Xcellerex has agreed to help Novavax accelerate the development of its vaccine manufacturing process to commercial scale. The aim is to begin immediate production of Novavax' H1N1 influenza, or swine flu, vaccine for potential commercial sale.
Earlier this week Novavax launched a two-stage, 4,000-patient study of its H1N1 flu vaccine in Mexico to support registration in that country.
The two companies will utilize Novavax’ virus-like particle (VLP) vaccine technology to produce initial commercial quantities of H1N1 vaccine with Xcellerex' FlexFactory biomanufacturing platform. Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing supply fees from Novavax.
“This alliance will also enable us to establish commercial-scale production capabilities for our VLP-based seasonal influenza vaccine program and significantly advance our timeline for full-scale manufacturing,” reports Rahul Singhvi, Novavax’ president and CEO. The company’s seasonal flu vaccine is in clinical development, and it also has a bird flu vaccine in preclinical studies.
Additionally, Novavax has designed vaccines against respiratory syncytial virus, varicella zoster virus, and HIV. It recently launched a joint venture with Cadila Pharmaceuticals to develop and manufacture vaccines, biological therapeutics, and diagnostics in India.
Xcellerex’ FlexFactory is a portable manufacturing platform based on the application of single-use technologies, controlled environmental modules, and various process automation techniques including electronic batch records. The FlexFactory eliminates clean- and steam-in-place and cleanroom infrastructure, simplifies facility design, and creates breakthrough gains in operating efficiency, flexibility, as well as environmental friendliness, according to Xcellerex.