Lktime's Mammalian Cell Expression Platform, with its diverse range of host cell lines including CHO and 293, provides a solid foundation for the R&D of innovative biologics such as mAbs, bsAbs, msAbs, fusion proteins, vaccines, and enzymes. This platform focuses on in-depth development in the field of innovative biologics and is dedicated to providing customers with comprehensive CDMO technical services spanning from molecular design to commercial production.

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LKtime's Microbial Express Platform is equipped with advanced engineered strain development facilities, dedicated to providing customers with end-to-end CDMO services from gene to IND. This platform features a diverse range of microbial expression hosts, including E. coli, S. cerevisiae, P. pastoris, and H. polymorpha, as well as customized expression vectors designed to meet client specifications. LKtime develops tailored solutions for clients by thoroughly understanding the uniqueness of each project, and ensures precise implementation through its professional technical capabilities.

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Lktime's Drug Product Platform has assembled a team of experienced professionals who have successfully completed the drug product development of multiple therapeutic protein drugs. The platform has established a GMP-compliant production system that covers the main drug dosage forms in the market, including vials (liquid injections + lyophilized), pre-filled (pre-filled syringes + cartridges), and is equipped with advanced aseptic filling production lines. The services provided span the entire lifecycle of a drug from initial research to commercialization, including formulation development, process optimization, clinical trial drug production, and post-market change management.

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LKtime's Analytical and QC Platform provides comprehensive lifecycle management support for the development of new biological products. Through close collaboration and seamless communication with various departments within the company, this platform ensures professional analytical method support at every stage. This includes target screening, developability assessment, preclinical CMC research, product characterization and quality control, CMC research during clinical phases, late-stage clinical sample production, pc/pv, and preparation of regulatory submission documents.

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LKtime's Quality and PM Platform effectively integrates three key components: Quality Assurance, Registration and Declaration, and Project Management, ensuring high standards and compliance for products and services. The Quality Assurance module monitors and enhances the quality of products and services. The Registration and Declaration module handles all submission-related matters with regulatory authorities, ensuring compliance with legal requirements. Meanwhile, the Project Management module coordinates the planning and execution of various business activities to improve efficiency and response time.

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LKtime Biotechnology (Changchun) Co., Ltd. [abbreviated as "LKtime Biotech (Changchun)"] is dedicated to providing integrated CDMO solutions for global biopharmaceutical enterprises, covering services from molecular discovery, process development, quality research, regulatory submission to commercial production. The company was established under the initiative of the Changchun New Area Administrative Committee, jointly funded by Longxiang Investment Holding Group and Shanghai LKtime Biotech, with a total investment exceeding 700 million yuan. The project spans a total construction area of 34,000 square meters, including over 20,000 square meters of GMP production workshops, making it one of the key projects in the construction of Changchun Pharma Valley.

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