Mycenax Biotech Inc.

EN

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Drug Product Manufacturing

Mycenax manufactures liquid and lyophilized sterile drug products. Our GMP certified fill and finish facility meets all EU and US requirements. The manufacturing equipment and process have been qualified and validated in compliance with GMP and global regulatory requirements.
 

Pharmaceutical form

Container closure system

Capacity

Batch Size

Liquid

Vial

2R

10,000

4R

10,000

10R

8,000

20R

6,000

Pre-filled syringe

1 mL

10,000

3 mL

8,000

Lyophilized

Vial

2R

3,500

4R

3,500

10R

1,600

20R

1,000













 

Our Capabilities

  • Fill and finish of liquid and lyophilized sterile products
  • Full compliance with GMP including EU, US, and other global regulatory requirements
  • Open restricted access barrier system (RABS) in place providing a physical barrier between workers and production areas to ensure grade A cleanroom environment for aseptic filling
  • Use of single-use filling tubing and needles to minimize the risk of cross-contamination
  • Automatic filling to decrease the risk of human contamination
  • Use of Mycenax’ proprietary technology platforms such as MBIContiTM