Q-VANT Biosciences and CelluPro have both achieved EXCiPACT GMP certification for manufacturing materials used in biopharmaceutical production, highlighting growing efforts to strengthen quality assurance and global supply chains for critical manufacturing inputs.
Q-VANT’s facility in Santiago, Chile, has been certified for commercial-scale production of QS-21 and other high-purity saponin fractions used as adjuvants in human and veterinary vaccines.
Meanwhile, CelluPro has received EXCiPACT certification for pharmaceutical auxiliary materials (PAMs) at its manufacturing operations in Yantai, China, covering its GMP-grade cell culture media.
Certification targets critical manufacturing inputs
EXCiPACT is an international third-party certification scheme designed to provide independent assurance of GMP, quality management and supply practices for pharmaceutical excipients and pharmaceutical auxiliary materials.
The scheme was developed in part to reduce the burden of repeated supplier audits while providing pharma manufacturers with an independently verified assessment of their suppliers.
The PAM framework is particularly relevant to biopharma manufacturing, covering materials such as cell culture media that are used during the manufacture of medicines rather than being incorporated into the final product.
EXCiPACT also introduced a dedicated GMP approach for PAMs following the development of standards tailored to materials including cell culture media.
For Q-VANT, the certification covers commercial-scale production of QS-21 and other saponin fractions, including its Animune-Q and QS-Oral products. SGS carried out the independent audit.
The company said its vertically integrated operation manages the supply chain from sustainable Quillaja biomass sourcing and processing through purification and manufacturing in Chile.
It claims the facility has capacity to support production equivalent to billions of vaccine doses per year.
Q-VANT said the Santiago certification also provides geographical diversification for the supply of saponin-based vaccine adjuvants.
According to the company’s review of publicly available records, it is currently the only firm in the Southern Hemisphere to have achieved the designation for commercial-scale GMP production of QS-21.
Cell culture media supply
CelluPro’s certification covers its manufacturing of GMP-grade cell culture media, which are used in upstream bioprocessing for applications including recombinant proteins and antibodies, viral vectors and cell and gene therapies.
The Chinese supplier said the EXCiPACT certification builds on its existing cGMP-compliant quality system and other certifications, including ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 22301.
CelluPro has also highlighted its experience supporting biopharma development from process development through to commercial manufacturing.
Its portfolio includes media for CHO and HEK293-based processes, while its manufacturing and OEM capabilities are intended to support scale-up and commercial production.
Why this matters
EXCiPACT certification is becoming an increasingly visible quality credential for suppliers serving the biopharma manufacturing supply chain.
MilliporeSigma, for example, became the first cell culture media manufacturer to receive EXCiPACT certification under the PAM standard in 2024, with certification covering production sites across several countries.
For vaccine and biopharma manufacturers, certifications such as these can provide an additional layer of independently assessed supplier assurance as companies seek to diversify sourcing while maintaining consistent manufacturing quality.
