Amniotics AB Receives Certificate of GMP Compliance & Manufacturing Authorization Approval

Amniotics AB is the first Swedish cell therapy company to receive approval for production of an investigative ATMP in its own GMP facilities.

The stem cell company Amniotics AB is taking big steps closer in treating lung diseases including COVID-19. The company has now received the Swedish Medical Products Agency’s GMP certification and permission to manufacture trial drugs. Together with the approval as a tissue establishment that was communicated in October, this means that clinical studies with stem cell therapy can now be initiated.

Sweden is among the top three countries in Europe developing advanced therapy drugs (ATMP) based on the number of companies. Nineteen companies in Sweden are developing ATMP of which most of the projects are in pre-clinical stage and a few have reached an early clinical phase. Despite this, no commercial cell manufacturing sites have been approved in Sweden until now.

On November 9th, the Swedish Medical Products Agency announced that, after inspecting Amniotics’ quality system and production facility, it had been assessed that Amniotics complied with GMP (Good Manufacturing Practice) in accordance with current regulations. At the same time, Amniotics received the Swedish Medical Products Agency’s permission to manufacture investigative medicinal products against COVID-19.

In addition, the Swedish Medical Products Agency has previously announced that it approves Amniotics as a tissue establishment. This means that the company has a license to handle human tissues and cells intended for the manufacture of advanced therapy drugs (ATMP).

Taken together, these conditions give green light for clinical trials and the development of specific stem cells for several different treatments. Primarily, Amniotics will select and grow stem cells with lung-specific properties for the treatment of COVID-19 patients. A patent application has been filed for the manufacture of these stem cells.

“Our studies so far, show that the lung-specific stem cells significantly reduce inflammation and fibrosis. The treatment has the potential to both save lives and reduce the acute life-threatening illness time for those who have COVID-19 “, says Amniotics CEO Kåre Engkilde. He continues:

“The Medical Products Agency ‘s approval enables us to expand our program in a series of clinical trials on respiratory indications. The goal is to deliver treatments to patients suffering from severe COVID-19.”

Amniotics AB is a biopharmaceutical company in Christer Fåhraeus’ corporate sphere Fårö Capital, focusing on developing cell therapies for patients in need. The company was founded in 2015 by Marcus Larsson, Niels-Bjarne Woods and Andreas Herbst after the discovery that amniotic fluid from full-term pregnancy can be a source of mesenchymal stem cells (MSC). The stem cells are isolated from amniotic fluid during planned caesarean sections. Drugs of this type fall under the regulations for advanced therapy drugs (ATMP).

Lund November 20th, 2020

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20 November, 2020
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