Accelerate biotechnology

Upstream process development

We deliver scalable and robust GMP-compliant production processes for recombinant proteins.

Upstream process development for mammalian platforms

For small scale, high-throughput productions (microgram to milligram range of proteins), we typically apply our SCOUT® technology. This system integrates high-throughput cell culture using mini bioreactors (spin tubes; 2 – 20 mL working volume) with high throughput purification technology (spin-traps and spin-tubes) and matching analytical capabilities. Hereto, we have optimized CHO and HEK293 cell growth in our mini-bioreactors and have developed a number of media and medium feeds. To maximize the information generated during development, while limiting the number of experiments, a Design-of-Experiments (DOE) study format can be supported. For larger scale productions, we deploy a range of bioreactors up to 200 L depending on the development phase of the process. For suspension cultures, typically microwell plates, T-flasks, shake flasks or roller bottles in shake incubators, as well as WAVE Bioreactor™ systems and stirred single-use bioreactors are used, while for adherent cell cultures T-flasks, cell factories in static incubators or stirred tank reactors using microcarriers, iCELLis® systems or scale-X™ bioreactors in R&D and GMP. For these culture formats we can apply batch, fed-batch or perfusion culture protocols, depending project requirements.

All relevant in- and at line analytics are available to monitor and evaluate pivotal upstream process parameters to ensure optimal translation of the culture process to larger scales.

Upstream process development for microbial platforms

For small scale, high-throughput productions as well as for optimization of culture conditions (media, time of induction, inducer concentration, harvest time, etc.), we typically apply our SCOUT® technology. This system allows good aeration and integrates high-throughput cell culture using mini bioreactors (spin tubes; 5 – 10 mL working volume) with high-throughput purification (spin-traps and spin-tubes) and matching analytical capabilities. Hereto, we have optimized E. coli cell growth in our mini-bioreactors and have screened many culture conditions for optimal protein production in shorter periods of time. For intermediate-scale productions and Design-of-Experiments (DOE) studies we use our Multifors in parallel bioreactors (4 x 0.7 L) that allows us to perform process development at small scale but still controlling important parameters as oxygen, feedings, metabolite consumption and pH. For larger scale productions, we use our 10 L Sartorius bioreactors.

Typically, upstream process parameters are monitored by SDS Page or western blot and/or enzymatic assays to monitor protein production. When desired, other analytical or biological assays can also be implemented.

More information?

Downstream process development

Analytical development

Clinical manufacturing

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