We are seasoned scientists, fueled by curiosity.
Our team offers a wealth of experience with recombinant viral vector development and GMP manufacturing for cell and gene therapy that will help you get your project moving at the speed of science.
Why partner with Paragon Bioservices?
WeÃ¢â‚¬â„¢re passionate about science, just like you. Which means we seek out projects based on our enthusiasm to push science forward. And that approach has driven our team of experienced scientists to help develop hundreds of recombinant viral vectors, including AAV, adenovirus and retrovirus, that have changed the face of medicine.
While other CMOs may focus on one or two specialties, our team offers experience and insight for a wide range of areas. Our depth of experience has allowed us to learn a lot of different approaches to new challenges, which translates to fewer roadblocks and accelerated development. Plus, with our cutting-edge technology, weÃ¢â‚¬â„¢re able to work closely with you to solve problems and ensure that your project is delivered on time.
Recombinant Viral Vector Development and GMP Manufacturing for Cell and Gene Therapy
- Strong process and analytical development capabilities
- Large process development staff to support development projects (more than 70 scientists)
- Unique bioprocess and analytical technologies (DASGIP® Parallel Bioreactors, Pall Micro-24 and iCELLis Nano Bioreactors, CARR® UniFuge®, PKII Ultracentrifuge, electron microscopy, SEC-MALS)
- AAV, adenovirus, retrovirus and other viral vectors
- Cell lines (HEK293, Sf9, CAP®, Vero, HeLa)
- Suspension and adherent, including Icellis HYPERStack®, CellSTACK® and microcarriers
- Transient transfection, virally transduced and baculovirus expression vector system
- Focus on Phase I and II cGMP manufacturing
- More than 50 clinical batches since 2010
- Heavily reliant on single-use technology including 50L, 200L and 500L Bioreactors
- Dedicated BSL-2 facilities for microbial, cell culture/insect and virus manufacturing
- Master and working cell banks and virus seeds
- Bulk drug substance and finished drug product (aseptic liquid fill)
- Separate and dedicated microbial, mammalian and virus facilities with single-pass air
- Unidirectional corridor with ISO 7 and 8 cleanrooms
- GMP-validated production equipment
- Single-use disposables for upstream and downstream processing
- Fully automated small-batch fill/finish suite with completely disposable product path
- Siemens APOGEE® Automation System monitors and controls all HVAC functions, clean steam generator, chiller and clean air generator
- First GMP facilities commissioned in 2010; expanded in 2012