FORTSCHRITTSBERICHT JAHR 2006 - Helmholtz-Zentrum für ...

Entwicklungen auf Zentrumsebene
A 1.8.4 Biochemical Engineering (BVT)
Head of Division: Dr. A. Ross (kommissarisch)
The Biochemical Engineering Division – Biotech Facilities – of the HZI act as a technology
service provider for clients within and outside the Helmholtz-Association. These services
comprise the development and scale-up of cultivation processes for microbial and animal
cells, and purification processes for the isolation of biomolecules, such as proteins, nucleic
acids and antibodies from cell mass and supernatant. Various biotechnological pilot plants are
available for this purpose, housing numerous bioreactors, centrifuges, chromatographic and
filtration systems.
The facilities have been licensed since 1997 for the production of GMP-material, in accordance
with the German Drug Act (AMG), thus enabling novel active pharmaceutical ingredients
to be produced for clinical research. In compliance with the regulations, a highly compartmented
clean room pilot plant (GMP I) was installed in 1999. In order to satisfy increasing
demand for capacity and quality, an additional plant was installed in 2001 (GMP II). The
commissioning and qualification of GMP II is currently ongoing.
In May 2004, the Biochemical Engineering Division was successfully inspected by local (Bezirksregierung
Braunschweig) and federal authorities (BfArM – Bundesamt für Arzneimittel
und Medizinprodukte). The HZI is the first German institution to receive a general and nonproduct-specific
GMP manufacturing license.
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