Mycenax Biotech Inc.

EN

Please enter the company code as 4726 http://emops.twse.com.tw/server-java/t58query Go to Link

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