Viral Vector
Bringing Excellence in Manufacturing & Quality to the Rapidly Growing Cell and Gene Therapy Market
Invested $75 Million into the future of Cell & Gene Therapy
We've expanded our CDMO service offering into the rapidly growing cell and gene therapy market.
The company constructed a world-class, purpose-built 53,000 sq. ft. viral vector development and CGMP manufacturing facility in Costa Mesa, CA.
Purpose-Built Viral Vector Facility
World-Class Viral Vector Development and Manufacturing Facility in Orange County, CA
- Located in Costa Mesa, California approximately 5 miles from our existing campus
- State of the Art Process Development and Quality Control Laboratory Space
- World Class CGMP Manufacturing Space for Viral Vectors
MEET OUR HEAD OF TECHNOLOGY
Elie Hanania, Ph.D.
- 30+ years of experience in the cell & gene therapy field
- 15+ years of experience in the CDMO sector
- Subject matter expert in process development for viral vector production, purification, & characterization
- Extensive experience with a wide selection of viral vector products
Process Development
- Experience with Various Vector Types
- AAV
- Lentiviral Vector (LVV)
- Oncolytic Viruses
- HSV
- Adenovirus
- Exosomes
- Others
- Offering a Wide Range of Viral Vector Characterization Assays
- Develop and/or Tech Transfer:
- Assays
- Platform
- Client-Specific
- Viral Vector Production
- Viral Vector Purification
- Generation of Bulk Drug Substance
- Assays
- Optimize and Transfer Processes to CGMP Manufacturing
- Optimize and Transfer Analytical Assays to Quality Control
- Site-Wide Support for Client-Related Viral Vector Programs
CGMP Viral Vector Manufacturing
- CGMP Cell & Viral Banking
- Bioreactor Capacity
- Train A:
- 500L Single-Use HyPerforma DynaDrive Bioreactor Capacity
- Capable of adding up to a 3,000L Single-Use Bioreactor or Adherent Fixed-Bed Bioreactors
- Train B:
- Master & Working Cell Banking
- Suspension Culture
- Capable 50L & 500L Single-Use HyPerforma DynaDrive Bioreactor Capacity
- Adherent Culture
- Capable of up to 40 CS10s or 20 HS36s Batch Sizes
- Train A:
- Semi-Automated Fill & Finish Capabilities
- SKAN PSI-M Isolator
- Up to 2,000 Vials Per Session
- QA Product Release Testing
