Scientists developing vaccines for potentially deadly diseases like influenza, SARS and HIV struggle to find a CRO with the right capabilities according to contractor TNO Triskelion.
The Dutch contract research organisation (CRO) made the comments after opening an laboratory and production facility that complies with US Centers for Disease Control and prevention (CDC) Bio Safety Level 3 (BSL-3) standards, which are the standards required for handling dangerous viruses.
It is hard to estimate how many BSL-3 production sites are operating around the world. A recent report by the US Government Accountability Office (GAO) stated that there were 1,356 in the country, however no more recent data is available.
According to John Dulos, senior project manager at TNO, such capabilities are rare.
He told Outsourcing-pharma.com that: “A contract research organization in which class 3 viruses and bacteria deadly to humans can be studied in conformity with Good Laboratory Practice (GLP) is unique in the world.”
In addition to this gap in the market, the continuing emergence of new diseases was another key driver for TNO’s investment in the new facility according to Dulos, who said that drug industry demand is growing.
“Outbreaks of new or re-emergent virus strains are always of interest. It is of great interest to “chase” viruses that have a potential to mutate and pass the barrier of species to prevent pandemics.
He cited Middle East respiratory syndrome coronavirus as an example, explaining that the virus “sickened 182 people and killed 80 in 2012 is on the watch list as it is from the same family as SARS that killed more than 700 people in 2003.
“MERS does not transmit from person to person as easily as SARS which suggests that it probably transmitted to human via animals.”
Concerns about a potential influenza pandemic are also likely to create work for the TNO facility said Dulos adding that: “Since the H1N1 almost-pandemic, the authorities are very careful with new Flu outbreaks such as H7N9 in 2013. It’s a constant surveillance.”
To gain accreditation for the new BSL-3 facility TNO had to upgrade air handling and liquid waste management capabilities according to Dulos, who told us the firm will also start using new virus propagation techniques and assays as part of the work conducted at the lab.
He added that: “Additional staff is already in house but there will be additional growth of staff in the near future.”