In the race to the FIH (first-in-human) trials, biologic developers need to establish a reliable manufacturing process, ensuring continuous supply of safe, effective, and high-quality drugs, at the fastest speed. Every step needs to be on the right track and there is no time to lose. This sense of urgency continues throughout the development process. High quality, high yield, robustness, reliability, and cost effectiveness all become equally high priorities, with the process forming an essential element of IND/BLA filing. With more than 20 programs of process development experience, including 7 successful commercial biologics in China, the IntellectiveBio professionals know how to transform your discovery into a drug substance. Let the biologics experts at IntellectiveBio help you, work with you to unleash the potential of your discovery and rocket your drug to clinic and market. We are as committed to your success as you are.
IntellectiveBio has a professional up-stream technology platform with comprehensive capabilities, including culture media development, cell culture process development, optimization, scale-up and characterization.
In early clinical phases, speed, flexibility, and expertise are critical for drug substance process development. Our experts apply their strong skills to significantly increase the batch yield and reduce processing time for your molecule. Meanwhile, we have the experience and capabilities to develop an optimal process with long-term commercial manufacturing in sight.
Rich CHO cell culture experience on a very broad range of therapeutic protein types: mAbs, fusion proteins, bi-specifics, tri-specifics, nanobodies, and other recombinant proteins
Multiple cell culture modes, including fed-batch, perfusion, high cell density inoculation, and concentrated fed-batch
Multiple types of bioreactors with various scales from world-leading suppliers, including:
Design of Experiment (DoE) studies to optimize target items: media/feed strategy, cell viability, titer, charge isomerism, glycosylation, sialylation, purity, HCP residue
Define the design space for process consistency and robustness by establishing the mathematics model between cell culture process parameters and critical quality attributes
IntellectiveBio property-owned cell culture media, and media customized development based on the specialty of our client’s project for manufacturing cost saving