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Upstream Process Services
Biologics are produced via a variety of methods and all sorts of microorganisms (bacteria, yeast, fungi and eukaryotic cells), and at Biodextris, we are experts with many of the species used in industry. From the beginning, we aim to identify and control the key process parameters that will provide your product with the optimal set of critical quality attributes.
Biodextris can be your guide navigating through the following activities in establishing an upstream process:
- Media evaluation
- Host strain evaluation
- Cell line development
- Development of batch or fed-batch protocols
- Product optimization strategies (yield increase, reducing undesired product)
- Analytical parameters
We develop your upstream process using industry leading pilot-scale fermenters and bioreactors. Our systems are interfaced for continuous monitoring, control and data acquisition of temperature, pH, agitation, airflow, pressure, dissolved oxygen, exhaust gas (O2/CO2) and nutrient feeds all in a GMP cleanroom environment where applicable.