cGMP Core Quality Control Laboratories





Daniel Kota, PhD

Director, Office of Translational Production & Quality

Director, cGMP Core


Gerard Baham

Quality Control Chemist, Office of Translational Production & Quality



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.





  • Endotoxin Testing
  • Environmental Monitoring
  • 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

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