Paragon’s facilities include a state-of-the-art research and process development laboratory as well as fully-validated GMP suites. The process development laboratories include a fermentation pilot plant, pilot scale cell culture capabilities, several purification centers, an analytical laboratory and product storage space. The facility also houses raw material storage, Quality Control laboratories, and administrative offices.
Paragon is located in a secure building with 24-hour security monitoring of the entrance. An electronic card access security system prohibits unwanted entry into the Paragon facility. Vendors and other visitors can only gain access with a Paragon employee as an escort. There is specific card access into preclinical laboratory areas that limits access to those personnel qualified to work within the area.
A Siemens APOGEE Automation System monitors and controls all HVAC functions to the operating space at Paragon (GMP and non-GMP laboratories) to maintain specifications for temperature and humidity. This system also monitors plant steam generation (100 hp boiler), a 60 ton chiller, and CA generation (ATLAS COPCO, oil free).
A remote monitoring/alarm system using cellular technology monitors all CTUs and various points on the utility systems (chiller, AHU, etc) with automated notification via cell phone and text (to Paragon personnel) when an alarm condition is detected. The monitoring system utilizes back up servers and redundant cellular technology to ensure uninterrupted service (Google’s hub for all its east coast servers are housed in the same facility as Paragon’s system).
Our upstream and downstream developmental teams have decades of experience in cell biology, protein chemistry, and bioprocess development. Analytical tools are regularly updated and new ones are added as needed with a practiced flexibility and eye for rigorous data.
- Analytical Instrumentation
- Real Time PCR
- Infrared & Chemiluminescent Detection (Odyssey LI-COR) for Western Blot analysis
- Fluorescent Microscopy
- Electron Microscopy
(FEI Tecnai 10)
- Flow Cytometry
- Gel Electrophoresis
- Capillary Electrophoresis
- Gas Chromatograph
- Analytical Ultracentrifugation
- Process Equipment
- Biosafety Cabinets
(ultra, super speed & benchtop)
- 25 & 100L Wave Bioreactors
- 2, 10, 30, 50 & 200L Stir-tank Bioreactors
- Purification & Filtration Systems
(GE, Millipore, Pall, Sartorius)
- Controlled Temperature Storage w/ monitoring and alarm services: 2-8°C Cold Room, -80°C Freezers, Liquid Nitrogen Tanks
- Separate washroom: autoclave, depyrogenation oven, glassware washer, DI water purification system.
Paragon’s GMP suites were designed to specifically meet manufacturing needs for Phase I/II/III clinical trials of biopharmaceuticals and are run by a highly experienced GMP team.
- Separate microbial, mammalian suites & cell banking suites with single-pass air
- Uni-directional corridor w/ ISO 7 & 8 cleanrooms
- GMP validated production equipment (incubators, fermenters, bioreactors) with capacity up to 240L fermentation and 500L mammalian
- QC environmental monitoring
- Monolithic Flooring
- Clean Steam Generator
- GMP autoclave
- Fill & Finish Capabilities
- GMP materials warehouse with shipping/receipt facilities