Process R & D

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
  • 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/cm2 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