The microbiome-based product will first be launched as a frozen syringe formulation for colonic and enema delivery. Then, it will eventually include oral delivery capsules for improved patient access in the future.
The company hopes to increase its Good Manufacturing Practice — a system that would ensure the product is produced consistently and made at quality standards — so that it can produce more of the needed product, which is in high demand for its novel drug treatment, according to the biotech company. “We are thrilled to achieve market authorization and intend to scale manufacturing of our donor derived microbiome drug product to meet the immediate medical need,” stated Dr. Sam Costello, co-founder and managing director of BiomeBank. It is the first company globally to have regulatory approval for a donor derived microbiome drug product.
The company previously approved its first-generation donor derived microbiome-based therapy product, known as BIOMICTRA. The product is registered in the Australian Register of Therapeutic Goods , a public database of therapeutic goods that can be legally provided throughout Australia.
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