Process R&D
Our process research and development team is made up of more than 110 scientists in three research facilities: Wuhan, Tianjin, and Xiamen.
We work in state-of-the-art laboratories equipped with the latest process and analytical instrumentation. We can provide clients on-time process development service with optimization of key reaction parameters and a scalable laboratory process description, complete with process and cleaning validation.
We are also equipped for process safety assessment and calorimetric studies and can provide IND/IMPD and NDA/MAA application support. Our research and development is based on Quality-by-Design (QbD) principles.
Analytical R&D
Our Analytical R&D team comprises over 360 researchers who work closely with our process chemists to provide comprehensive analytical support.
We provide HPLC and GC method development and validation, stability studies, as well as solid and liquid characterization. Our team also works with our clients to develop methods to resolve their regulatory concerns.
Process Safety Assessment Lab
Hiray’s process safety assessment scientists and engineers can support hazard evaluation needs throughout the chemical development life cycle. From the very beginning of process development, we conduct evaluations to gain an accurate understanding of the process safety profile and anticipate potential hazards during scale-up. If necessary, we can redesign the processes to enhance the health and safety of all personnel.
The equipment in Hiray’s process safety assessment lab includes Netzsch Accelerating Rate Calorimeter, ARC 254. (specs) We also use a Mettler Toledo reaction calorimeter (specs), differential scanning calorimeter (specs), and thermogravimetric analyzer (specs)
We also deliver to our clients the following services:
Reference standard certification
Impurity separation and identification
Structure elucidation using LC-MS, GC-MS, High Resolution-Mass Spec, and NMR
Solid state / form characterization
Dissolution test
Comparative study on dissolution profiles
MSZW (meta-stable zone width) determination
Development of cleaning verification methodology
Packaging material compatibility test
Technology Transfer Laboratory
Hiray’s Technology Transfer Laboratory is a bridge connecting the laboratory to the pilot plant, ensuring successful scale-up of our customers’ processes. When fully staffed, the department will employ over 30 scientists, working in 8 independent laboratories with 83 fume hoods.
Independent laboratories and fume hoods are password-controlled for protection of customers’ intellectual property. Our experienced process and analytical chemists provide clients with process optimization, process development, and process transfer to pilot scale and support ongoing pilot plant operations.