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 analyzed 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 20 years in the production of recombinant proteins from most of the commercially used expression strains in a 1-350 L scale, using process volumes up to 2000L in DSP. We have long-lasting experience in the production of recombinant proteins used in different markets, such as technical applications, research tools, diagnostics or biopharmaceuticals and have worked with different protein classes such as cytokines, enzymes 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 services in process design, optimization and scale-up as well as for the production of recombinant proteins.