Contract research, development and manufacturing organisation (CRDMO) Ingenza has increased its operational footprint and signed an alliance to support the development and GMP manufacturing of biotechnology products as it looks to expand.
Ingenza focuses on biologics, enzymes and other proteins needed for the pharmaceutical sector, and innovative, sustainably manufactured products and technologies for markets such as consumer care, agriculture and advanced materials. The company recently signed a strategic relationship with nearby Ab Biotechnology – a MHRA licensed GMP facilities provider – to provide a seamless pathway from CMC development to scalable manufacturing of material for first-in-human studies.
The company has also moved into a new, custom-designed, multi-million-pound facility outside Edinburgh, UK, which more than doubles its operational footprint. The design of the building – which had its formal opening in October - will allow Ingenza to scale biomanufacturing to 100 L paving the way for the production of cGMP clinical material.
The company has also recently launched ‘UnvAIl’, an AI and machine learning service that uncovers unique biocatalysts and other proteins with properties superior to current industrial benchmarks. It does this by searching public sequence datasets to identify distantly-related homologues to reference proteins, then predicts their solubility, structure, beneficial mutations and other key features to identify those most likely to demonstrate significantly enhanced activity, stability and solubility.
It’s a growth time for biologics, says Ingenza chairman Dr Ian Shott.
“Biologics have led the top selling pharmaceuticals for years, but the reality has always been that small molecules rather than biologics, dominate in development. For the first time in the last year, biologics have just about equalled the number of small molecules in the development pipeline,” he told C&I.
One of the differentiators for Ingenza is its ability to manufacture proteins using nine biological organisms, across bacteria, yeasts, fungi and mammalian cell-lines, Shott says.
“They’ve characterised them and understand them; many biotech companies have only one biomanufacturing host, constrained this in the target molecules it can effectively produce. [For a customer] Ingenza has the capability to select the ideal organism for the job, making the move to full scale as efficient as possible”.
Moving to the new building and adding GMP capabilities is an important step he said.
“Customers want the certainty that their service partners will support them through each stage of the development pipeline, and that processes are scalable and reproducible. We can support projects from the earliest stages of contract research and development all the way through to manufacturing” he said.
Shott is a serial life sciences entrepreneur, as co founder and executive chair of Arcinova, founder and CEO of Excelsyn and has held senior executive and board level roles at multinational organisations including AstraZeneca, Lonza and Rhodia. The Shott Scale Up Accelerator at the Royal Academy of Engineering, which he supports, has now provided over 300 entrepreneurs with business mentoring and leadership support.
Part of the challenge for science-based businesses is that many investors are more focused on businesses with short development cycles that can scale rapidly. That focus often totally excludes chemistry, biotechnology or engineering hardware businesses where the development cycles are much longer, he says.
Furthermore, while venture capital should have the ability to invest in companies that have no track record and a possible high upside, but a high chance of failure, this remains something the US tends to be better at than the UK, where there is more demand for existing revenues and order books - and certainty about those figures going forward.
His advice: “Make sure you have the right quality of leadership. Very quickly, you have to move from technology and technical focus to business, commercial customers and business development. Getting the leadership team right is critical, as is understanding how you can finance.”
One common problem faced by start-ups is that the founders are usually very technical and spend far too much time trying to perfect the technology in isolation, and then they are faced with funding challenges, he said.
“What they should be doing is getting into the market as early as possible and then find opportunities; the technology should be perfected for the opportunity, rather than in isolation. And while on that journey, look at how to get paid for doing it, so that you start to make money not just look for funding,” he said. “People tend to look at technical milestones rather than business milestones. Having a vision earlier of how some of that know-how could be valuable in someone else’s business is a good idea that’s difficult for people to understand.”
Nick Challoner, Ingenza’s CEO stressed the role of customers in the company’s evolution. “Putting customers at the centre of everything we do is of critical importance to being successful. We value the partnerships we develop and like to celebrate success with customers,” he said.
“Recently we had the pleasure of a visit by HRH The Princess Royal to officially open our new facility. Just a few weeks earlier, we were also honoured to host a visit from Scotland’s First Minister, John Swinney. In both visits we took the opportunity to involve key customers and collaborators who have contributed significantly to Ingenza over the years, but also to highlight the fantastic support received by our expansion partners – Pioneer Group FSE and Scottish Enterprise, without whom we would not have been able to deliver the key elements of our strategic growth ambitions.”
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