Pharmaceutical and biopharmaceutical manufacturing companies utilise highly complex processes which can present a variety of challenges, ranging from batch variability and failure, to low process yields and purity issues. These can have severe impacts on the effective supply of medicines to clinical trials or the end market.
Before they established APC in 2011, Dr Mark Barrett and Prof Brian Glennon had been actively working on reserach with the pharmaceutical industry in Ireland through the Science Foundation Ireland funded Solid State Pharmaceutical Centre at UCD's School of Chemical and Bioprocess Engineering. Their work there led them to establish APC to assist the industry in meeting these challenges.
APC develops, designs and markets proprietary engineering platform technologies that offer solutions to these problems. These technologies have been used in well over 100 different projects with some of the world’s leading pharmaceutical companies. “We are now working with eight of the world’s top 10 pharmaceutical companies and five of the top 10 biopharma companies,” says APC director of European operations Brian O’Sullivan.
The company has developed two engineering platform technologies, Achieve and BioAchieve, for troubleshooting research and manufacturing issues and improving the design of chemical and biopharmaceutical compounds.
“We support the industry in the development and manufacturing of new biological entities,” O’Sullivan explains. “We help them reduce costs, eliminate process failures, and mitigate risk to ensure that they can continuously supply their products to the market.”
This helps meet the pharmaceutical industry’s need to develop and supply their medicines in a cheaper quicker way. This focus by pharmaceutical companies on reducing the time to market for new medicines whilst cutting costs and maximising process understanding makes APC’s technology very attractive.
APC becomes involved after a new product has been developed and assists customers to optimise its production. “Companies come to us and transfer their process to us. We run it on our platforms and analyse it from start to finish to identify any problems. After that we design an optimal process which overcomes the difficulties and delivers the desired results.”
Previous innovation in this field concentrated in new chemistry-related solutions. APC’s technology concentrates on process engineering allowing it to be applied to every chemical biological compound that requires a process to supply that material.
Another highly innovative aspect of the APC solution is the fact that it combines computer modelling with actual lab work. “We model the process on the computer but this is supported by actual experimentation,” O’Sullivan points out. “Our lab here can run pharma and biopharma manufacturing processes on a small scale, from 10ml up to five litre batches. We use that to generate and create very specific types of data.”
This data is then integrated into the computer model in a unique combination of the real and digital worlds. And the technology is tailored to meet the specific needs of the two strands of modern medicine development and manufacturing. The Achieve platform is designed for the traditional small molecule pharmaceutical industry which is based on the chemical synthesis of compounds. BioAchieve meets the needs of the large molecule biopharma industry which is based on the use of cell cultures to produce the desired organic compounds.
Given the unique nature of the solutions it is not surprising that APC is doing very well commercially. “It’s very exciting”, says O’Sullivan. “The company was founded in November 2011 with just the two founders working for it. We now have 36 full-time employees working for us and we’re still growing. Our staff are all highly skilled people – 85 per cent are PhD qualified. We are already the largest employer of PhD qualified chemical engineers in Ireland. We are very proud of that.”
Another source of pride is the way the company has grown. “We think it’s very significant that our growth has been achieved completely independently,” O’Sullivan says. “We have had no external investment. Our growth has come about entirely as a result of market requirements. We are fortunate in that we are creating our own market as no one else does what we do. We opened a US office last year to support our growth in that market.”
And while the company numbers the world’s top players among its customers, its market is very broad. “We work with the top companies right down to companies with 10 or 20 people who are just bringing their first molecule to the market.”
Appropriately enough for a finalist in this year's Irish Times Innovation Awards O'Sullivan sees the company's future lying in continued innovation. "This is the core of APC. We are continuously looking at our platforms to see how we can improve them to deliver better solutions to our customers.
We will invest around €1.2 million this year in internal R&D activities. We are supported in this activity by Enterprise Ireland and their assistance has been very valuable to us."
The company may also find itself involved in small scale manufacturing on behalf of customers in the future. “At present a company comes to us with a process. We evaluate the process and design an improved one. We deliver that new process back to the client who implements it. In the future we may find ourselves working on the implementation or moving into small scale manufacture on behalf of certain customers. For example, where the product is only required in small amounts for clinical trials we could do that for them here in Ireland.”
“We are delighted that APC is recognised for innovation,” says APC co-founder Dr Mark Barrett. “It has been an incredibly exciting journey for our team to conceptualise, develop and commercialise new innovative pharmaceutical engineering technologies.”