Many of today's vaccines are produced on animal-derived substrates, including fertilized chicken eggs and mouse brains. These processes have inherent problems due to limitations in scaling of manufacture, processing time, and success rate due to potential safety risks associated with the use of animal-derived substrates. With its unequaled safety profile, high performance in multiple culture and production formats the PER.C6^® cell represents a state-of-the-art production technology allowing reliable and flexible manufacturing of safe and efficacious vaccines.

PER.C6® cells support growth production of many viral vaccines.

Many viruses have been demonstrated to efficiently replicate on PER.C6^®

cells. Because of the high titers reached, PER.C6^® cells provide excellent bulk material for processing and final formulation of inactivated whole virus, subunit and live recombinant vaccines. Viruses demonstrated to grow to very high titers include influenza, Japanese encephalitis, Respiratory Syncytial and parainfluenza viruses. Crucell continues to identify viruses that grow efficiently on PER.C6^® cells for future therapeutic applications.

In addition, Crucell’s PER.C6^® technology, by virtue of its design, allows for efficient production of recombinant live adenovirus vector based vaccines (see AdVac® technology).

Crucell operates fully functional research and development laboratories at Biological Safety Level I, II, and III with integrated upstream and downstream capacity. These units are used to develop in-house products that require different biosafety level handling. In addition, Crucell’s BSL II and III facilities allow in vivo testing for product safety and efficacy.

In its GMP production facilities, products for clinical testing are manufactured from viruses produced on the PER.C6^® cell line in bioreactors at 30L to 100L scale. At present, Crucell is expanding its GMP-production capacity to 100L working volumes. PER.C6^® technology is being used in Crucell’s programs for the development of vaccines against Ebola, malaria, West Nile disease and influenza.

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