Virus Production

In addition to its current GMP facility, Paragon has recently constructed a totally segregated new facility dedicated to virus manufacturing and research services. The 8000 square feet facility is completely separate with respect to utilities, equipment, and personnel. This facility includes a state-of-the-art process development laboratory and a newly constructed GMP suite. The process development laboratories include two fermentation suites, several purification centers, an analytical laboratory and product storage space. The facility is also equipped with cleanroom suites dedicated to virus production (one microbial suite (40L capacity ) and two mammalian virus suites (cell expansion and production to 25L capacity), and one central downstream suite (for suspension cultures, roller bottles and cell factories):

Adherent cultures

Cell stacks
Roller bottles
Microcarriers

Suspension cultures

Up to 200L, disposable technology

Ultracentrifugation, filtration, and chromatographic-based processing
Brand new state-of-the-art facility
Negative air pressure and single pass air in all suites

BSL-2 Virus Production Facility

8,000 sq. ft. Facility

Research Labs

Process Development

GMP Suites

200L Mammalian Expression

BSL-1 & BSL-2 Manufacturing

ISO-7 Upstream & Downstream Manufacturing Suites

BSL-2/3 Virus Production Facility

2,000 sq. ft. facility

400 sq. ft. Process Development

850 sq. ft. GMP Space

AES modular Architecture & Polyurethane flake floor

Utilities includes:

Safe-change HEPA single-pass air (ISO 7)

Sealed clean-room electrical

Gas manifolds

Decontamination and a magnetic door interlock system(BSL-3 air lock, BSL-3 gown airlock, BSL-3 degown airlock,Exit airlock, and Corridor airlock)

BSL-2/3 facility electrical systems are linked to a back-up generator
Critical equipment such as refrigerators, freezers and incubators are linked to aSiemens control system for 24/7/365 monitoring
Equipment includes

Incubators

Refrigerators

WAVE & Stirred-tank bioreactors

Chromatography & TFF skids

Upstream and Downstream are separated by changeover protocols.

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