cGMP Core Quality Control Laboratories

Our on-site quality control laboratories provide testing and release for manufactured products with strict adherence to FDA requirements. These tests confirm the quality, identity, purity and strength of the manufactured drugs in order to ensure that we deliver a safe and effective product to our patients.

 

Core Director:

Daniel Kota, PhD
Director, Translational Production & Quality
Director, cGMP Core
713.208.0639

Quality Control Chemist:

Gerard Baham
Translational Production & Quality

Services

  • Endotoxin Testing
  • Environmental Monitorin
  • ICH Stability Storage and Testing
  • Inorganic Impurities Testing
  • Method Development and Validation
  • Organic Volatile Impurity Testing
  • QC (batch release) and Raw Materials Testing
  • Temperature Mapping
  • Water Analysis

Quality Control Testing

  • Assay
  • Bacterial Endotoxins
  • Conductivity
  • Constituted Solution
  • Content Uniformity
  • Description
  • Elemental Impurities
  • FTIR
  • Loss on Drying
  • Moisture Content
  • Nucleic Acid Analysis
  • Nucleic Acid Quantitation
  • Particle Size Analysis
  • Particulate Matter
  • pH
  • Purity/Related Substances
  • Real-Time PCR Detection
  • Residual Solvents Determination
  • Residue on Ignition
  • Thermogravimetric Analysis
  • Total Organic Carbon
  • UV-vis
  • Zeta-Potential

Quality Control Equipment

  • Accumet pH Meter
  • Agilent 2100 Bioanlyzer
  • Beckman Coulter Multisizer 4e
  • BioRad CFX Connect
  • Charles River PTS Endotoxin System
  • Denovix Spectrophotometer
  • Fisher Scientific Conductivity Meter
  • Karl Fischer Titrator
  • Malvern Viscotek GPCmax
  • Malvern Zetasizer Nano ZS
  • Mettler Toledo Excellence XS Microbalance
  • Mettler Toledo NewClassic MS Analytical Balance
  • Mettler Toledo Portable TOC
  • Mettler Toledo TGA Star
  • Shimadzu GC2010 Plus
  • Shimadzu ICP-MS 2030
  • Shimadzu IRAffinity
  • Shimadzu Prominence HPLC (ELSD)
  • Shimadzu UV1800
  • Thermo Scientific Muffle Furnace
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