Contract development and manufacturing organization (CDMO) Wacker Biotech will manufacture active protein ingredients for MinervaX’s Group B Streptococcus (GBS) vaccine. The German-based CDMO has been tapped to help meet the supply for clinical and commercial purposes.
Wacker will act as MinervaX's CDMO for their lead candidate on a fee-for-service. MinervaX will remain solely responsible for clinical development and the regulatory approval process. The financials of this partnership were not disclosed.
“Wacker will perform technology transfer, scale up, GMP manufacturing, and prepare for both market supply (including process characterization and validation) and commercial supply for the active ingredients in the MinervaX GBS vaccine,” a spokesperson for Wacker told BioProcess Insider.
“MinervaX is relying on Wacker for commercial supply. A state-of-the-art fermentation line like the new 350-L line in Amsterdam, [Netherlands] is key to ensure stable market supply. The 350-L scale is selected to match the expected commercial need for the GBS vaccine.”
MinervaX’s lead vaccine candidate GBS-NN/NN2 vaccine is a novel protein-only vaccine based on fusions of highly immunogenic and proactive protein domains from selected surface proteins of GBS. The company has successfully completed two Phase II clinical trials of its maternal vaccine against GBS and is in preparation to commence Phase III clinical trials in this indication.
“Each technology transfer and scale of a GMP-compliant process comes with challenges. Those could be of technical, organizational, or logistical nature. The Wacker team is experienced in anticipating such challenges as well as solving challenges ad hoc,” the spokesperson added.
“Wacker and MinervaX follow the relevant guidelines for process characterization and validation to demonstrate the new drug can be manufactured robustly and safely.”
GBS is responsible for nearly 50% of all life-threatening infections in newborn babies. At any given time, some 15-25 percent of the population, including pregnant people, are spontaneously colonized with GBS. They run the risk of transmitting the bacteria to their child in the womb, during birth, and/or during the first months of life.
You May Also Like
