform, aimed at strengthening capabilities in physicochemical characterization and biological activity comparison. The upgrade addresses the stringent requirements for demonstrating that biosimilar medicines 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 biosimilar development services and pipeline, which covers over 20 popular varieties, including analogues of top-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 added. "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 bridge research and commercialization, Creative Biolabs provides a one-stop CDMO solution supporting monoclonal antibodies, bispecific antibodies, ADC drugs, and viral vectors. The platform includes cell line development using CHO and HEK293 systems, upstream processing at scales from 50L to 2000L, downstream processing with protein A affinity chromatography and virus filtration, and quality control aligned with GMP standards. "Many partners performed well in the pilot stage but encountered yield reduction during scale-up," the researcher noted. "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."
This upgrade positions Creative Biolabs to better serve pharmaceutical firms seeking reliable biosimilar development, offering both off-the-shelf solutions and customized support to overcome technical hurdles in the path to market.
