Putting Science to Work
biologics-development

Large Molecule Development

Syngene Biologics lab is a state-of-the-art facility with a pilot plant for GMP production of biotherapeutics to be used in clinical studies along with process development and analytical labs.

GMP plant

We have independent suites for microbial and mammalian cell derived products; completely segregated upstream and downstream operations, HVAC and personnel. The facility is designed for optimal personnel and product flow. We have pre- and post-viral removal steps in separate rooms for mammalian DSP. Our production facility includes 225L (Microbial) and 300L (Mammalian) scales and has plans to enhance the output through use of disposable bioreactors. The facility has automated control of process steps, cleaning and CIP through Delta-V system.

Our production area contains the following processing equipments:

Microbial Production Suite Mammalian Cell Culture Production Suite
Seed:
  • Shaker Incubator
Seed:
  • T-flasks, spinner flasks, wave bioreactor
  • Small bioreactors
  • CO2 incubators
Fermenters:
  • 2/5, 30 and 225 L WV fermenters
Bioreactors:
  • Wave bioreactor (1 - 25 L WV)
  • 2/5, 50 and 300L WV bioreactors
  • Also suitable for Perfusion process
Harvest and Cell lysis:
  • Micro fluidizer
  • Continuous centrifuge
  • Batch centrifuge
  • Tangential flow filter
Harvest:
  • Also suitable for Perfusion process
  • Depth filtration (TFF, NFF)
Downstream processing:
  • Up to 500L Refolding vessels & mixing vessels
  • Chromatography skids
  • Tangential flow filtration (UF/DF) skids
  • Sterile bulk fill
Downstream processing:
  • Chromatography skids
  • Tangential flow filtration (UF/DF) skids
  • Viral inactivation and Filtration
  • Sterile bulk fill
Process Development

We have independent upstream and downstream labs for microbial and mammalian based products, and a range of equipment to carry out small scale screening studies as well as process confirmation or tech transfer runs prior to scale up.

Upstream Downstream
  • Spinners/ Shake flasks
  • Bioreactors / Fermenters up to 10L WV
  • Disposable reactors up to 50L WV
  • Wave bags up to 20L WV
  • High speed centrifuge up to 6L capacity
  • Table top centrifuges
  • Bio profile FLEX for cell culture metabolite analysis (Nova)
  • BioProfile 300 for microbial fermentation analysis
  • Micro fluidizer, Sonicator for cell lysis
  • High speed Centrifuge, Up to 6L capacity
  • Depth filters (disposable)
  • ÄKTA Prime, Purifier and Explorer systems
  • Columns up to 50mm ID
  • TFF system up to 0.1 sqm
Formulation Development
  • Spray drier
  • Pilot lyophilizer
  • Vial filling from 0.5mL to 20 ml/ vial
    Analytical & Quality Control
    • HPLC with multiple wavelength (MWD), Photo diode array (PDA), Fluorescence (FD) and refractive index (RI) detectors
    • UPLC with PDA
    • MALDI-TOF/ TOF
    • LC-ESI-MS/MS
    • Biacore
    • Flow cytometer
    • PA 800plus (Capillary Gel Electrophoresis)
    • ICE 280 Analyzer (imaged Capillary Electrophoresis)
    • Slab Gel Electrophoresis ( SDS-PAGE, Blotting, Agarose)
    • Gel Documentation System with calibrated Densitometer
    • ELISA Reader with absorbance, luminescence, fluorescence readers with micro plate well washer
    • Karl Fischer Coulometric Titrator
    • Total Organic Carbon Analyzer
    • Rheometer
    Stability Chambers
    • Stability chambers from -70°C to + 40°C with humidity control
    • Photostability chamber
    • Stability chambers under access control and full GMP operation
    Oligonucleotide Synthesis

    Syngene ventured into the new age therapy services of oligonucleotide synthesis (chemically synthesized DNAs or RNAs) in the Year 2013. The facility houses a wide range of world class equipment for quality services.

    Key instruments are listed below

    Development facility

    • AKTA Oligopilot 100
      • Capacity: 250 µmol to 6 mmol* (1 g to 24 g)
      • Synthesis columns: 6, 12, 24, 48 ml and adjustable column (60 mm diameter)
    • AKTA Pure 150
      • Flow rates: Up to 150 mL/min
      • Purification columns: HiScale 26/20 and HiScale 50/40
    • AKTA Crossflow
      • Flow rates: Up to 600 mL/min
      • Membrane area: Up to 0.4 m2
      • Reservoir capacity: 350 and 500 mL
    • Lyophilizer
      • Capacity: Up to 9L

      *Considering a standard single stranded 21 mer oligo, with yield of ~3g per mmol using PS5G support.

    Pilot scale facility (cGMP)

    • AKTA Oligopilot 400
      • Capacity: 4 mmol to 45 mmol* (12 g to 120 g)
      • Synthesis columns: Fineline 70 and AxiTide 140
    • Semi-automated Cleavage & Deprotection Reactor
      • Capacity: 50 L, MOC: Hastelloy
      • Temperature range: -20 to 150 °C
    • AKTA Process
      • Flow rates: Up to 600 L/h
      • Purification columns: Fine line 100 and 200
      • Accessories: 250L Buffer preparation vessel with WFI water inlet
    • Uniflux 30 (TFF Unit)
      • Flow rates: Up to 60 L/min
      • Membrane area: 0.4 to 4.6 m2
      • Reservoir capacity: 250L, SS 316L Vessel
    • Semi Automated Annealing Reactor
      • Capacity: 60 L, MOC SS 316L
      • Temperature range: -40 to 150 °C
    • Lyophilizer
      • Capacity: 22L (Bulk volume)

    *Considering a standard single stranded 21 mer oligo, with yield of ~3g per mmol using PS5G support

    Analytical facility

    • HPLC - Agilent 1260 series with UV detector
    • HPLC-SEC - Agilent 1260 series with UV detector
    • UPLC - Waters Acquity UPLC with PDA detector
    • LC-HRMS - Thermo Orbitrap ESI coupled to Dionex Ultimate 3000 series UPLC
    • ICP-OES/ICP-MS - Varian
    • Karl Fisher titrator - Metrohm AG
    • UV spectrophotometer - PerkinElmer
    • GC-HS - Agilent 7890/7697A
    • NMR - Bruker
    • Exactive PlusTM EMR HCD
    • Dionex Ultimate 3000 UHPLC
    • Orbitrap (Exactive + EMR): Exactive plus EMR, Exactive plus EMR – 3D model

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