Process Chemistry

De novo route design or route improvement from existing early phase / medicinal chemistry sequences.
Novel routes to overcome toxic/hazardous reagents or solve scalability challenges.
Proactively offer strategies and ideas for collaborative project discussions.
Significant experience in extended linear and macrocyclic routes.

Optimization of existing chemical route for robustness and efficiency.
Identification, isolation and synthesis of impurities, and impurity fate mapping (including spiking).
Preparation of reference standards and intermediate and enantiomers.
Phase appropriate process design and understanding (QbD, identification of CPPs, process safety; identification of NORs and PARs to support CMC documentation).
Technology transfer of synthetic processes to manufacturing units.
Analytical method research and development.
HAZOP and process safety studies.

Eighteen process laboratories
Each lab equipped with Agilent auto-sampling HPLCs
Reactions up to a 10 L scale at temperatures of -78 o 150 degrees C
‘Chemglass’ reactors with overhead stirrers and chillers; 500 mL, 1 L and 2 L
Characterize molecules by 1D/2D NMR, MS (HR), LC/GC, XRPD, DSC, TGA and SC-X-ray*
Prep-HPLC and preparative separation of enantiomers*
Pd/C hydrogenations and Rh–diphosphine ligand asymmetric hydrogenations of α,β-unsaturated carboxyl systems (1 x 50 mL, 8 x 100 mL, 1 x 500 mL, 1 x 10 L and 1 x 20 L (Hastelloy) high pressure autoclaves for screening)

16 Mobile reactors from 30 L to 100 L (non-GMP)
30 L, 60 L and 100 L reactors in common area (GMP)
60 L reactor in class D area (GMP)
Solid containment with solid exposure OEL < 10 μg/m3 through engineering control.

Process Chemistry at Hande Sciences