Service
For cell and gene therapies the process is the product. Our experienced scientists and engineers will help you assess the varying nature of your process and achieve desired scale, consistency, optimization and GMP readiness.
How can we help?
Leverage our team’s expertise to help you develop a scalable and robust GMP ready process.
Utilize our proven approach for onboarding to accelerate timelines and reduce risks.
Develop and document a process that is repeatable, reproducible and ready for GMP manufacturing.
Consider the importance of product safety, efficacy and quality at each phase of development.
Access scientists with deep expertise in your cell type, vector, product and/or modality.
Our experienced process development team will create a robust GMP-ready protocol that satisfies regulatory needs and minimizes cost.
Our process development team has worked with many of our clients to help them move from bench to scale. These clients have gone on to clear their INDs and manufacturing successfully for clinical trials. We have accompanied multiple clients from process development to commercialization.
Our process development team has worked with many of our clients to help them move from bench to scale. These clients have gone on to clear their INDs and manufacturing successfully for clinical trials. We have accompanied multiple clients from process development to commercialization.
A pool of experienced engineers and scientists with expertise in virology, chemical engineering, molecular biology, manufacturing, analytical method development, and biotechnology will augment your team to help you achieve your target scale and improve GMP readiness.
Our process development team can work with viral vectors (LVV, AVV, ADV, HSV). and cell systems such as CAR-T, TIL, MIL, NK, MSC and others.
Our experience with adherent culture, adherent to suspension conversions, scale up, and downstream purification protocols will ensure the most efficient and robust process is developed.
WuXi Advanced Therapies’ process development team has significant expertise and experience in cell and gene therapy across all phases of development and manufacturing. This gives us the ability to help you develop a product-specific process that maximizes efficiency, minimizes costs, is GMP ready, and meets typical regulatory requirements.
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We collaborate with you to develop or optimize your process to ensure that it is robust, phase-appropriate, scalable, and proven.
SME to SME discussion and understanding
Raw material sourcing
Process-specific equipment needs
Analytical method development or transfer
Smaller scale GMP-like runs
Collaborative problem solving
Process optimization
Final process proofing
In process and release testing documented
Compendial testing
Custom assays
Materials characterization
Viral clearance
Cell line characterization