Janssen has opened a single-use manufacturing facility in Leiden, the Netherlands to support the commercialization of its preventative HIV vaccine candidate.
Commissioned in 2014, the multipurpose vaccine production facility is being inaugurated today (Thursday October 25) in Leiden, the Netherlands and will initially be used to manufacture the firm’s investigational mosaic HIV-1 preventive vaccine. The facility represents an investment of €72 million ($82 million).
The facility came about following the 2014 Ebola outbreak in West Africa, Dirk Redlich, VP of strategy and operations leader at Janssen Vaccines told journalists during a recent press trip to the Netherlands.
At the time, Janssen’s facility in Switzerland made small volumes of an investigational preventive Ebola prime-boost vaccine regimen – two million doses at 10L scale. But it was deemed necessary to have a large-scale facility to prepare for commercialization of various vaccines, Redlich said, and thus the decision was taken to construct the site in Leiden.
The plant is equipped with single-use bioreactors to a scale of 1,000 L. Using the human PER.C6 cell line to make the adenovirus vector, “we can produce anywhere between 100 and 300 million doses of vaccine with a rather small 1,000 L volume,” depending on the disease, Redlich said.
HIV vaccine: The ‘holy grail’
The first product to be made at the site will not be an Ebola vaccine, but a preventative HIV vaccine.
Janssen, a subsidiary of Johnson & Johnson, has been involved in the HIV space since acquiring TiboTec Therapeutics in 2011. Tibotec was the first company to enter the market with an effective drug, which, in combination with other drugs, changed HIV infection from a deadly disease to a treatable disease adding.
Despite this success, HIV is still a major issue with 40 million people living with HIV or AIDS globally, 22 million of which do not have access to therapies. A preventative vaccine against HIV would, therefore, be “the holy grail,” said Hanneke Schuitemaker, VP of viral vaccine discovery and translational medicine at Janssen.
She pointed to Janssen’s HIV vaccine, which is moving through the clinic and is currently in the Phase IIb stage.
According to Janssen, the candidate has positive characteristics including being stable at temperatures up to 28°C. Janssen’s platform has also been shown to both elicit antibody responses and cellular responses, and the virus has been engineered to not be able to replicate once injected.
“The PER.C6 cell line has a sequence which allows the virus to grow,” explained Redlich. “The sequence allows the virus to grow through a highly efficient platform so you can grow viruses in numbers not seen before. Normal cell lines have about a million cells per ml, but we can have up to 100m cells per ml.”
The primary analysis of the Phase IIb proof of concept study is planned by 2021.