R&D & Production Suzhou Lakestar PharmaTech Co., Ltd.

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

R&D Team

R&D team has a total 20 laboratories

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

Analytical team can conduct most API-related tests

Lakestar's quality system includes