• lizabethParker posted an update 2 months, 3 weeks ago

    Originally published as [Hot!] Kangri Baiao Successfully Completed 50 L to 2000 L Partner Project Production February 2022, Suzhou Kangri Baiao has completed the partner 2000 L clinical phase II sample production project in December 2021, which is directly enlarged from 50 L to 2000 L, which not only indicates that Kangri Baiao has the ability to provide clinical sample preparation and commercial production services of biopharmaceuticals to global partners, but also as a CDMO with rich experience in scale-up production. Kangri Baiao has the best practice in balancing the efficiency of technology development and the cost-effectiveness of time. The project was transferred from the pilot test of 3 L process to the pilot test of 50 L, and finally directly scaled up to 2000 L for commercial scale production. The expression level, yield and key quality indicators of products at different scales are highly similar, which realizes efficient process transfer and successful scale-up production. The growth curve of upstream cells was highly consistent with the small-scale test, and the expression level and the quality of harvest liquid met the requirements. The yield of each downstream step is consistent with the small-scale test scale, while meeting the expected requirements, and the key quality indicators of the final product have achieved high standard requirements. Figure 1: Comparison of the density and viability of 3L, 50L and 2000L viable cells Scaling up has always been a delicate process with various risk factors. For each stage of the scale-up process, analytical tests must be performed in accordance with regulations and transferred analytical methods, and risk analysis and transfer confirmation of key process parameters must be performed to ensure that the process can be validated. At the same time, the technology transfer team needs to maintain continuous communication with partners on project details to ensure that the transfer process achieves a deep understanding of process characteristics, as well as the expected requirements of process and product quality. Figure 2:2000 L reactor production Expand the full text Kangri Baiao team members have helped many well-known companies at home and abroad successfully transfer, enlarge and produce 2000 L clinical and commercial products, including many batches of production projects with high technical difficulty, which are directly enlarged from 3 L to 2000 L, with a success rate of 100%. Team members are well versed in how to effectively integrate cell culture, harvesting and purification processes in process scale-up production. The success of this case once again proves the ability of the team. We have a complete clinical stage process characterization technology platform, ,jacketed glass reactor, and have determined the process scale-up process, established the corresponding scale-down model for the mainstream reactor system in the market, carried out multivariate experimental design according to the medium and high risk parameters affecting the key quality attributes of the product, and based on the clinical phase II and III process characterization. Determine a scientific and reasonable design interval for the process parameters of commercial scale production, and formulate technology transfer, process development and scale-up production plans according to the uniqueness of different partner projects. We have transited from accumulating sufficient data and experience to making technological breakthroughs in a forward-looking manner and providing matching services for partners’projects in an agile and efficient manner. In the scale-up production project, the technology transfer team and the project management team adhere to the “full cycle” thinking, and our pursuit of quality and optimized service is reflected in every process development and production link from cell line construction to commercial production. Dynamically consider the overall needs of customers and help partners avoid potential risks. Kangri Baiao landed 2000 L disposable bioreactor in 2021, passed the quality audit of the European Union, obtained the Pharmaceutical Production License, and continuously optimized the construction of quality system, accelerated the operation of document data, and built “high-quality productivity”, at the same time, it has successfully helped many partner projects to obtain China. Clinical approvals from Australia and Europe are expected to empower more excellent partners in the industry. About Kangri Baiao Kangri Baiao Biotechnology (Suzhou) Co., Ltd. is a professional biological drug CDMO. The company’s service scope includes cell line development, process development of bulk solutions and preparations, analytical method development, formulation development and cGMP production of bulk solutions and finished products.
    The team members are all experienced senior people in the biopharmaceutical industry and have a deep understanding of the CMC field of biopharmaceuticals. Their rich experience in leading biopharmaceutical R & D and manufacturing enterprises in the industry is the key to the rapid establishment of Kangri Baiao and the provision of high-quality services to customers. It has successfully helped many partner projects to obtain clinical approvals in China, the United States, Australia, Europe and so on.