Full line continuous manufacturing solution

Mycenax's Full line continuous manufacturing solution offers a single-use continuous manufacturing solution that allows flexible manufacture of biopharmaceuticals according to market demands. Our next-generation technology platform uses a streamlined manufacturing process that has been optimized for the lifecycle of critical raw materials and manufacturing equipment, production operations and automated control of production equipment.

	Feature	Benefit
Quality improvement	Validated manufacturing equipment and parameters All connections between manufacturing steps fully controlled by programmable logic controls (PLC) Real-time recording of all key parameters and operations at each process step	Great accuracy and consistency of process and product quality Minimization of variability caused by manual operations and human errors Reduction of resources required for manufacturing operations Operators can focus on data analysis, problem-solving, process improvement
Time-saving	Fast process initiation after inoculation of cells into the bioreactor The rapid output of the product to fill and finish line	Reduction of production time up to 40%
Cost	Manufacture by small-scale bioreactors instead of large-scale production Single-use small-scale purification columns Continuous disposable process materials instead of stepwise manufacturing process materials	Reduction of overall floor area required for production Reduction of investment in manufacturing equipment Reduction of investments in purification resin to less than 5% compared to the stepwise manufacturing process

Technology Platform

Perfusion fermentation as continuous fed-batch culture
Purification process using single-use chromatography technology (e.g. affinity column, ion-exchange chromatography)
Perfusion by hollow fiber or TFF
Optimization of individual purification steps depending on the results of continuous processing and synchronization with an upstream perfusion rate
Upstream and downstream process scale-up and the technical transfer

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