“Polio as we know has been an oral vaccine for quite a number of years,” Ron Lowy, Chairman and Chief Executive Officer, PharmaJet Inc., told us. Lately, though, the industry has been moving away from an oral to an injectable polio vaccine.
“Over a period of time, there have been some concerns that the polio virus begins to mutate,” said Lowy, “In order to get head of that they are moving from oral to an injectable.”
However, the problem with an injectable polio vaccine, is there isn’t enough capacity to support the level needed.
To address this issue, PharmaJet did a study with WHO and The Gates Foundation in Cuba, which showed that if a polio vaccine is injected intradermally, as opposed to a normal intermuscular or subcutaneous injection, significantly less vaccine can be used – nearly 80% less.
“That’s really the key to this,” said Lowy.
While intradermal injections use less vaccine, the biggest issue is that they are difficult to do.
“It [the injections] can also be relatively inconsistent, added Lowy, “and the idea that you have to train someone how to do it can be a bit daunting.”
As such, PhamaJet developed its Tropis device, which Lowy said makes it “very simple” to do an intradermal injection. “It’s also relatively less painful and is done in about a 10th of a second,” he added.
The device works by delivering medications and vaccines intradermally via a narrow, high velocity fluid stream, which Lowy said prevents needle-stick injuries, needle re-use, and cross contamination or spread of diseases.
Lowy also said the device is able to vaccinate five times as many children with the same amount of vaccine and it takes as little as 20 minutes to train someone how to use the device.
And the company has already started train-the-trainer programs, bringing in trainers from different countries that will pass along the knowledge to others back in their country, as part of the WHO’s global effort to eradicate polio.
“They’ve [WHO] put in a significant size order in the millions that we plan on beginning to provide at the end of this coming year and in the first quarter of next year,” explained Lowy, who added that the company expects follow on orders.
Outsourcing
With an order size in the millions, PharmaJet is ramping up production with its Wisconsin-based CMO Phillips-Medisize.
“The way we’ve set up the company is we handle all of our own design and engineering in-house, as well as key account management, but we outsourcing all of our manufacturing,” explained Lowy.
The company also outsources distribution, packaging, and sterilization
“We look for world class outfits to play with,” said Lowy. “These syringes are in the multiple millions, so you really want to find a manufacturer that has the capabilities of doing both the tooling and the manufacturing for millions and million at six sigma quality levels.
“The last thing we want is for someone to be injecting children and have a quality issue at that point.”