We have comprehensive process research and development (PR&D) and manufacturing capabilities to support the early CMC campaigns of NCE programs. These combined capabilities ensure well-integrated execution of projects into the clinical phase. PR&D Capabilities - Route scouting, process design and optimization. - Development & management of complex multi-step synthesis of APIs having many chiral centers. - Stereoselective synthesis. - Chiral separations. - Bio-transformation. - Solid form development – salt and polymorph studies. - Low temperature reactions. - High Vacuum Distillation. - High pressure reactions (hydrogenations, reductive amination etc). - Process Intensification (continuous flow reactions) DoE application. - Data generation for process safety evaluation Kilo Lab (Capacity – 5,10 & 20L, heating range @ 200°C & cooling range @ -50°C). PR&D: Technologies and Reactions - Complex Multi- Step Synthesis - Pinner Reaction - Alkylation/ Methylation - Gewald Reaction - Reformatsky Reaction - Low Temperature Reactions - Grignard Rxn - Stereo Selective Hydrogenation - 1,3 Dipolar Cycloadditions - Selective Otosylation - Metal Cyanide - Inorganic Fluoride Fluorination - Williamson Ether Synthesis - Pressure Hydrogenation - Aromatization - Nitrations - Prins Reaction - Stereo Selective Synthesis - Quaternization - Reduction / Chiral Reduction - Doebner- Knoevnagel - Chiral Oxazolidinone Formation - Bio-Transformation - Anhydrous Hf Fluorination - Formation of Chiral Bromohydrin - Doe Application - Transesterification - Leuckart Reaction - Amination & Dealkylation - Chiral Separations - Butyl Li Rxn (Up to – 80°C) - Oxidation / Chiral Oxidation - Witting Reaction - Bischler-Nepieralski Cyclization - High Vacuum Distillation - Beckmann Rearrangemen - Hoffmann Bromide - Mannich Reaction - High Pressure Reactions - Claisen Condensation - Fluorine Exchange - Process Intensification - Diazotisation PR&D: Analytical Capabilities - Method development. - Polymorph characterization reaction monitoring support. - Generation of reference / working standards. - Stability studies as per ICH. - Nitrosamines method development & validation. - Forced degradation studies & development. - Impurity profiling and structural elucidation. - Documentation as per GLP/FDA requirements for Technology transfer. - Centre of excellence for Mass Spectrometry. - Genotox potential evaluation. PR&D: Equipment - Reaction Calorimeter - BRM Lasentec - Autoclaves (SS & Hastalloy up to 100 kg/cm 2 pressure) - Rotavapour - Polarimeter - DSC - ICP-MS - Fluid Bed Drier - Spray Dryer - Lyophilizer etc. - Micro Reactors (Labflo and pilot) - Plug Flow Reactors - FT-IR - GC-MS - Prep-HPLC - LC HRMS - NMR - XRD - LC-MS/MS - Ion Chromatograph - Particle size analyzer - Optical microscope - Stability chambers
Compiled from https://www.jubilantbiosys.com
