A Connecticut bioscience company has decided to go ahead with production of a swine flu vaccine.
But Protein Sciences in Meriden says it's still waiting for a decision on a government contract that would help it expand its manufacturing capacity.
One of the buildings at Protein Sciences’ headquarters is nearly half filled – with a big empty space….
"So this is going to be where we intend to put a very large scale manufacturing facility… "
CEO Dan Adams has had plans for this area for a long time – a facility that could turn out 100 million doses of vaccine each year, key infrastructure in fighting a pandemic. But Adams says, such a venture needs government backing.
"For H1N1, as a pandemic vaccine, there’s no assured market for that. We don’t know whether anyone would buy it if we made it, so it’s very difficult for especially a small company to start making an H1N1 pandemic vaccine, when as happened in 1998, the whole thing peters out."
The company is just months away from FDA approval on its groundbreaking vaccine production method. Most vaccine production uses chicken eggs infected with the live virus as incubators, but Protein Sciences instead uses insect cells, in a cleaner and quicker method. The cells are infected with a harmless baculo virus, that acts as a kind of template – scientists can splice on the genetic code for any disease that they want to make a vaccine against. This is called recombinant DNA technology. Other companies are working on similar techniques, but none are as close to approval for a commercial product as Protein Sciences.
"Insect cells will make anything….all we have to do is change the virus, so we can change from making a flu vaccine to a diabetes vaccine, to a hepatitis B vaccine – we can just change by just changing the code on the baculolovirus.….if we want to change to making an H1N1 vaccine, it’s a Friday to Monday thing. We clean the bioreactor, and we start infecting it with the code for H1N1."
Protein Sciences has decided to take a chance and go ahead with production of an H1N1 vaccine, encouraged by positive signs from the US government, and an invitation to apply for fast track approval in Europe. Having done a lot of the preliminary work already, the company now says it can turn out 100 thousand doses of swine flu vaccine by the week of June 8th. Companies using egg based technology are still months away from an H1N1 product. But says Adams, up until very recently, government dollars have been focused on those older methods.
"Historically the large pharmaceutical companies have gotten the money – they’ve been paid hundreds of millions of dollars to establish capacity for basically old technology. I understand that you need to have people who can turn out a lot of doses, but the egg process is a slow process."
In 2006, the federal government set up BARDA, the Biomedical Advanced Research and Development Authority, a division of the Department of Health and Human Services, as a response to the outbreak of bird flu that threatened a pandemic. Dr Robin Robinson, head of BARDA says he does see the agency’s role as promoting the development of new and better technologies.
"Our motto has been leave no stone unturned. We’re always looking for more capacity, and certainly vaccines that can become available sooner."
By 2011, the federal government aims to have the capacity ready in the US to turn out 600 million doses of vaccine within 6 months of a pandemic being declared, so manufacturing infrastructure like that planned by Protein Sciences is key. Fifteen months ago, the Meriden company applied for a contract with BARDA which would allow it to go ahead with its new facility. But despite encouraging noises, there’s still no concrete announcement on the money. That’s in contrast to the Mexican government, which gave preliminary approval for Protein Sciences to set up manufacturing there within a week of contacting the company. Robinson admits that sometimes allocating cash for development of vaccines doesn’t move fast.
"Sometimes not as quickly as I would like or others would like, but we’re always finding ways to do that quicker. We’re always working to move faster on this."
In a lab just down the corridor from where the new manufacturing facility is still on hold, Dr Clifton MacPherson and his team are running tests. He says there's a little extra pressure with their new mission.
"For the most part the production process is the same as for the other proteins we’re making a the tests are the same. It’s a little bit higher pressure because there’s potential for a true pandemic, and lots of people getting sick, and we wanna push to get it out the door as quick as possible."
The panic over swine flu seems for the moment to be easing, as the virus proves to be less lethal than was feared. But Dan Adams says as global warming forces human populations into what was previously wilderness, we come more and more into contact with animals, and their viruses.
"Whether this H1N1 has legs or not, we’re going to see these things, not every 15 or 20 years, we’re going to see them every 2,3 years. We’d better have the tools that we need to address things quickly."
The WHO recently advised vaccine manufacturers not to disrupt their production of seasonal flu vaccine in order to focus on swine flu, fearing a shortage of the regular vaccine come fall. Protein Sciences believes with the right investment in its faster and more responsive technologies, such tough choices might no longer be necessary.