Viral vector process development, characterization, and validation
As your viral vector CDMO partner, we have the experience, expertise, and capabilities to guide your program from development, into clinical trials and through commercialization. Our Viral Vector Services (VVS) team has developed more than 60 different viral vectors and supported 10 manufacturing platforms to support brining therapies to market.
What phase is your project: Process Development | Process Characterization | Process Validation
Viral vector process development and optimization
With over 60 products manufactured, we offer extensive experience transferring in, establishing, and optimizing viral vector processes. Development of cell culture processes to support:
- Processes to support suspension and adherent cell culture development including: Suspension: 50L to 2000L single-use bioreactors
- Adherent: Flatstock and iCELLis® platforms
Purification capabilities include:
- Platform purification processes offered for all vector types
- Single-use / non-product contact equipment
- Depth, TFF and other filtration methods for harvest and concentration
- Broad range of chromatography solutions: Affinity, SEC, IEX, and HIC
- Viral inactivation and clearance studies
- Optimization as needed for:
- Increasing yield / recovery
- Full capsid separation
- Specific purity requirements
Available services include:
- Customized transfection and infection parameters as necessary
- Multiple 2L and iCELLis® NANO bioreactors for bioreactor development and optimization
- Multiple 50L and 200L bioreactors for scale up and pre-clinical material production
- ambr® 15 for DoE studies and rapid development
- Custom media optimization, production, sourcing, and testing
- Manifolding for plate-based development
- Partitioning studies
Learn how to develop a robust validation package that supports cell and gene therapies.
DownloadViral vector commercial process characterization and validation
We apply our deep process characterization experience and DoE methodology to define the CPPs and CQAs that enable robust processes, optimal yields, and effective control strategies.
Our approach and available services include:
- Review existing process history and data
- Conduct preliminary risk assessment
- Define/Characterize the unit operations, the KPPs and CPPs, that impact CQAs
- Design and conduct DoE studies
- Generate tabular data and reports to support regulatory filings
- Multiple 2L and iCELLis® NANO bioreactors and ambr® 15 for DoE studies
- Media testing and validation
- Resin reuse studies
- Viral inactivation and clearance validation
