— Safety, quality, manufacturability and cost, is at the helm when designing optimal routes for customers' project needs
Data and Mechanism Supported Reaction Optimization
— Optimization work is often performed in Easymax equipment– a superior alternative that provides more accurate, higher-quality data.
— Crystallization process development and form characterization: solubility data through crystal 16
— Impurity formation mechanism, Impurity profiling and characterization, fate and purge study
— Design of Experiments: Perform Design of experiment (DOE) for evaluation the impact of CPPs (critical process parameters) on cQA (critical quality attributes)
Scale up
— GMP production up to 250L reactor or 10-20 kg batch size. Leverage manufacturing capability in China site to scale up key intermediates for increased speed and reduced overall cost
Equipment
01
Synthesis Station
EasyMax x 2 Mya 4 x 2
02
Reaction Safety
TGA (Seiko) DSC (TA) ARSST Fauske
03
Reaction Scale up
JRLs (1Lx 2L) Buchiglass Chemglass reactors x14 Buchi reaction system (250L) Huber Chiller x 6 Jilabo Chiller x 1 Gas Scrubbers x2
04
Reaction Workup
Rotoary Evaporator 20L Filters: Nutsche DN450/100L Tray Drying: Shel-Lab x 2 Grinding Mill, IKA Jet Mill (MC Dec jet 100) Certified Class D Clean room
05
Hydrogenation
High Pressure Parr (0.25-1L) Parr 50 mL shaker Micropacked bed reactors x 2 Buchi 30L Hastelloy 200 psi