Rockville Viral Vector CDMO Facility Overview
With integrated CDMO services, our diverse product offerings provide versatile gene delivery tools supporting in vitro and in vivo experiments. The site specializes in GMP-compliant production of adeno-associated virus (AAV), lentivirus, adenovirus, and retrovirus for gene and gene-modified cell therapies.
Dedicated Viral Vector Manufacturing Facility
- Established Contract Development and Manufacturing Organization (CDMO)
- Vigene Biosciences was founded in 2012 and acquired in 2021 by Charles River
- Research Court CDMO Facility: 50,000+ square feet/4,600+ square meters
- Located in the Baltimore/Washington DC metropolitan area, one of the nation’s largest biotechnology clusters
- Close proximity to Washington DC, National Institutes of Health (NIH)
- Eight production suites including four GMP viral vector suites and a dedicated cell banking suite (adherent and suspension)
- 130 employees
Compliance, Certifications, Accreditations & Affiliations
Our Rockville, MD CDMO facility operates in compliance with the following regulatory agencies or accredited organizations:
- Good Manufacturing Practice (GMP)
- Food and Drug Administration (FDA), USA
- European Medicines Agency (EMA)
Rockville CDMO Facility Service Areas/Study Types
Our viral vector CDMO facility supports developers with the following services:
- Cloning
- Molecular cloning
- Gene synthesis and mutagenesis
- shRNA cloning
- CRISPR/Cas9 cloning
- Mammalian cell banking
- Virus banking
- Viral vector process development and manufacturing
- Research-grade viral packaging services for in vitro and in vivo studies
- GMP viral vector manufacturing
- Analytical testing
- Stability studies
- Fill finish
Viral Vector Testing Services
Our team supports developers with the following testing services, which vary by product/client:
- Identity
- SDS-PAGE
- Western blot
- DNA sequencing
- Strength/potency
- Viral titer
- Infectious titer
- Bioassay
- Empty/full ratio (AAV-specific)
- Impurities
- Residual host cell protein
- Residual host cell DNA
- Residual benzonase
- Adventitious viruses
Viral Vector Research Products
Our viral vector CDMO facility also supplies off-the-shelf and ready-to-ship research grade products:
- AAV Products
- LVV Products
CGT Manufacturing Scale Up Resources
Manufacturing challenges are common, yet the industry is committed to making life-changing cell and gene therapies accessible to patients. We've gathered key resources from our experts on important considerations, innovative technologies, and tips for meeting regulatory requirements in your CGT scaling strategy.
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