- MinervaX ApS has partnered with Wacker Biotech to manufacture the active ingredients of its Group B Streptococcus (GBS) vaccine.
- Wacker Biotech will handle technology transfer, process validation, and commercial manufacturing of the vaccine’s active components at its Amsterdam site.
MinervaX ApS, a Danish biotechnology firm, has entered a collaboration with Wacker Biotech, a contract development and manufacturing organisation (CDMO), to manufacture the active protein ingredients for its Group B Streptococcus (GBS) vaccine.
MinervaX is developing a novel prophylactic vaccine against GBS, a bacterium responsible for severe infections in newborns and vulnerable adults. Currently, there is no fully protective preventative treatment for GBS. The company has completed two Phase II clinical trials of its vaccine, which has shown a positive safety profile and strong immunogenicity. Phase III trials are upcoming, and a Phase I study in older adults is also underway.
Wacker Biotech will be responsible for manufacturing the active ingredients of the GBS vaccine. The company will also handle technology transfer, process validation, and process characterization activities required for later commercial manufacturing. The production will take place at Wacker Biotech’s facility in Amsterdam, The Netherlands.
Per Fischer, CEO of MinervaX, stated, “GBS can be life-threatening for newborn babies and is linked to over half a million preterm births annually. Following the EUR 54 million financing last year, our team is advancing the development of our novel prophylactic vaccine against GBS for the benefit of all populations at risk, worldwide.”
Ronald Eulenberger, Managing Director of Wacker Biotech, added, “With our strong background in E. coli processes, process characterization, and process validation experiences, we at Wacker Biotech are perfectly suited to support MinervaX with its ongoing program for the prevention of invasive GBS disease.”