Research & Development
At Raybow, our experienced and innovative R&D team is focused on process development for our customer projects. This includes early preclinical stage and clinical stage, all the way to commercial stage. Our process chemists, analytical chemists and process engineers work together in their efforts to develop efficient processes that optimize manufacturing efficiency, product quality, process safety, COGS, supply chain and environmental sustainability. We strive to meet and often exceed our customer requirements.
Raybow's R&D team consists of synthetic and analytical chemists. We have 800+ high-level R&D professionals. The team is led by top international PhD scientists. We have successfully delivered over 1000 R&D projects including 600+ cGMP projects in collaboration with innovative companies from around the world. This includes many NCE-projects, submitted to Chinese, EU and US regulatory authorities.
R&D activities cover the following areas:
Process development deliverables
- Process synthetic route scouting
- Process development
- Sustainable sourcing
- Process ruggedness
- COGS optimization
The R&D team of Raybow has core proprietary technologies in the fields which incude:
- Asymmetric Ligands Platform
- Fluorine chemistry
- Flow Chemistry Platform
- Microchannel reactor technology
- Biocatalysis
The R&D team of Raybow is able to provide customers with the most professional new drug R&D solutions.
- Process Hazards Evaluation
- Critical Process Parameters and Quality Attributes
- Proven Acceptable Ranges (PAR)
- Statistical Experimental Design (DOE)
- Quality risk assessment (QRA)
- Chiral catalyst screening and optimization
- Final process definition
- Non-GMP and GMP kilo/pilot scale production
Analytical Method Research, Development, and validation
- In-Process Controls
- Raw Materials Testing
- Intermediates and Final Product Testing
- Cleaning Test Methods
- Residual Solvents
- Impurity Characterization/Detection
- Spectroscopic, Physical and Thermal Analysis
- API Reference Standard Qualification
- Method validation
- Specifications (Raw Materials, Intermediates, and Final Product)
- Release Testing
Stability Evaluation for
- Process Streams
- Intermediates
- Raw Materials
State of the art analytical instrumentation
- HPLC/VWD/DAD/Fluo/ELSD/RI/CAD (72)
- GC/FID/PFD/TCD/ECD (28)
- Ion Chromatography (Dionex ICS-1100)
- NMR (Avance III 400 MHz, Bruker)
- Prep HPLC & Semi-prep HPLC
- HPLC-MS (Agilent 6530 Q-TOF ) (1)
- UPLC/PDA (Agilent 1290)
- UPLC-MS (Agilent 6460 Triple Quad)
- UPLC-MS (Thermo LTQ XL)
- UPLC with DAD (Agilent 1290)
- GC-MS (Agilent 5975C)
- PXRD (Phaser II, Bruker)
- Auto-Polarimeter (Rudolph)
- TOC (Shimadzu )
- Air Jet Sieve Equipment (e200LS)
- ICP-MS (PE) /OES (Agilent)
- Atomic Absorption Spectrometer (AA7000)
- TGA/DSC (Mettler Toledo) & DSC (Netzsch)
- Particle Size Analyzer (Malvern 2000) (2)
- FT-IR, UV, KF, Automatic Potentiometric Titrator, EA and others