As a leading Contract Development and Manufacturing Organization, Jubilant Biosys helps companies to transition swiftly from preclinical drug development stage to clinical stages with flexible and strong scale-up capabilities.
We are dedicated to providing you with comprehensive solutions for preclinical & clinical outsourcing to ensure the well-integrated execution of your projects into the clinical phase.
Process Research & Development
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
- Chiral Separations
- Stereo Selective Synthesis
- Low Temperature Reactions
- High Vacuum Distillation
- Bio-Transformation
- High Pressure Reactions
- Doe Application
- Process Intensification
- Aromatization
- Alkylation/ Methylation
- Oxidation / Chiral Oxidation
- Reduction / Chiral Reduction
- Stereo Selective Hydrogenation
- Hoffmann Bromide
- Metal Cyanide
- Fluorine Exchange
- Pressure Hydrogenation
- Amination & Dealkylation
- Prins Reaction
- Reformatsky Reaction
- Bischler-Nepieralski Cyclization
- Chiral Oxazolidinone Formation
- Selective Otosylation
- Formation of Chiral Bromohydrin
- Williamson Ether Synthesis
- Leuckart Reaction
- Pinner Reaction
- Butyl Li Rxn (Up to – 80°C)
- Quaternization
- Grignard Rxn
- Beckmann Rearrangement
- Mannich Reaction
- Claisen Condensation
- Transesterification
- Diazotisation
- Nitrations
- Gewald Reaction
- Witting Reaction
- Doebner- Knoevnagel
- 1,3 Dipolar Cycloadditions
- Anhydrous Hf Fluorination
- Inorganic Fluoride Fluorination
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/cm2 pressure)
- Rotavapour
- Fluid Bed Drier
- Spray Dryer
- Lyophilizer etc.
- Micro Reactors (Labflo and pilot)
- Plug Flow Reactors
- LC HRMS
- NMR
- XRD
- LC-MS/MS
- Ion Chromatograph
- Particle size analyzer
- Optical microscope
- Stability chambers
- Polarimeter
- FT-IR
- DSC
- GC-MS
- ICP-MS
- Prep-HPLC
