OptiBiotix Health Share News (OPTI)

(Sharecast News) - Life sciences company OptiBiotix Health announced on Wednesday that its fully-owned subsidiary, ProBiotix Health, has completed process validation under 'Pharmaceutical Good Manufacturing Practices' (GMP) for its 'LPLDL' product as a drug substance.
The AIM-traded firm said it had also received a letter from the United States Food and Drug Administration (FDA) affirming LPLDL's 'Generally Recognized As Safe' (GRAS) status.

It said obtaining GMP certification was linked to a milestone payment under its pharmaceutical deal in the United States.

Completing process validation under pharmaceutical GMP proved that a drug substance, in this case LPLDL, was produced consistently with pharmaceutical grade quality, OptiBiotix explained.

GMP process validation was required by customers and health authorities around the globe to commercialise active ingredients as drugs.

The validation of LPLDL's pharmaceutical GMP manufacture was described as a "significant step" in the development of the product as a pharmaceutical drug product, the board claimed.

GRAS, meanwhile, is an FDA designation that a substance added to food is considered safe, OptiBiotix said.

ProBiotix had obtained a positive opinion from an independent panel of experts earlier in the year, and had now received a letter from the FDA affirming LPLDL's status as GRAS.

That, the board said, was the highest level of safety certification for a food ingredient in the US, and ended an almost three-year scientific and regulatory process.

LPLDL, referred to by its scientific name Lactobacillus plantarum ECGC 13110402, had been assigned the code GRN 000847 in the FDA register.

"Completing pharmaceutical GMP process validation and receiving the GRAS notification letter from the US FDA is a significant achievement for ProBiotix and LPLDL," said ProBiotix chief executive officer Steve Prescott.

"Few marketed probiotics have achieved this level of proven safety and efficacy and it has triggered another milestone payment in the US pharmaceutical agreement we announced last year.

"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."

Prescott said both GMP manufacturing and full GRAS status increased LPLDL's market attractiveness, and showed the company's commitment to commercialising the "highest quality" products.