Chime Biologics Announces a Cooperation with Cytiva on GMP-2 Project
- Chime Biologics has agreed with Cytiva, a globally advanced and modular biopharmaceutical factory that sets international standards, to obtain process equipment, personnel training, as well as manufacturing materials and consumables for the GMP-2 expansion project from Cytiva.
- At GMP-1 Project with the KUBio Plant of Cytiva, Chime Biologics has completed the GMP manufacturing of 70+ batches of drug substances.
- Cytiva will help Chime Biologics to complete the commercial manufacturing of COVID-19 therapeutic antibody for Humanigen, Inc. (hereinafter referred to as “Humanigen”) with the industry-leading modular disposable biopharmaceutical factory (KUBio).
October 15, 2021, Chime Biologics reached an agreement with Cytiva, a global life science pioneer, to obtain a total solution for the GMP-2 expansion project. Through the second cooperation between the two following the cooperation on KUBio, a modular biopharmaceutical factory, in 2016, Cytiva will provide support for Chime regarding process equipment, personnel training, supply of manufacturing materials and consumables to continually drive the development of the CDMO. As another milestone, the collaboration fully demonstrates the two companies’ vision to serve the biopharmaceutical enterprises together through continuous and in-depth cooperation, integrating of each other’s advantages.
Chime Biologics has completed the GMP manufacturing of more than 70 batches of drug substance with Cytiva’s total modular biopharmaceutical solution KUBio, proving the stable manufacturing capacity of the solution that balances flexibility and efficiency, as well as our comprehensive quality management system and safe manufacturing standards. As a global advanced and modular biopharmaceutical plant in line with international standards, the factory complies with ICH, FDA, EMA and NMPA standards, has been granted a Drug Manufacturing Certificate by the Drug Administration of Hubei Province, and has passed the ISO14001:2015 and ISO45001:2018 certifications internationally. With the advanced equipment, internationally renowned expert team, and standardized management system, this will be a lasting driving force for the vigorous development of China’s biopharmaceutical industry.
As an innovative “turnkey project” biopharmaceutical solution applied with advanced technology and ready-to-use bioprocess facilities in the industry, KUBio greatly reduces the project construction time and cost, facilitates to accelerate the development of biopharmaceutical industry in China through the advanced process and manufacturing flexibility in line with international cGMP standards. Taking the KUBio of Chime Biologics as an example, it consists of 62 modules and took only 18 months from manufacturing to assembly, which is far less than the time required for the construction of a traditional plant, thus helping Chime Biologics accelerate the manufacturing and marketing of biopharmaceuticals.
The process and manufacturing capacity of KUBio have also been recognized by Humanigen, a US-based biopharmaceutical company. Humanigen has entrusted us to manufacture the drug substance and finished product of its lenzilumab, a candidate for the treatment of immune overreaction known as “cytokine storm”. It will be marketed in Europe, UK, India and Brazil after regulatory approval and obtaining the marketing authorization. As the first overseas CDMO partner of Humanigen, we promise to provide at least a capacity of 56,000 liters per year for Humanigen.
Yu Lihua, General Manager of China, Cytiva, said, “China’s biopharmaceutical industry is growing at a rapid pace, and it has become an increasingly important part of the global supply chain. Cytiva is committed to enabling the sustainable development balancing flexibility and stability for local industrial chain through advanced biopharmaceutical processes. The partnership with Chime Biologics also embodies Cytiva’s philosophy of ‘In China, for China’. In the future, Cytiva will continue to provide Chinese customers, including Chime Biologics, with more diversified technology and equipment to assist in all the links of biopharmaceutical industry.”
At Cytiva, our mission is to advance and accelerate the development of therapeutics. With nearly 16 000 associates in more than 40 countries, we’re driven to use our expertise and talent to achieve better flexibility, capacity, and efficiency for our customers. Our broad and deep portfolio of tools and technologies, global scale, and best-in-class service provides critical support from discovery to delivery, for customers spanning researchers, emerging biotech, large-scale biopharma, and contract manufacturers. Learn more at cytiva.com.
About Chime Biologics
Chime Biologics is a leading CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners’ success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health.