A plethora of different technical, economical and regulatory aspects, prerequisites and requirements have to be taken into consideration in recombinant protein production process development.
Taking all these aspects into account means using an integrated approach, in which all steps are analysed for their sustainability in later stages of process development, scale-up or commercialization.
Fraunhofer IME's department for integrated production platforms looks back on almost 15 years in the production of recombinant proteins from most of the commercially used expression strains in the 1-350 L scale, using buffer volumes up to 2000L in DSP. We have gained hands-on experience in the production of recombinant proteins used in different markets, such as technical enzymes, research tools, diagnostics or biopharmaceuticals and have worked with different protein classes such as cytokines or full-size mAbs. The department Integrated Production Platform holds a GMP certificate for the production of active pharmaceutical ingredients for clinical trials.
We offer contract research & development cooperations in process development and production of recombinant proteins.