, told investors on Wednesday that it completed process validation for Pharmaceutical Good Manufacturing Practices (GMP) for LPLDL® as a drug substance and have been given the thumbs up from the FDA.
The certification triggers a milestone payment as per a pharmaceutical deal OptiBiotix has with an anonymous US pharmaceutical, entitling it to a six figure sum.
It is a significant step for the company in the development of LPLDL® as a pharmaceutical drug product. Lactobacillus plantarum LPLDL® is a next-generation probiotic that aids elements of cardiovascular and wellbeing.
It proves that LPLDL® is produced consistently with pharmaceutical grade quality and is required by customers and health authorities around the globe to commercialise active ingredients as drugs.
Shares in Optibiotix were trading 6% higher at 46.5p on Wednesday
Steve Prescott, Chief Executive Officer of ProBiotix, commented: "Completing Pharmaceutical GMP process validation and receiving the GRAS notification letter from the US FDA is a significant achievement for ProBiotix and LPLDL®.”
“Few marketed probiotics have achieved this level of proven safety and efficacy”
Mr. Prescott added “GMP manufacturing is required to commercialise a probiotic as a drug and is a de facto requirement of many companies to include ingredients in their food supplement formulations.”
“Both GMP manufacturing and full GRAS status increases LPLDL®'s market attractiveness and shows ProBiotix's commitment to commercialising the highest quality products.”
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