GMP Manufacturing for Cell and Gene Therapies
Comprehensive capabilities and support built for every stage of your program.
From Process to Product – Delivered with Precision
Whether clinical or commercial scale, bringing a viral vector-based therapy to patients requires more than just capacity, it requires a partner who understands the complexity of viral vector production at every step.
With over 50 INDs supported and more than 7 pre-commercial programs, our viral vector experts have the experience to de-risk your production and keep your cell & gene therapy programs moving forward with scalable operations designed for reproducibility, yield, and purity.
Viral Vector Production
- AAV, lentivirus, adenovirus, and other vector manufacturing scaled to your program’s stage and volume needs
- Track record producing viral vectors from early clinical batches though larger scales, with processes designed to scale predictably
- Experience supporting programs across a range of therapeutic areas, with unique manufacturing considerations
Scale & Capacity
- Multiple dedicated viral vector cGMP production suites for suspension manufacturing from 50 L to 2,000 L
- Flexible processing with single-use technology, closed systems, and perfusion capabilities
- Isolator-based fill line supporting a range of volumes and vial formats for end-to-end supply
Comprehensive QC & Analytics
- On-site support from early characterization through GMP-compliant in-process, release and stability testing
- Comprehensive assay panels tailored to viral vectors for identity, purity, and potency
- qPCR, ddPCR and other methods to accurately quantify vector genomes and infectious titers
- Impurity and residual testing to meet purity specifications
- Compendial testing in accordance with USP, Ph. Eur., and other pharmacopeial standards
Regulatory Support
Throughout your molecule’s lifecycle, we leverage our global regulatory agency interaction experience to provide dedicated and customized support for regulatory IND/IMPD & BLA/MAA filings, inspections, and responses.
Get in touch with our viral vector experts.
FAQ: Viral Vector Manufacturing
We support a broad range of viral vectors, including AAV, lentivirus, adenovirus and other viral vectors for gene modified cell therapies, gene therapies, oncolytic therapies, and vaccines from pre-IND through commercial scale production.
Onboarding times vary based on program complexity and stage. Our program managers lead a cross-functional program delivery team and are equipped with best-in-class project management tools to maintain your project scope and deliver to agreed milestones within the contracted budget.
We offer flexible scalable capacity designed to support everything from small clinical batches to larger commercial supply runs. Our multiple dedicated production suites for suspension manufacturing range from 50 L to 2,000 L volumes.
After initial discussions about your program and needs, our team conducts an assessment to understand scope, timeline and complexity. From there, we provide a detailed proposal outlining pricing, deliverables, and estimate project timeline, so you have full clarity before beginning a partnership with us.
