Kindos provides a comprehensive CRDMO service that meets global regulatory market requirements. This includes high-standard global filing and commercialization, covering small molecule sterile injections and biopharmaceuticals. Our one-stop service supports both domestic and international clients in accelerating development in the innovation sector while ensuring the continuous provision of high-quality medications for patients in the major disease areas.
The comprehensive application of isolation technology includes material dispensing isolators, formulation isolators, filling isolators, lyophilization loading and unloading isolators, and sterility testing isolators. Fully enclosed isolator technology provides a safe and reliable aseptic environment by isolating operators from sterile drug products. It effectively prevents human errors and cross-contamination risks, significantly enhancing operational safety and reliability. Our isolator technology meets OEB5 standards and facilitates quick product changeovers.
Mastery of advanced formulation technologies, including complex liquid preparation processes and low-temperature, oxygen-free filling techniques. The key production processes utilize proven automation and process control technologies, including online CIP, SIP, IPC weighing, online environmental monitoring, fully automated lyophilization loading and unloading, fully automatic visual inspection and packaging systems, to comprehensively ensure product quality.
The platform includes vials, cartridge bottles and pre-filled syringes. The product types encompass liquid and lyophilized injections, cytotoxic and non-cytotoxic drugs, as well as terminally sterilized and non-terminally sterilized formulations. The vial production line spans from 2mL to 100mL capacities and includes lyophilization capabilities ranging from 0.5 to 40 square meters, compatible with disposable and stainless steel liquid filling systems.
The drug substance production line is equipped with 200L, 500L and 2,000L disposable production and purification systems. Our technical teams for upstream cell culture, downstream purification, and process development have over 10 years of experiences in commercial-scale production and drug substance process development.
