Cell and gene therapy (CGT) is one of the most promising procedures in modern medicine, offering patients the chance to be cured of a range of conditions.
The procedure comes in a range of different forms, but usually begins by extracting a person’s cells or genetic code.
This material could also come from a donor in some cases, and is then medically altered so it can learn how to fight certain or treat diseases like cancer, AIDS and heart disease.
The cell or gene is then placed back in the patient with the ‘blueprint’ of how to fight these conditions.
Despite the fact that there are so many benefits to CGT it remains largely inaccessible for the average person.
There are multiple reasons for this, with the main one being cost. One round of the therapy alone can cost anywhere between US$500,000 all the way up to US$2 million.
Logistics play a big part in this, with cells often frozen and sent around the world to labs to be modified which can leave some patients waiting months for a therapeutic product.
OriBiotech is one organisation that is looking to change this, bringing the therapy to people across the world.
This has the chance to save countless lives, something that Jason Foster, CEO and executive director at OriBiotech, says is the company’s biggest goal.
“Cell and gene therapy represents a cure,” he said. “For many patients they would have died otherwise, it really is a life or death scenario.
“The biggest challenge for the industry is how do we make it in a cost effective way and make it widely available for patients.
“Today’s processes are highly manual and because of this these skilled operators are in high demand. There aren’t enough people to do these jobs.
“Those things combined together, alongside the complexity of the logistics, make the process inefficient.”
These common problems are what OriBiotech is looking to tackle.
Through its bespoke manufacturing platform the company is attempting to bring more automation to the process.
On top of this it is looking to set up more sites to where CGT can be carried out, allowing the therapy to be done at a much faster rate.
Less travel when it comes to transporting cells ultimately brings the cost down, which in turn leads to more access to patients.
“It’s a unique challenge,” Jason said. “Both for the industry, who’s never had to manufacture in this way before, but also for the logistics in the supply chain.
“It’s a very complicated process today. It’s very expensive and logistically challenging and unfortunately, because of that these products end up being very expensive.
“This means very few patients can actually access it, so only around ten to 20 per cent of the patients that can benefit will actually be able to get access.
“There’s almost ten million people a year that get diagnosed with cancer, and another two million that die of this, so this could have a huge impact on patients.
“It’s a super exciting field to be involved in and we hope that we can have a big impact.”
After being founded in 2015, Ori is now only around 18 months away from bringing these therapies to a wider patient audience.
The company has now begun forming partnerships for this in both the UK and US, while also collecting a range of patient data and feedback.
It is now in the clinical stage with various tests and trials and its developers are looking forward to its potential when it is expanded.
“If there’s two words that you can take from OriBiotech it’s flexibility and scalability,” Jason said. “We’re currently in the early phases of helping our partners perform process discovery.
“In cell and gene therapy the process is our product, so what you do to the cells actually has a huge impact on what ultimately the therapeutic product looks like.
“If you’re discovering how to manipulate these cells in the right way and doing that process discovery more efficiently then we will have a seamlessly scalable product.
“The industry has really struggled with that transition: the comparability of the commercial process with the clinical side.
“So what Ori offers is to seamlessly scale that into the clinic and ultimately to the commercial stage so those compatibility challenges are no longer an issue.”
The platform has been through hundreds of test runs now and has successfully demonstrated its success at making CGT seamless.
Its potential has gained a lot of attention, with Jason saying most of the feedback the company had received was that of excitement.
This has been from all over the world and that is exactly what the company is looking for as lack of access to CGT is a global issue.
“OriBiotech should be a global platform so it can provide a potential path to treating hundreds of thousands of patients.
“We can run in a one thousand square feet facility and we can produce 30 doses in parallel, up to one thousand doses per year.
“So it’s an order of magnitude difference, it’s a 95% reduction in the facility size that you need to have the same amount of throughput.
“The hope is to be able to build out manufacturing capacity much closer to patients which is an exciting opportunity for Ori.”
CGT is such a broad field, but Jason has already alluded to the platform’s potential when it comes to other brands of healthcare.
“Ori is specifically targeted to what they call living medicine, so we’re using cellular based therapies.
“But recently we have been thinking about its ability in viral vector manufacturing and other types of large-scale manufacturing.
“Right now, we are very focused on cell therapy and gene modified cell therapy, which is a very large category in itself, but there’s certainly future applications where we can see the platform being useful.