Jubilant Biosys, a subsidiary of Jubilant Pharmova, is a leading contract research, development and manufacturing organization in India and provides innovative development and manufacturing solutions to the global pharmaceutical industry.
As global CDMO partner, Jubilant Biosys offers unique and specialized support for effective transition from the medicinal chemistry phase to early scale-up without taking more time than absolutely necessary. Biosys has set-up a dedicated PR&D team, non-GMP & GMP Kilo lab, GMP pilot-scale and dedicated commercial manufacturing lines which provides a strong foundation for rapid scale-up and delivery of key milestones for your contract development and manufacturing programs.
Services Offered under CDMO:
A. Process Research & Development Capabilities
- Route scouting, evaluation, finalization (Linear to Convergent) & Proof-of-Concept (PoC).
- Salt & Polymorph screening.
- Tech Transfer, GLP / non-GMP, cGMP material supplies for Tox, Preclinical, Phase I-III.
- Process design, development and optimization.
- Process safety studies.
- Development & management of complex multi-step synthesis of APIs having many chiral centers, Chiral separations. Stereoselective synthesis, Low temperature reactions, High Vacuum Distillation, Solid form development- salt and polymorph studies, Bio transformation. High pressure reactions (hydrogenerators, reductive animation etc.), Process Intensification (continuous flow reactions) DoE application, Data generation for process safety evaluation, Kilo Lab(Capacity — 5,10 & 20L, heating range @2000 C& cooling range @-500.
B. Process Research & Development-Analytical Capabilities
- Method development.
- Nitrosamines method development & validation.
- Documentation as per GLP/FDA requirements for Technology transfer.
- Polymorph characterization.
- Forced degradation studies & development.
- Stability studies as per ICH.
- Centre of Excellence (CoE-Solid State Chemistry).
- Genotox potential evaluation.
C. Scale-up:
a. Non-GMP Scale-up [Site: Noida, Delhi, Capacity: upto 20 Kg]:
- Route scouting, process design and optimization.
- Salt screening and polymorph studies.
- Experience: 40 Clients catered in past 3 years, 153 Projects completed in past 3 years & 10 Scale up NCE (Up to 20kg).
- Synthetic demonstration scale-up manufacturing.
- Infrastructure: Scale-up hoods to accommodate multiple 20L reactors, 20L jacketed reactors with TCU, Multiple centrifuges & Nutsche filter and Multiple Rotavapor of 20L and 50L capacity.
b. GMP Kilo Lab [Site: Nanjangud Pilot Plant, Capacity: 100g – 1 Kg]:
- Low volume clinical trial APIs.
- Instrumentation: 10L, 30L Hastelloy reactors, 10L All Glass Reactors, Independent Temperature Control Unit & 5L Nutsche filter and 2 tray VTD.
- GMP trials & validation.
c. GMP Scale-up [Site: Nanjangud Pilot Plant, Capacity: 1Kg – 20Kg]:
- Different variety of reaction vessels including a coil reactor for continuous reactions.
- Filtration: Centrifuge/Nutsche Filter/Pressure Nutsche filter/ Agitated Nutsche filter & dryer.
- Milling & Size reduction: Air Jet Mill/Multi mill/Sifter Absorption: Scrubber for hazardous fumes.
- Distillation: Batch distillation, Atmospheric, Azeotropic high vacuum distillation.
- Drying: Vacuum Tray Dryer/ Agitated Nutsche filter & dryer/RCVD/FBD.
- Infrastructure: Capacity: 4.3KL, 23 reactors, 2 stream of clean rooms and 200 ml coil reactors.
d. High volume GMP Scale-up:
- State of the art manufacturing facility with 750 KL + capacity.
- Best in class quality control lab, Equipped with latest equipments like LC HRMS, NMR, XRD, LCMS, GCMS, ICP-MS, etc.
- Each plant is supported by centrifuge, rotary & agitated filter and Air Jet Mill.
- Facility is divided in 6 plants equipped with stainless steel, glass, Hastelloy & Hydrogenators reactors.
- Availability of Fluidized Bed, Rotocone and Vacuum dryer in each plant.
Instrumentation:
- Process Research: Reaction Calorimeter, BRM Lasentec, Autoclaves (SS & Hastalloy up to 100 kg/cm2 pressure), Fluid Bed Drier, Spray Dryer, Lyophilizer etc, Micro Reactors (Labflo and pilot), Plug Flow Reactors.
- Analytical: Prep HPLC, UHPLC-MS & UPLC-MS, UPLC-HR-MS (Acquity RDa), HS-GC-MS, Analytical SFC, Preparative SFC, HPLC, NMR, DSC, ICP-MS, Ion chromatography (IC), FT-IR, Polarimeter, KF Titrator, LC HRMS, XRD, LC-MS/MS, Particle size analyser, Optical microscope, Stability chambers.
Why Jubilant Biosys CDMO:
- Established 6 Centre of Excellence in Chemistry: PROTAC, SPPS & Carbohydrate Chemistry, Lipids, Photoredox & Electrochemistry, Solid State Chemistry, Library Synthesis.
- In-house repository for Scaffolds, Building Blocks, Intermediates, Reference Compounds.
- Regulatory affiliation of manufacturing facility from US FDA, EDQM, Health Canada, AFSSAPS France, PMDA, TGA, MFDA Korea, ANVISA Brazil, & COFEPRIS Mexico.
- Customised scale-up support ranging from 100g to multi-tons.
- World class cGMP manufacturing facility with 6 plants (multi-ton volume), pilot plant (<20 Kg) and a kilo lab (< 1 Kg) with a total capacity of 750 Kl.
