Q-Vant gains GMP certification for QS-21 production in Chile
Q-Vant Biosciences, a biotechnology company headquartered in Chile, has received EXCiPACT certification for Good Manufacturing Practice (GMP) for pharmaceutical excipients at its production facility in Santiago.
The certification covers commercial-scale production of QS-21 and other high-purity saponin fractions used as adjuvants in human and veterinary vaccines. SGS conducted the audit and issued the certification.
Q-Vant said the certification applies to its manufacturing operations and quality systems for production of the vaccine adjuvant materials. The Santiago facility manages processing from Quillaja biomass through purification and commercial manufacturing.
The company said the facility has capacity to produce saponin adjuvants at a scale sufficient to support vaccine programs requiring supplies for billions of doses annually. Q-Vant also produces saponin fractions for oral and mucosal vaccine applications and veterinary vaccines.
EXCiPACT certification provides a GMP framework for the manufacture, testing, and distribution of pharmaceutical excipients and is intended to support quality and consistency in excipient supply.
