COMPANY

BioNTech IMFS - Pioneers in Cell and Gene Therapy Manufacturing

BioNTech IMFS is a Contract Development and Manufacturing Organisation specialised in the industrialisation of cell and gene therapy products such as viral vectors, cellular products and in vitro transcribed mRNA, located in Germany.

Based on extensive expertise in molecular biology, virology and cell biology as well as an understanding of the regulatory prerequisites, our GMP experts support you to develop and manufacture your products in a safe and cost-efficient way. We offer a complete service spectrum from process development through clinical trial medication to in-market supply in our state-of-the-art facility. BioNTech IMFS so far has produced >1000 products for cellular therapies supporting numerous clinical trials for gene therapy worldwide.

  • 20 years in the field of Cell and Gene Therapy
  • GMP certified since 1999
  • Located in Germany in the center of Europe

A Brief History in Facts & Numbers

  • 2017

    1997-2017

     

    This year marks BioNTech IMFS’ 20th anniversary!

  • 2016

    • New contracts for the development and manufacturing of TCR gene therapies
    • Agreement with Medigene for process development and clinical supply of TCR-modified T cells for cancer immunotherapy
    • BioNTech IMFS signs an agreement with Medigene for process development and clinical supply of TCR-modified T cells for cancer immunotherapy
    • BioNTech IMFS becomes partner in the Genentech/BionTech cooperation for the development of individualized mRNA tumor vaccines
    • Vector concentration process established under GMP
  • 2015

    • Clinical supply of several retroviral vectors products for CAR-T-cell tumor immunotherapies (EU and US)
    • Clinical supply of several retroviral vector products for US immunotherapy trials
  • 2014

    • Process development and manufacturing of an allogeneic DC cell therapy product
    • Clinical supply of first patient-specific mRNA vaccine for clinical in vivo application
    • Production of mRNA for clinical ex vivo cell therapy
  • 2013

    • In-licensing of HEK 293-based packaging cell lines (BioVec Pharma) allowing titers >1x10E7 iu/ml
    • Manufacturing license for lentivirally transduced hematopoietic stem cells
  • 2012

    • Clinical supply of mRNA drug product for tumor immunotherapy
  • 2011

    • Manufacturing License for in vitro transcribed mRNA
  • 2009

    • EUFETS becomes a subsidiary of BioNTech AG, Mainz
  • 2006

    • Clinical supply for WAS gene therapy (gene-modified autologous stem cells)
  • 2005

    • New large scale GMP production technique for retroviral vectors
    • Vector concentration process established and validated
  • 2004

    • Manufacturing License extended to gene-modified HIV+ T-cells
    • Clinical supply for phase I/II anti HIV gene therapy (autologous T-cell)
    • Clinical supply for phase I/II CGD (gene-modified autologous stem cells)
  • 2003

    • Accreditation as Good Laboratory Practice (GLP) facility
    • New clean room facility is operational
  • 2002

    • EUFETS supports first clinical trial with gene-modified T-cells
  • 2001

    • EUFETS becomes a subsidiary of Fresenius Biotech GmbH
    • Construction of new clean room facility (9 suites on 2 floors)
    • Manufacturing License for genetically modified T-cells
  • 2000

    • Manufacturing License for retroviral vectors and gene-modified CD34+ stem cells
  • 1999

    • Granted first Manufacturing License for stem cell products
  • 1997

    • Founded as a spin-off from a Bone Marrow Transplantation unit