In Spring of 2009, we completed construction of an entirely new facility featuring 21,000 sq ft of space for research, process development and GMP manufacturing of biologics—as well as administrative and executive offices.
Conveniently located in downtown Baltimore, Maryland, the facility features:
- LEED certified at the Silver level for core and shell
- Electronically-controlled access to/within the facility
- Single-pass air throughout all laboratories and GMP suites
- Fully-segregated, ISO-classified manufacturing, purification and cell banking suites
- Dedicated support facilities, such as air handling, USP water and pure steam
GMP Manufacturing
Small-batch GMP manufacturing of biologics suitable for Phase I/II clinical trials or reagents for diagnostics is a logical extension of Paragon’s preclinical research and process development services, and the new facility was expressly designed in accordance with business plans to add that line of business into the company’s service portfolio.
Preclinical Research
Paragon has expanded its capacity to deliver preclinicial research services with the addition of approximately 9,000 sq ft of preclinical and process development lab space at its facility, while maintaining a condensed presence at is legacy location for the contract production of bacteriophages.
The preclinical research areas feature:
- Labs supporting histology, molecular biology, protein production & purification and assay development
- A dedicate microscopy suite with extensive digital imaging capabilities
- A dedicated electron microscopy suite
- A fully segregated preclinical microbial fermentation suite
- A dedicated RO/DI water system
- Automated electronic monitoring and alarming of CTUs
- A dedicated chemical storage & buffer prep room
Process Development
The activities involved during process development lend themselves nicely to being performed in the dual-purpose preclinical research / process development laboratories and work rooms.