Contract Manufacturers of Sterile Injectables and Non-sterile Products

Support Services

Full Service Lab

Jubilant HollisterStier offers analytical support testing beginning with raw materials through in-process testing to final product testing and release.

Areas of Expertise:

  • Compendia Testing According to USP, NF, EP, JP, and other standards
  • Technical Transfer and Validation of Analytical Methods
  • Microbiology
  • In-Process Testing
  • Biological Assays
  • Finished Product Testing and Release
  • Stability Study Development and Management Including Testing and Storage according to ICH guidelines

Analytical support testing

Microbiological Quality Assurance Department

  • Bioburden Test Validation/Determination
  • Bacterial Endotoxin (Gel Clot Method/Turbidimetric Method)
  • USP Particulate Testing: HIAC/ROYCO and Microscopic
  • Sterility Testing: Direct Inoculation or Membrane Filtration
  • Bacteriostasis/Fungistasis Validation
  • USP Microbial Limits Test
  • USP Antimicrobial Preservative Effectiveness
  • Bacterial and Fungal Identification
  • Container/Closure Integrity Testing by Microbial Immersion

Analytical Chemistry Department

Chromatography

High Performance Liquid Chromatography including:

  • Automatic load/unload of vials
  • Cold shelf loading capabilities down to -45°C
  • Dehumidification system designed by our expert engineers
  • Over 1,200 square feet of combined lyophilizer shelf space
  • Non-destructive lighthouse analysis for monitoring container closure integrity

General Chemistry

  • Karl Fischer Moisture
  • Fourier Transform Infrared Spectroscopy
  • Ultraviolet/Visible Spectroscopy
  • Total Organic Carbon Analysis
  • pH
  • Specific Gravity
  • Osmolality
  • Conductivity
  • Draeger Tube Testing
  • Optical Rotation
  • Compendia USP/EP/JP Testing
  • Viscosity
  • Titrimetry
  • Classical Wet Chemistry
  • ICP - OES

Stability Studies: Storage,
Testing and Program Management

ICH Qualified Storage Conditions:

  • 5° ± 3°C, Ambient Humidity
  • 25° ± 2°C, 60 ± 5% RH
  • 5° ± 3°C, Ambient Humidity
  • 30° ± 2°C, 65 ± 5% RH
  • 40° ± 2°C, 75 ± 5% RH

Ion Chromatography

Gas Chromatography including:

  • Flame Ionization Detection
  • Electron Capture Detection
  • Thermal Conductivity Detection
  • Headspace Analysis
  • Thin Layer Chromatography

Biological Assays

  • Polyacrylamide Gel Electrophoresis (SDS-PAGE)
  • Western Blotting
  • Polyacrylamide Gel Isoelectric Focusing (PAG)
  • Enzyme Linked Immunosorbant Assay (ELISA)
  • Radial Immuno Diffusion (RID)

Protein Determination

  • Lowry
  • BCA
  • Ninhydrin
  • Kjeldhal Protein - Protein Nitrogen Unit
  • Coomassie
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