Viral Vectors

Process development and analytics

Viral vector process development from concept to patient

With more than 20 years of experience in manufacturing viral gene therapy products across various vector types, our team of scientists have in-depth technical expertise and a comprehensive understanding to design and develop phase-appropriate, commercially viable manufacturing processes.

Our step-by-step process and analytical development approaches are focused on helping you to de-risk your path to the clinic, towards the commercialization of your therapy.

While we run your process, we will perform manufacturability assessment studies in parallel, to enable you to establish a detailed roadmap and efficiently reach your development milestones on time and without sacrificing future requirements for a commercially viable process.

Our subsequent process optimization and development studies are based on defining manufacturing design specifications and critical quality attributes to allow you to establish a robust CMC package to support your regulatory filings.

Upon completion of your process development studies, our process development scientists work in close collaboration with Manufacturing Science and Technologies (MSAT) teams to ensure a successful process delivery into GMP manufacturing, to support both clinical and commercial products.

Our in-house bioanalytical assay development group is highly experienced in developing and optimizing in-process and final product release testing, including cell-based functional and potency assays to meet your needs.

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cGMP manufacturing

Scalability at your fingertips

Our facilities and processes are built with scalability in mind. In a process development setting, we are equipped to support processes up to 250L. For cGMP, we offer suspension-based processes from 50L to 2,000L in addition to adherent processes at various scales. We rely extensively on single-use and disposable technologies in both upstream production and downstream purification to allow cost savings while reducing potential risks of product cross contamination.

We have scaled up to 2,000 L for multiple gene therapy programs and we are ready to take on your AAV, lentivirus, adenovirus or oncolytic virus manufacturing project at any point from concept to patient. We can support programs with process and assay development, clinical manufacturing and commercial production.