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cGMP Manufacturing

Culture of Quality

We are founded on a culture that fundamentally believes that quality must be at the forefront of everything we do.

To back up this belief, we are fully committed to the current Good Manufacturing Practices (cGMP). Our quality systems comply with the international standards for Quality Management Systems as defined by the ISO, and are routinely audited by an accredited external body. Our primary manufacturing facility is ISO 9001- and ISO 13485-certified, and our controlled environment clean rooms are graded from ISO 8 up to ISO 5. It is this level of unmatched commitment to quality, along with our strong history of innovation and internal scientific expertise, that defines our culture of excellence.

Standard quality testing is conducted on all batches of custom media. Our standard testing includes: appearance, pH, osmolality, and sterility. Additional QC parameters including cell growth assays and endotoxin testing, may be available upon request.

Quality Highlights

  • ISO-9001 Certification
  • ISO-13485 compliant for CE-marked IVD
  • Fully cGMP compliant
  • EDQM Certification
  • FDA Drug Master Files
  • Sterile fill and finish