BioCina will increase the manufacturing scale for recombinant whole-cell vaccine gamma-PNTM 25-fold as part of an expanded partnership with GPN Vaccines.
As per the agreement, contract development and manufacturing organization (CDMO) BioCina will mass produce batches of GPN’s vaccine at its Adelaide, Australia facility, which specializes in microbial cell culture systems such as E. coli.
“The partnership will achieve three main objectives, our process engineers will increase the manufacturing scale 25-fold, to enable large-scale GMP manufacture for Phase II clinical studies, developing and qualifying additional analytical test methods which will be used for in-process control, batch release and stability testing,” Jan Bekker, director of business development, commercial and technical operations for BioCina, told BioProcess Insider.
c/o BioCina
“We will manufacture two large-scale GMP batches for use in GPN Vaccines’ Phase II clinical trial. Its Phase I clinical trial was completed earlier this year (2023),” he added.
The bacterium, which has been estimated to cause up to 2 million deaths worldwide, is responsible for causing life-threatening infections such as pneumonia, bacteremia and meningitis.
“Gamma-PN is a recombinant whole-cell vaccine. The microorganism (Streptococcus pneumoniae) was engineered by the GPN vaccines scientific team to remove all disease-causing genes. The gamma-PN vaccine works by stimulating the human immune system to produce antibodies and long-term immunological protection against S. pneumoniae infection,” said Bekker.
“This already strong partnership will continue to grow over the coming years. We will support GPN through phase III clinical trials, followed by process validation and extensive process characterization, which is required for product commercialization. With the installation and qualification of its new 2,000 L GMP manufacturing capabilities in late 2025, BioCina will also be capable of global commercial supply of this new vaccine,” Mark Womack, CEO for BioCina, told us.
Recently, BioCina partnered with GenomeFrontier Therapeutics to develop virus-free chimeric antigen receptor T cell products (CAR-T) to treat cancer through development and manufacturing of minicircle DNA (mcDNA) and plasmid DNA.
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