However, this means that the manufacture of such therapies needs to move at the same speed, which has seen those involved in the space speculating how the field will look ‘two to three years’ in advance of where it is currently positioned.
Facing down this challenge requires expertise and a pool of employees to select from, which has led to national governments forming partnerships with industry to bring through the next generation of talent.
When speaking to BioPharma-Reporter (BPR), eXmoor’s managing director, Angela Osborne (AO), told us that the issue regarding filling this skills gap will become more pronounced in the years to come.
Specifically, Osborne explained that research had revealed that demand for employees was set to double in the advanced therapy sector over the next five years.
BPR: Could you outline the work that eXmoor does?
AO: eXmoor works with companies which are just embarking on taking a product from research into development, through the clinic and then commercialisation. Often, it’s spin-out companies which are just getting started; they have a product and a research process, but they want to know how to get to Phase I, how long it will take, how much it will cost and what is involved.
We also work with businesses which are at a later stage of maturity and are considering building a facility, but they are not sure whether to use a CMO. In this instance, the eXmoor team does a ‘build or buy’ analysis for them. If the company does decide to buy the capacity, we might help it select a CMO then support its tech transfer from there. If the right answer is to build a facility, we help the business with the design.
We offer quite a diverse range of services, but they're all in the manufacturing space.
BPR: Once a company reaches the commercialisation stage and has a settled manufacturing process, is that the end of your work?
AO: Most companies have a pipeline of products; after one product has been brought to market, there are others following on that aren't yet there. Even with the products that are on the market, there's often more facility work to do. An initial facility will get a company going for the first few years, but it will eventually need to expand.
For cell and gene therapy, that stage hasn’t been reached yet. Currently, it’s facilities for clinical trials or more recently facilities for commercial products. Companies aren’t yet addressing growth following early manufacture because the markets aren’t there.
In 2005, we began developing processes and facilities for cell and gene therapies, and it soon became clear that this was going to be a huge market. It also became apparent that a plethora of different skills were required in order to work in that area.
Those bringing the products through were coming from academic backgrounds and had a limited understanding of GMP manufacturing or process development. So, eXmoor brought in different people with the skills to help these companies progress from research to commercial manufacturing.
The way we've developed as a company is by following the demands of the market.
BPR: How do you work with a client to design that facility that meets their needs?
AO: The right place to start is: “I want to make so many doses or batches of these different products to meet this market and it's going to change over time like this.”
So, eXmoor begins with the definition and the high-level business objectives. Once those are nailed down, the design is relatively straightforward and is developed to deliver the technical and business need. At this point, it doesn't matter exactly where the site is or what the building looks like. At a later stage, we need to address exactly what shape the building is, how you get people and materials in and out and what services are available, etc. in order to develop the conceptual designs. But, in the initial phases, that information isn’t required.
BPR: What kind of advice do you give to companies when they're looking for a CMO?
AO: eXmoor now has a well-honed process which involves telephone interviews, pre-qualification, qualifications and so on. Crucially, it comes down to capability and capacity. Does the organisation have the capability to operate the kind of process that you want it to? Does it have the capacity to do it when you want it to? Once you arrive there, how much does it cost?
In terms of finding the ideal or the optimal CMO, I would say there’s no such thing, really. There is no perfect company out there. Our experience is that it’s really important to choose the company that best fits what you want but know where its weaknesses are, so that you can put steps in place to mitigate them.
A number of our clients have said that CMOs are good if the process is really locked down but if it’s not that robust, that's when they struggle.
BPR: Is this knowledge gap a major problem? How is it being addressed?
AO: It was definitely one of the early and most common issues because not only did our initial clients not know the process, but they had no understanding of how much things would cost. At the beginning, clients thought that if a GMP facility was designed for them and they put their research process in there, it would be GMP compliant.
However, more recently, eXmoor has been working with some well-funded spinouts boasting switched-on teams with experience in biopharma or from other cell and gene therapy companies. These teams have a much better idea of how long things take, the costs and roughly what’s involved.
At the moment, there’s undoubtedly a huge skill gap. In London, companies have low retention rates and employees are constantly moving around because no sooner do they start somewhere, they are headhunted by somewhere else. It’s a big issue, which we're trying to address.
BPR: How is the industry reacting to the skill gap?
AO: We co-founded the amc (ATMP Manufacturing Community) in 2010 because we felt that the manufacturing community needed somewhere to discuss its problems and share solutions. The amc holds two technical meetings per year attracting 100 delegates each. Next March will be our 20th meeting.
The amc is leading an initiative called AToMIC (Advanced Therapy Manufacturing Industry Consortium) aimed at ensuring more graduates and postgraduates enter the market with the skills required by industry. To do this, we worked with ten organisations which were all facing a skill shortage and they each put some money into the pot.
We're using that money to steer and focus a number of university courses, specifically aimed at different elements of ATMP [advanced therapy medicinal products] manufacturing. This has been done not only to secure those courses, but also to host an annual event where the consortium members meet the students so that they have better access to recruiting those students out of university. This is clearly only one small solution to a big problem.
BPR: What is the scale of this issue?
AO: Thinking back to some initial research into the skill gap that eXmoor did, estimated numbers indicated that over the next five years, we needed another 500 people in manufacturing in the UK to add to a total that was only 500 already. We needed to double our numbers, which obviously says a lot about the situation, especially when spin-out companies are aiming to grow from two people to 100 people in six months.
BPR: How is Brexit having an impact on this shortage in the UK?
AO: Brexit is having a massive impact; we're even seeing it amongst our own staff because, in our labs in Bristol, more than half of our staff are not UK nationals. They feel really uncomfortable at the moment because they feel unwelcome in the UK.
Beyond this, we are seeing a direct impact when it comes to clients deciding where to site a facility. Prior to Brexit, the UK would have been a definite consideration, but now companies aren’t sure or are definitively deciding against the UK.
Angela Osborne is managing director at eXmoor Pharma Concepts, which she founded in 2004. Angela has a BSc and PhD in Biochemical Engineering from University College London and over 30 years’ experience in biopharmaceutical and cell and gene therapy businesses, processes and facilities.