Gene Therapy CDMO
We’re more than CDMO services. Discover our expertise and comprehensive approach to viral vector production.
Years of GMP Experience
GMP Batches Produced
Late-Phase Clinical Programs
INDs
Experience & flexibility to move your program forward
Leveraging our deep technical expertise and broad viral vector knowledge, we deliver flexible solutions to navigate the complexities associated with different viral vector types and their unique production needs.
Adeno-Associated Virus (AAV)
With proven experience across multiple AAV serotypes and cell lines, our tailored processes deliver high-performing gene therapies.
Adenoviral Vector
We have extensive expertise with adenoviral vectors and a range of host cells to support the production of oncolytic viral (OV) therapies.
Lentivirus
Our lentivirus expertise reflects the depth of knowledge and production capabilities across our technical teams to support cell therapies.
Other Viral Vectors
Our expert teams and infrastructure allow us to support the development and manufacturing of diverse viral vectors for various therapies.
Explore Our Viral Vector CDMO Facility
Get a behind the scenes look at our viral vector development and manufacturing facility for cell & gene therapies in College Station, Texas, USA. Watch the video to learn more.
Support from
Pre-IND through Commercialization
Our viral vector CDMO capabilities are focused on delivering scalable, reproducible, and high-performing solutions tailored to your molecule.
Development
Our Process and Analytical Development experts partner with you from early process design through IND-enabling studies to develop robust, scalable process and phase-appropriate testing to support viral vector production.
Tech Transfers
Our development and MSAT teams are built to eliminate tech transfer risk and provide a seamless transition, ensuring your timeline is met and your process performs as expected.
Manufacturing
Our cGMP manufacturing suites are built to translate development-stage processes into consistent, high-quality clinical and commercial supply. With flexible capacity and experienced operations teams, we are dedicated to providing reliable supply and batch-to-batch consistency.
Fill/Finish
Our aseptic fill/finish services are designed and optimized to protect the integrity, sterility, and potency of your viral vector-based therapeutic all the way to the patient.
Analytics & QC
Our in-house analytical and quality control teams provide the scientific backbone behind every development and manufacturing decision, generating the critical data needed at every stage of production from characterization to stability studies.
Regulatory
Our regulatory team works alongside you, providing guidance and customized support for regulatory filings, inspections, and responses, from IND through market supply.
Get in touch with our viral vector experts.
FAQ: Viral Vector Production
We support a broad range of viral vector-based therapies, including gene therapies, oncolytic therapies, and gene modified cell therapies across development, manufacturing, and fill/finish.
The earlier, the better. Engaging during process development allows us to build scalability and regulatory readiness into your program from the start, reducing the risk of costly rework later. We also support drug developers who need to transfer an existing process or scale-up a later stage program. Our teams are equipped to step into any point of the development cycle to support your program.
We build quality into every step of your process. Our facilities operate under cGMP standards with robust global quality systems, in-process controls, and comprehensive documentation practices. Our regulatory team works alongside our development and manufacturing teams from the start of your program to ensure FDA, EMA, and other global regulatory requirements are incorporated.
Yes. Our flexible manufacturing suites and scalable suspension platforms are designed to support your program from clinical batches through commercial supply.
