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Integrated R&D campus for Discovery R&D, CMC process development & clinical phase manufacturing

The Integrated Discovery & Development Campus (Unit II) enables us to provide scientific solutions and supports a comprehensive suite of services, ranging from early-phase discovery, preclinical development, and clinical development, through to commercial manufacturing. This 12-acre campus in Hyderabad serves our customers globally, ensuring a seamless integration of all phases of drug development cycle.

Discovery facilities

Medicinal Chemistry highlights

  • 360+ fume cupboards, all < 3 years old
  • Each lab is self-contained with dedicated LC-MS for reaction monitoring Radleys Parallel Synthesizers, 5 CombiFlash® and other complementing infrastructure
  • Industry-benchmark analytical support

Biology highlights

  • >11000 sq. ft. of lab space; Custom assay development
  • Throughput screening & SAR support, Cell line generation, Cell assays & High content screening, Protein production, Biochemical assays, SPR, Electrophysiology
  • Target engagement/PK-PD studies Biomarker assessments, Efficacy models

DMPK highlights

  • 18000 sq. ft. of lab space
  • Fully integrated automated Wave-1 ADME, IDOT, API7500, HRMS, large cell culture suites, validated drug transporter assays, IND packages
  • Organoid technology AAALAC accredited Vivarium, OLAW certified labs, state of art histopathology

Developability & Formulations highlights

  • Pre-formulation packages-customised or extensive, including physicochemical profiling, solubility profiling, dissolution, solid-state, crystallinity assessment, hygroscopicity and bulk behaviour.
  • Particle size reduction (micronisation) capability- to be added in next 3-6 months.
  • Amorphous screening (spray drying)- to be added in next 3-6 months.
  • Stability evaluation of compounds and preclinical formulations

 

 

CMC facilities

Process R&D and Analytical Development highlights

Process R&D highlights

  • 120 fume cupboards, parallel experimentation, jacketed lab reactors, fully equipped Analytical R&D Labs, Process Engineering & Pilot Scale Facility, 1µg/m3 containment
  • Technologies – Bio Catalysis, Chemo Catalysis, Flow chemistry, Particle Formation, Nucleosides & Phosphoramidites
  • HPAPI Labs, Process Safety lab
  • Dedicated team for early phase chemistry – pre-clinical
    to First-in-Human GMP supplies

 

Analytical Development highlights

  • Method development & validation
  • Solid state characterization
  • Structure confirmation
  • GTI determination
  • Other specialized techniques
  • Isolation & purification

Early phase scale up highlights

  • 10 reactors of sizes ranging from 100L to 350L
    • MoC
      • Stainless steel
      • Glass-lined
      • Hastelloy
  • 80L and 140L Hastelloy ANFD
  • -100 to +180C range
  • 1ug/m3 containment
  • PLC controls and automation

Process technology highlights

  • Bio Catalysis
  • Chemo Catalysis
  • Flow Chemistry
  • Particle Engineering
  • ATFE & Short Path distillation
  • Liquid-Liquid Extraction
  • Lyophilisation
  • HPAPI
  • Nucleosides & Phosphoramidites