Quality Control (QC) is at the fore-front of ensuring product safety, identity, strength, purity, and quality (SISPQ) by detecting defects prior to product release and ensuring the manufacturing environment is clean and under control. Our QC team, with our Tech Transfer team, is experienced in providing a seamless transfer from customers to our QC labs.  As well as qualification and validation of analytical methods from development to commercial manufacturing.

Our Quality Control testing capabilities include:

• Chemistry – Mass Spectroscopy, HPLC/UHPLC, UV, Sub-visible Particle Analysis, Protein Concentration, etc.
• Biochemistry – ELISA, Cell-Based Assays, qPCR, SDS-PAGE, CE/cIEF, etc.
• Microbiology – Sterility, Bioburden, Endotoxin, etc.
• Raw Materials – Raman, UV, HPLC, Karl-Fischer, primary and secondary packaging tests, moisture, etc.
• Environmental Monitoring – Surface, viable and nonviable air particulates
• Utilities – Water and gas (TOC, Heavy Metals, Microbial limits, etc.)
• Stability Studies – Long-term, Accelerated and stress conditions, photostability, etc.
• and more to fit your needs.

For details:

• CLB Quality Overview
• CLB Quality System
• Quality Systems Model
• Integrated Digital Quality Systems
• Regulatory Affairs
• Quality Engineering – Validation
• Quality Future