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The safe manufacture of pharmaceutical drugs requires perfectly sterile and particle-free environments. A rapid transfer port, which comprises double containment doors that are integrated into an isolator, is a system that allows the safe transfer of substances used in drug development, such as active pharmaceutical ingredients or vaccines
ABC Transfer, an industrial designer and manufacturer of secure Rapid Transfer Systems (RTS) for the biopharmaceutical industry, recently announces that it has raised €3 million in a series A financing round. Go Capital, an investment fund management company and representative of the Loire Valley Invest Fund, led the round, with Bpifrance, the French national bank and the regional government of Centre-Val de Loire contributing grants and loans.
The success of this first tranche of funding reflects investor confidence in ABC Transfer’s business model and leadership team, as well as strong interest in the market opportunities that its aseptic transfer systems will be addressing. Growth of the pharmaceutical industry and the rise in research and development are likely to drive the demand for aseptic filling, thus boosting the global aseptic transfer system market.
The drug manufacturing shift to smaller and more flexible production lines is expected to impact growth for these systems. Dr Kevin Robinson spoke with the company’s President, Thierry Girard, to find out more.
In the beginning
“Everything started with a couple of discussions with customers in the pharmaceutical industry about manufacturing vaccines, ingestible drugs, etc., in a sterile environment,” explains Thierry.
“As cofounder Jean-Luc Schneider and I have a lot of technical and executive management experience in that sector, we identified a gap to fill in terms of the compliance of existing rapid transfer port systems, the way customers operate them and they way they’re maintained in the factory. We realised there was a problem or, in fact, a collection of problems, so set out to find products that would provide the necessary solutions.”
“Interestingly, we created a list of about 50 different issues: some to do with GMP compliance, others with patient safety , ergonomics and the overall ability of operators to ensure the sterility of their processes. We asked production staff about the difficulties they faced every day, discussed maintenance and efficiency issues, for example, and what needed to be done to overcome these hurdles,” he adds.
“Some of the improvements we came up with are small, some of them are larger. The external opening of our alpha rapid transfer port (RTP), for example, addresses every single one of the 50 issues we identified. In essence, we are bringing a set of solutions to the market that have been designed from scratch.”
“Although starting with a blank sheet of paper and not copying existing solutions were somewhat daunting, it meant we had to reinvent everything, which gave us the freedom to do the right thing in terms of compliance and GMP requirements such as the new EU GMP Annex 1.”
“Our products are easier and safer to operate and maintain,” Thierry enthuses: “Protected by 12 patents, we believe our ABC Transfer system is the very first of its kind to satisfy all the demands placed on RTS in biopharmaceutical manufacturing. We listened to customers, addressed their issues problems and shortcomings, and we’re now showing the first prototypes to interested parties. We’re aiming to launch our first product in the fourth quarter of this year,” he adds.
The coronavirus effect
Given the ongoing COVID-19 pandemic, I ask Thierry whether the coronavirus has put more pressure on the industry in terms of sterile manufacturing and, as a result, generated more interest in their new products. “Currently, with products being trialled by customers, we still need to finalise the actual design.”
“Then, we can start the validation stage of the process. So, we can’t offer an instant solution, right now, but hope to have items available in October or November this year,” he says.
“But, you’re right. There is a lot of activity in the industry and a lot of pressure on existing suppliers, particularly those involved in the supply of products for the preparation of a COVID-19 vaccine. Today, a lot of companies are ramping up their production capacity to be able to mass produce a vaccine as soon as it’s been approved.”
“Of course,” he adds, “we’re keeping a close eye on what the regulatory bodies are saying, whether that’s in the US, UK or China, but, regardless of COVID-19, there is a much stronger focus on companies to improve patient safety, to firm up process quality and control, and increasing pressure — at least in continental Europe — to look at ergonomics and operator safety. These underlying needs are paramount, whatever the prevailing conditions.”
Although the company’s recent press release highlighted biopharmaceutical applications, I wonder whether they’ll also be relevant for traditional solid dose manufacturing. “Yes,” says Thierry: “Every time a customer in the pharmaceutical industry needs to use an isolator, we have to provide an applicable solution.”
“Whether that’s the production, weighing or packaging of active ingredients, for example, or the transfer of tools, components, products or waste into or out of an isolator, the same system requirements exist for both traditional or bio-based processes and we’re aiming to address both markets.”
And, on the topic of the burgeoning highly potent actives market, Thierry explains that they’re also researching solutions for nano-scale drugs and powders. “It’s an area we need to explore,” he says, “because we think that our products are much more leak tight than existing ones and we’re optimistic that they’ll also be able to handle very fine powders. There’s a definite gap in the RTP market for these applications.”
Thierry notes that the isolator market is growing at about 10–15% per annum, boosted by the actions of various regulatory agencies who encourage the use of such technologies. In addition, single-use products continue to gain momentum as they eliminate any issues with cleaning regulations and cross-contamination.
Benefits and risk reduction
Given that the pharmaceutical industry is quite conservative, I ask Thierry whether integrating any of the company’s new productions, and the subsequent need for revalidation, would be an issue. “Perhaps not an issue,” he offers, “but certainly a hurdle that has to be jumped. We’re working in an industry in which patient safety is extremely important and anything novel is looked at as a risk.”
“Without doubt,” he continues, “every time you change something, you introduce a risk. What we can do is minimise that risk and help customers to understand how we do that. So, for example, our products will be compatible with most existing RTPs and we’ll demonstrate that as part of our validation process. It’s also our responsibility to implement a comprehensive Quality System so that, from a documentation standpoint, we minimise any perceived risk.”
“Then it’s up to the customer to decide. They must weigh up the benefits of the innovations we’re bringing them against the risk of introducing something new into the production line or laboratory. We appreciate that it’s going to take some time for the industry to accept our products, but it’s something we’ve discussed openly with our investors.”
“Our business case is very much based on an extended timeframe because, no matter how good and beneficial we think our innovations are, it’s going to take some time for them to take root.”
Taking a positive stance, I suggest that the successful Series A financing means that, already, Big Pharma has recognised the need and applications of these products, which has got to be a good thing.
“Indeed,” agrees Thierry: “So far, the feedback has been very good, people are seeing the benefits and, even since the announcement, we’ve had a number of enquiries from companies that we hadn’t previously liaised with. We’re trying to do the best we can but, it’ll be up to our customers to determine whether it’s a success or not.”
Clean and green
Further to the functional benefits of the company’s RTS, Thierry is also keen to discuss their green credentials. “Although it’s not an industry requirement, one thing we’re are very passionate about, as an innovative start-up, is how we can design and manufacture in an environmentally responsible way, how can we design them to minimise the consumption of natural resources. We want them to use less material than previous-generation versions, for example, or competitive products, and we’ve engineered them to be 100% recyclable.”
“As business owners, we feel we have a responsibility to the environment and want to do our best to minimise our impact,” he continues. “We strongly believe that companies that don’t adopt green initiatives won’t be here in 20 years’ time. But, as global citizens, adults and human beings, we should be doing as much as possible to protect all life on Earth.”
In closing, Thierry reminds me that the soon-to-be-launched product range started life in the nuclear industry. “It doesn’t matter,” he says, “if you’re working with ingredients for radiotherapies, nuclear waste or highly potent molecules, it’s all about how you protect the operators from harm.”
“Yes, our product concepts were invented in the 1960s in France and the US, then were redeveloped during the 1980s for pharmaceutical use. There are certainly applications beyond bio/pharma, such as radio and nuclear pharmacy, but, for now, we are 100% focused on the pharmaceutical industry. Now and for the foreseeable future, there’s a lot to do, an awful lot to do.
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