21 January 2015—Eufets GmbH is happy to announce it is advancing a program to automate and further scale-up its technology for the production of retroviral vectors.
As a leading service provider in the field of cell and gene therapy manufacturing, Eufets has established a program that will allow the company to automate its viral vector production. The current program is performed with the use of Terumo BCT’s Quantum® Cell Expansion System.
The Quantum system is a closed, automated, single use bioreactor that has been successfully used for clinical grade manufacture of cells and viral vectors for use in regenerative, gene, and immune therapies. For detailed information please see www.terumobct.com/quantum.
Through the use of the Quantum system, Eufets has been able to establish a production process that allows improved control of the process, reduces risk of infection, significantly reduces operator handlings and allows production of high volume/ high titer viral vector batches.
Jens-Oliver Michel, Scientist Process Development at Eufets states: “We are very pleased with the results so far. Using the Quantum system allows us to achieve better control and higher batch to batch consistency in our virus production with less involvement of operators.”
In the coming months, Eufets aims to prepare the process for GMP production. Dr. Klaus Kühlcke, Managing Director of Eufets and known expert in the field of viral vector production says: “We need to do some more process characterisation, but feel that by mid 2015 we will be able to offer the new process to our clients to support their current clinical trials and their future commercialisation. With the success of the adoptive T-cell therapy the request for our services has increased. We feel that with this program, we are able to serve all our clients to their needs”.
About Eufets GmbH:
EUFETS is a specialist in CMC services for the pre-clinical and clinical development of viral vectors and cell based medicinal products. Currently owned bio BioNTech, EUFETS was founded in 1997 and became a subsidiary of Fresenius Biotech GmbH, Germany in 2001.
The company employs more than 70 experienced and highly skilled scientists, technicians and administrative employees.
EUFETS has collaborated with clients from the EU and the US. So far more than 1200 products for cellular therapies have been produced at EUFETS. Clinical candidates manufactured at EUFETS have been investigated in numerous clinical trials in the EU, US and Australia.
The company´s facility complex is located in Germany in the city of Idar-Oberstein, about 1,5 hour apart from Frankfurt International Airport and is more than 4500 m² (48.000 sq ft) in size. EUFETS is operating more than 600 m² (6.500 sq ft) of R&D, QC and GLP laboratories and state of the art GMP facilities of 500 m² (5.400 sq ft).
Laboratories and clean rooms are classified BSL 2 to BSL 3** and allow manipulations of a wide range of biological agents and patient samples. Our multi product GMP facility is segregated from the laboratories and is designed to allow full aseptic processing from cell expansion through filling of drug product in clean rooms classified up to grade A in B.
Tel. +49 67 81 · 98 55 0
Fax:+49 67 81 · 98 55 237
This press release was issued by EUFETS GmbH.