Frequently asked questions
Which viral vector platforms do you work with?
We support AAV, AV, and other viral vector platforms for gene and cell therapy applications. The development and manufacturing strategy is tailored to the vector, production system, product quality requirements, scale, and overall needs of the program.
Can you work with a viral vector process developed elsewhere?
Yes. We can onboard processes developed by clients or other development and manufacturing organizations. We assess the available process history, analytical methods, manufacturing information, and supporting data to identify gaps and establish a technology transfer plan appropriate to the maturity of the program.
Can you optimize an existing viral vector process before cGMP manufacturing?
Yes. An incoming process does not need to be manufacturing-ready. Where needed, we can optimize upstream and downstream process parameters to improve productivity, product quality, robustness, and scalability before transfer into cGMP manufacturing.
Can you develop both upstream and downstream viral vector processes?
Yes. Our capabilities cover integrated upstream and downstream process development. Development activities can include optimization of production conditions, harvest and clarification, purification, concentration, and other process steps required to establish a robust and scalable manufacturing process.
How do you manage technology transfer into viral vector manufacturing?
Technology transfer is coordinated across process development, analytical, manufacturing, quality, and other relevant functions. We assess the incoming process and available data, identify technical and operational risks, and define the studies or adaptations required for scale-up and cGMP implementation.
What viral vector manufacturing scales can you support?
Our mammalian cGMP manufacturing infrastructure supports viral vector production at working volumes up to 1,000 L, allowing processes to progress from development and scale-up into clinical manufacturing.
Can viral vector manufacturing be integrated with plasmid DNA and other services?
Yes. Viral vector programs can be integrated with complementary capabilities including plasmid DNA development and manufacturing, analytical development, cell banking, and other advanced therapy services. This can help streamline development and manufacturing activities across interconnected parts of a gene therapy program.
Where are your viral vector development and manufacturing capabilities located?
Our viral vector and gene therapy capabilities are based at our Vilnius, Lithuania gene therapy CDMO site.
