Our Facilities - Profacgen

Home Favorite

Our Facilities

Our state-of-the-art certificated facility is designed for multi-product operation and delivers a comprehensive range of services necessary to take novel biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch and commercial supply. From the very beginning to our shared target, our first class facility and professional capacity assure us of a smooth pipeline.

Facility and cGMP capacities:


		Qualified class 10,000 and 100,000 cleanrooms with class 100 biohoods.
		Dedicated upstream and downstream cleanroom suites.
		Independent QC and analytical testing laboratories.
		Reliable cell banking services.
		Experienced scientists working according to current Good Manufacturing Practices (cGMP).
		Custom designed to be compliant with FDA cGMP guidelines.
		Production and purification of proteins expressed in mammalian and microbial systems.

Process development:


		Independent pilot production suites to imitate manufacturing operation and process flow for process development.
		Similar equipment and control platform between pilot expression and cGMP manufacturing areas to ensure rapid and successful technology transfer.
		GE pilot purification systems.
		Ultra filtration units.
		Homogenizer, centrifugation and ultra centrifugation.
		State-of-the-art CFR compliant analytical equipment.
		Wide range of product-specific bioassays.

cGMP manufacturing:


		Up to 300L fermentation with capacity for a second 300L vessel.
		A range of disposal production systems or bioreactors for support of clinical development and market supply.
		GE bioprocess and purification systems.
		Homogenizer and centrifugation.
		Centrifugations.
		Ultra filtration units.
		Extensive capacity options for expansion.

Cell Banking Services:


		Independent and dedicated suites for establishing cGMP cell bank.
		Cells grown, maintained and stored within validated incubators and freezers (liquid nitrogen).
		24-hour security monitoring and comprehensive environmental monitoring.
		Single-pass, positive-pressure, HEPA-filtered air unidirectional flow of personnel and materials with appropriate air locks.

Facility and cGMP capacities

Process development

cGMP manufacturing workshop

Cell Banking Services

	1-631-559-9269
	1-631-938-8127(fax)

Info@Profacgen.com