Viral Vector Manufacturing
The Center for Breakthrough Medicines has the world’s largest single-site viral vector manufacturing facility, with over twenty suites focused on scalable production of viral-based therapies, including Adeno associated virus (AAV), Lentivirus (LVV), HSV, and Adenovirus.
This state-of-the-art site is operated by a world-class team representing some of the most experienced personnel in the relatively young viral vector market. Our platform solutions efficiently and consistently deliver high yields without compromising quality, accelerating the availability of new therapies to patients who need them.
- Starting material, drug substance, drug product, and custom sterile components and buffers
- Support for client programs throughout the entire product lifecycle from development to commercialization in both adherent and suspenction batches up to 2,000 L
- Access to a proven, scalable platform process licensed from UPenn GTP
- Allocation of a Scientific Program Leader and a Project Manager to oversee every project, ensuring smooth tech transfers and full transparency throughout your Viral Vector customer journey
- Partner in Plant model that offers flexibility for you to work alongside our subject matters experts in our Process Development Labs, to be present during GMP operations in our manufacturing suites, or to remotely monitor your runs via live streaming from the suites
- All projects lead by strategic product development to drive flawless clinical and commercial GMP manufacturing
- Manufacturing and release testing of both raw materials and product destined for clinical trials and commercial supply are performed under cGMP and our ISO 9001 quality system. This process is conducted right across the hall from manufacturing
- Option of a dedicated custom cGMP suite under a Long-Term Service Agreement
Facility Design
Multi-product facility designed to meet clinical and commercial requirements
Engineering controls to promote and ensure segregation and contamination management
High Throughput suite designed to support 15-30 batches per year and safegaurd capacity
Single Pass AHU strategy
Custom buffers and component prep areas
Multiple warehouse locations
Starting Materials
Cell banking
Viral stocks and viral banks
Reference standards