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.
We produce AAV using various processes ranging from HEK293-based transient transfection, Hela cell-based producer cell lines with Ad helper infection to recombinant baculovirus-based methods with insect cell lines to process.
Our proprietary clonal HEK293-based suspension processes for transient transfection are designed to be scalable and robust for your AAV production needs.
Our teams have experience in providing lenti process development and GMP production services using both transient transfection and stable packaging cell-line-based processes.
We can produce vectors with either adherent or suspension-based platforms and remain flexible to address your needs.
We also produce adenoviral vectors and oncolytic viruses. We have worked with various host cells and support both adherent and suspension-based processes.
Our group produced Adenovirus Type 5 Reference Material in 2001 for industry to be used to validate internal reference materials and assays.
Why choose us?
- 20+ years of cell and gene therapy GMP expertise
- >120 process development projects in cell and gene therapy
- 2000 L AAV: First CMO to manufacture AAV at 2000L
- Track record of >50 viral vector customers served
- Proprietary scalable manufacturing platforms for AAV, lenti and adeno viruses
- Flexible capacity for viral vector manufacturing at our Houston facility
- Regulatory support throughout your clinical and commercial journey
cell and gene therapies
our global network
Portsmouth, NH, USA
Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing
Production, Sales & Support
Houston, TX, USA
Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Viral Vector Manufacturing