In-house Quality Control Lab

Our quality team is committed to working seamlessly with our clients and can offer exceptional quality and regulatory support on demand

Our Sarasota facility features a 1,500 ft² in-house quality control laboratory with a full suite of analytical development and validation capabilities. We are committed to manufacturing products employing top-of-the-line equipment and systems under a cGMP-compliant quality management system (QMS) to ensure quality and reliability of supply, every time.

In-house quality capabilities:

• Concentration (USP <857>)
• pH (potentiometric)
• Osmolality (USP <785>)
• Conductivity (USP <644>)
• Purity Ratio (A260/A280 by UV spectrophotometry)
• % DNA Supercoiled (Densitometry)
• Appearance (USP <790>)
• Restriction digest (Fragment analysis by restriction enzyme mapping)
• Size (Agrose gel electrophoresis)
• Residual host genomic DNA (qPCR)
• Residual host cell protein (ELISA)
• Residual host genomic DNA (qPCR)
• Residual host RNA (Fluorescence)
• Endotoxin (Kinetic chromogenic LAL)
• Bioburden (USP <61>)
• Sterility (USP <1071> or USP <71>)