GMP certified Reniale® production at EMCM

September 9, 2014

The Dutch Healthcare Inspectorate (IGZ) and Farmatec/CIBG granted EMCM the respective GMP certification

EMCM is happy to announce that, on July 14 and August 13, the Dutch Healthcare Inspectorate (IGZ) and Farmatec/CIBG granted EMCM the respective GMP certification and manufacturing authorisation for the production of the personalised medicine Reniale®.

With this successful audit, EMCM has shown to be able to aseptically manufacture human extracted products into small volume liquids under full GMP conditions.

This authorisation is part of a milestone program together with VCC Medical N.V., a full daughter of Vaccentis AG in Zurich, Switzerland.

About Reniale®
The personalised medicine Reniale® is manufactured especially for the affected patients using the patients' own tissue and offers an extensive distinguishing characteristic to the immune system, on which basis remaining tumour cells can be eliminated. It can prevent the development of new metastases after the removal of the kidney or parts of the kidney. Reniale® is currently the only medicine of its sort in the world with such comprehensive documented experience (studies over 5 and 10 years).

About EMCM
EMCM develops and manufactures sterile medicinal products in GMP and ISO accredited facilities, conforming to the standards of the USFDA, EMEA and ISO for the biomaterials, pharmaceuticals and tissue engineering markets. EMCM produces a broad range of medical products, offering complete custom-made service and product packages (product development, regulatory affairs, purchasing, manufacturing, final packaging, warehousing and distribution in the capacity of a contract manufacturer). EMCM also produces and sells human and animal tissues for the orthopaedic, trauma, dermatological and regenerative markets. EMCM manufactures human grafts and xenografts under the flagship eTiss® and eColl® product portfolios, respectively. Controlled drug delivery and peptide delivery mechanisms embedded in the aforementioned carriers are under development.

For more information about EMCM, please contact us.

About Vaccentis
Vaccentis as a comprehensive business organisation is the manifestation of the constant strive to unite what belongs together. In detail this means: consolidation of experienced experts and successful products based on a common therapy approach, as the personalised or individual treatment methods illustrates. Commercial and technical concerns can only benefit from such a synergy. The field of complementary and natural medicine is represented by the Vaccentis subsidiary FBM-PHARMA in Ludwigshafen/Germany. The core area here is the researching and manufacturing of individual medicines such as AHIT® for the permanent correction of disorders in the immune system. Persons with atopic or autoimmune diseases such as neurodermatitis, allergies, psoriasis, asthma or rheumatism are primarily addressed here.

VCC Medical N.V. in Maastricht / Netherlands continues the promising work with the Reniale® medication in the field of evidence-based medicine. This individual therapy has shown benefit in the post-operative follow-up therapy of patients with renal cell carcinoma. The aim of the consolidation is to consistently further develop well-established medicines in the field of autologous patient treatment which is common to both business units. We want to contribute to increased chances of cure in the field of chronic and malignant disorders.

For more information about Vaccentis, please visit www.vaccentis.com

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