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
	Pre-filled syringe	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 MBIConti^TM

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