Biologics Quality Control

Biologics Quality Control

QC is responsible for raw material quality control, process sample testing, product release assessment, stability studies and environmental control for production facilities.

Capabilities

  • Testing of cell banks, raw materials, and reference materials for GMP manufacturing
  • Monitoring of critical product contact utilities (WFI, PW, Clean Steam, and Compressed Air) for GMP Manufacturing
  • Handling of raw material and product reference samples
  • Analytical method implementation and validation
  • In-process, intermediate, and final product release testing (Bulk Drug Substance, Drug Product)
  • Analysis of samples from process and cleaning validation studies
  • Process characterization studies
  • Environmental monitoring of classified clean rooms
  • ICH-compliant GMP stability program (Intermediates, Bulk Drug Substance, Drug Product, and Placebo)
  • Cell-based bioassays

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INFORMATION