AdVac® technology is revolutionary

AdVac® technology enables the development of recombinant vaccines based on rare adenovirus vectors, such as Ad11, Ad35 and Ad49, and derivatives thereof. As pre-existing immunity against these vectors is very limited, they allow effective delivery of small fragments of otherwise deadly pathogens to the immune system using a replication-incompetent adenovirus vehicle.
 
AdVac® vaccination vectors can be manufactured to high titers on a PER.C6® cell substrate, which is the only cell-based manufacturing platform that does not allow replication-competent adenovirus to form during the production process. AdVac® vectors combine all the advantages of the adenovirus vectors commonly used for vaccination, such as high production yields, strong immunogenicity and an excellent safety profile, together with accurate dose control of the vector-based vaccine. Thus, Crucell’s AdVac®-based vaccines are expected to deliver consistent results in clinical studies.

AdVac®-based vaccines show high efficacy

AdVac®-based vaccines against malaria, HIV/AIDS, hepatitis C, hemorrhagic fevers (Ebola and Marburg) and tuberculosis have been successfully constructed and have shown very promising results in preclinical and clinical tests conducted to date.

 

In preclinical vaccine models , these AdVac®-based vaccines elicited strong CD4 and CD8 T-cell responses, as well as potent and neutralizing antibody responses. In all instances, the high immune response elicited upon vaccination against the pathogenic antigens resulted in complete protection of the vaccinated animals  upon high-dose challenge, demonstrating the strengths of Crucell’s proprietary AdVac® vectors. The available data from phase I and II clinical trials of AdVac®-based vaccines confirm these findings. For example, the Ad35-based tuberculosis vaccine Crucell is codeveloping with Aeras produced the highest human CD8 T-cell responses seen in any tuberculosis vaccine trial when it was tested in adults previously immunized with BCG (the existing tuberculosis vaccine, which has very limited efficacy).

AdVac® vector-based products from bench to clinic

Crucell has fully operational BSL-II laboratories with integrated upstream and downstream capacities up to a 10L scale. These units are used to develop purification methods closely resembling an end-stage manufacturing process. With this facility, Crucell has the ability to manufacture Ad11 or Ad35 vaccine vectors for comprehensive preclinical programs. Crucell has a fully operational GMP facility that has been designed as a multi-purpose production plant, which allows for the production of clinical-grade vaccines based on live vectors such as recombinant adenoviruses. These products can be manufactured using PER.C6® technology under serum-free conditions in formats ranging from roller bottles to bioreactors. Crucell is expanding the GMP production capacity to 100L working volumes.