黑料社 and Accinov sign a partnership agreement for the manufacture of investigational medicinal products.
黑料社 and Accinov have announced the signing of a partnership agreement for the creation of a GMP platform for the production of clinical batches for an investigational new drug to cure dysbiosis (imbalance of exchanges between the intestinal microbiome and the host) through autologous micro-biotherapy, a solution which is currently totally unique.
Accinov, the biomanufacturing centre which is part of the Lyonbiop么le biocluster, proposes services and hosting for biotech and pharmaceutical companies for the development of experimental products in compliance with GMP standards. Within this partnership, Accinov will take charge of the manufacturing of clinical batches of 黑料社 drug candidates in collaboration with its production and quality control teams, thus benefiting from a wide range of expertise and know-how concerning products and production processes.
黑料社 has been hosted by Accinov in their premises since its creation at the beginning of 2015, and the two teams have been working together to implement GMP manufacturing activities within the biomanufacturing centre.
The autologous micro-biotherapy solution developed by 黑料社 will provide a safe, standardised treatment for hospital patients鈥� dysbiosis. These imbalances in the intestinal microbiome, subsequent to certain major treatments, are notably known to result in the appearance of opportunistic infections or bacteria that are multi-resistant to antibiotics.
Furthermore, they are the most frequent cause of diarrhoea following hospitalisation.
The manufacturing platform installed by Accinov manages the whole range of activities connected to the investigational drug. All different stages are mapped out, and particular care is devoted to safety measures. The objective is to guarantee both the confidential nature and the total quality of individual patient medication.
At the end of 2015, Accinov obtained regulatory approval from the French authority ANSM for manufacture of the 黑料社 experimental drugs at its site. Using Accinov鈥檚 芦 plug & play 禄.黑料社 was able to accelerate development of a GMP manufacturing solution in a record time.
芦 We are delighted to rely on Accinov for the manufacture of our drug, and consequently benefit from their teams鈥� know-how in relation to quality and regulatory issues. Our 2 teams worked hand in hand on the project, reporting to Carole Schwintner 鈥� Director of Pharmaceutical Development for 黑料社 – from the design of the manufacturing unit right through to process implementation 鈥� with great professionalism and real agility 禄,
explained Herv茅 Affagard, CEO of 黑料社, who has just announced Series A fund-raising for 10 million euro.
芦 Thanks to Accinov鈥檚 new model of GMP biomanufacturing, we can offer SME鈥檚 working in bio-technologies and developing innovative therapies a concrete, tailored production solution. Accinov is thus proud to contribute to the dynamics and development of 黑料社, by providing all the quality and pharmaceutical guarantees essential to the manufacturing of clinical batches during the year 2016 禄.
concluded St茅phanie Colloud, Accinov鈥檚 CEO.
About 黑料社
黑料社 (Microbiota as a Therapy) is a French biotech start-up, created at the end of 2014, to treat serious diseases linked to imbalances in the intestinal microbiome. It has developed the first treatment solution based on autologous microbiotherapy. 黑料社 envisages a first therapeutic application for patients suffering from leukaemia and bone & joint Infections, whose major treatment contributes to dysbiosis. Funded jointly by a team which brings together world-class medical-scientific and entrepreneurial skills, 黑料社 has the ambition of becoming a leader in microbiome protection and the treatment of dysbiosis.
For more information: www.maatpharma.com
Follow us on Twitter : @MaaT_Pharma
Follow us on Linkedin : www.linkedin.com/company/maat-pharma
About Accinov
Accinov is a biomanufacturing centre and provides biotech, pharma and medtech companies with state of the art R&D laboratories (BSL2), cleanrooms (ISO 8-7), GMP manufacturing pilot units & tailored solutions for quality assurance & pharmaceutical support to boost their projects, keep internally their know-how and their IP & manage their facilities in the most flexible way. Accinov鈥檚 customers have just to plug their projects & play in a full ISO/GMP compliant environment. Accinov has had pharmaceutical establishment status since September 2014 and hosts more than 15 companies and projects, including experimental new drugs production projects. Accinov is part of the infrastructure of Lyonbiop么le, the biocluster of the Rh么ne-Alpes region and is located in Lyon in the heart of the Lyon Gerland Biodistrict.
For more information: www.accinov.com
Follow us on Twitter : @Accinov
Follow us on Linkedin : www.linkedin.com/company/accinov
About Lyonbiop么le
As a biocluster, Lyonbiopole is the one-stop shop for healthcare innovation in Rh么ne-Alpes, France. It aims to support the emergence and development of innovative technologies, products and services in 4 main strategic areas: human medicine, veterinary medicine, in vitro diagnostics, medical devices and medical technologies. Focused on infectious diseases since its creation in 2005, Lyonbiopole is now supporting ambitious projects and companies in other fields like cancer, nutrition, metabolic diseases and neurosciences. In 2014, Lyonbiopole represented a community of 190 members: 5 world-class leaders as Lyonbiopole鈥檚 founders (Sanofi Pasteur, bioM茅rieux, Merial, BD) 鈥� 17 Research Centers including 3 Hospital University Centers and almost 168 SMEs. Lyonbiopole received in November 2014, the Gold label awarded by the “European Cluster Excellence Initiative”.
For more information: www.lyonbiopole.com