Unique capabilities and expertise make Paragon Gene Therapy the manufacturer of choice for biotech and big pharma customers seeking a high-performance provider of biologic services.
We are capable of taking a client from development of an expression vector to performing process development (both upstream and downstream) and into cGMP manufacturing of biologics specifically for clinical trials.
Our facilities are designed specifically for the production of proteins, monoclonal antibodies, recombinant vaccines, and virus-like particles under cGMP regulations. We maintain segregated suites and use single-use technology for microbial and mammalian/insect cell manufacturing, each with an ISO class 8 manufacturing & ISO Class 7 purification room. We perform technology transfers via our internal process development group, who ensure consistency throughout the entire manufacturing process.
- Gene Therapy
- Adeno Associated Virus (AAV)
- Adenovirus, Retrovirus
- Viral vectors
- Mammalian: Virus Like Particle (VLP)
- Wild type viruses
- Microbial proteins, conjugates
- Other Biologics
- Therapeutic proteins, monoclonal antibodies
- Microbiome, live bacterial
- Process Development Capabilities:
- Cell line construction
- Upstream process
- Downstream process
- Analytical development
- cGMP Manufacturing Capabilities
- Both non-GMP and cGMP Phase I/II
- Segregated facilities for Mammalian/Insect, Microbial & Virus
- Cell and Virus Banks (Master & Working)
- Drug Substance & Drug Product Manufacturing