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>)

More on pDNA & Endonuclease Manufacturing

Grades
Facility & Quality Systems
cGMP Cleanrooms
Process Development Lab
Quality Control Lab
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