Process Development-Our Services

Intellective Bio operates an industry-leading cell culture development laboratory, equipped with a range of advanced and diversified cell culture systems and analytical instruments. This establishes a comprehensive, multi-level technical support system, enabling the delivery of efficient, robust, and scalable manufacturing process solutions for clients.

The laboratory features glass bioreactor systems ranging from 2 L to 15 L, enabling precise control and optimization of critical process parameters such as pH, dissolved oxygen, temperature, and shear stress. Guided by Process Analytical Technology (PAT) and Quality by Design (QbD) principles, we gain a deep understanding of how these parameters impact Critical Quality Attributes (CQAs), ensuring process reliability and robustness. This foundation allows for robust scale-up to commercial-scale operations, including single-use bioreactors from 50 L to 2,000 L and stainless-steel bioreactors from 500 L to 6,000 L. Furthermore, we continuously explore innovative processes to enhance production efficiency.

Intellective Bio has established a professional and innovative downstream process technology platform with comprehensive development capabilities, including purification process development, optimization, scale-up, and process characterization. The platform covers seven major classes of biologics—monoclonal antibodies, bispecific antibodies, multispecific antibodies, nanobodies, recombinant proteins, vaccine proteins, and coagulation actor proteins—with 100% molecular compatibility and supports a molecular weight range spanning from 15 kDa to 1,500 kDa.

Our technical experts possess profound professional knowledge and extensive industry experience, enabling significant improvements in product quality and batch yield, shortening development timelines, and establishing processes designed for high-quality, long-term commercial manufacturing.

Intellective Bio provides formulation development services for a wide range of therapeutic proteins, including antibodies (monoclonal, bispecific, and trispecific), nanobodies, fusion proteins, ADCs, and protein vaccines. Our expert team has extensive experience in overcoming formulation challenges associated with therapeutic proteins, such as thermo-sensitive molecules, photo-sensitive molecules, and high-concentration protein formulations.