viral vector manufacturing

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 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 and towards the commercialization of your therapy.

While we run your process, we'll 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.

A home with room to grow

Our 300,000 square-feet dedicated cell and gene therapy facility in Houston, Texas is designed by experts in cell and gene therapy to address the key challenges in the manufacturing of these therapies and the critical product supply needs of our customers.

The world’s largest dedicated cell and gene therapies (CGT) manufacturing facility at its opening in 2018, our Houston site is now approved for commercial manufacture.

The modular designed cleanroom can be custom built to fit our client process needs in the existing shell space with a cost-effective and time-efficient manner. By working side-by-side with our clients in the product development life-cycle, we are de-risking your path to commercialization together, from developing regulatory-compliant industrialized process to securing cGMP capacities to meet market demand.

 

Scalability at your fingertips

Our facilities and processes are built with scalability in mind. In 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.

Technologies