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    R&D Team

    Lakestar's R&D team is composed of key scientists from US and Canada, and Chinese young talents. The team understands the concepts of global pharmaceutical development, and most of the team members are the veterans in CRO and CDMO businesses. Lakestar focuses on the syntheses and development of manufacturing technologies of small molecular drug and drug intermediates. Lakestar has developed manufacturing processes for more than 100 APIs of new drugs and off-patent drugs, and have solved many manufacturing related issue, such as safety, quality, robustness, impractical to scale-up, process deficiency, patent infringement, etc.
  • R&D team has a total 20 laboratories

    10 Chemistry labs

    4 kilo labs

    One analytic lab with 20+ imported instruments

    One QC lab

    One lab for polymorph and final form

    One formulation lab

    One stability lab

    One cGMP suite for kilogram production

  • Lakestar has advanced analytical instruments, and well trained analysts. The instruments include

    11 HPLCs (8 Shimadzu; 2 Agilent; 1 ThermoFisher)

    3 GCs (Shimadzu )

    LC-MS (Agilent)

    NMR (400 MHz Bruker)

    2 balances (1 Mettler, 1 Sartorius)

    3 KFs (1 Metrohm, 2 Hogon)

    1 DSC (Netzsch)

  • Analytical team can conduct most API-related tests

    Method development, validation, and transfer

    Stability and stress testing

    Qualification of reference standard, testing and releasing of API and intermediate

    Study and define quality spec for API and intermediates; prepare CMC documentations

  • Lakestar's quality system includes

    100 SOPs based on ICH Q7

    ISO9001 certification in the Anqing site

    Passing audits of many pharmaceutical and biotech companies

    One cGMP suit, capable of manufacturing multi-kilo APIs, used for Phase I and Phase II trials