Industry Insights with… Paul Quigley
To coincide with CPhI North America 2019, we asked our Head of Drug Substance, Paul Quigley, to share his thoughts on the changing CDMO sector. The latest blog in our Industry Insights series highlights the importance of flexibility and integration for accelerated drug substance and drug product development.
With the pharmaceutical industry facing greater challenges as drug compounds become increasingly complex, how are CDMOs adapting to this new environment?
CDMOs are increasingly taking the place of internal pharmaceutical manufacturing operations in order to expedite the delivery of new drug substances and drug products. They are able to apply their breadth of experience from working with different clients on a diverse range of projects. This greater level of knowledge and expertise provides an advantage for successful drug development. CDMOs fill a gap where pharma companies may want to outsource, and enable biotech companies to completely externalise development.
Why is integration key to accelerated drug development?
Integration, and the greater speed it can achieve, is especially important from a biotech perspective. The biotech business model requires fast advancement though each phase of development to receive milestone payments. Rapid delivery is therefore vital and accelerated development can be achieved by outsourcing projects to an integrated delivery system. Arcinova offer all project components on one site, which ensures greater speed and satisfies the requirements of our biotech clients.
How do you ensure greater speed and scalability during drug development?
It is vital that CDMOs have a comprehensive project management framework that covers all of the different elements of drug substance, drug product, radiolabelled drug substance and bioanalytical analysis. This should be complimented by a coherent set of metrics and IT systems that are used to measure project delivery. Arcinova has the natural advantage of a one-site structure where all of our capabilities are offered from one facility. We can resolve issues very quickly, in comparison to CDMOs that are geographically separated.
Which technological innovations are aiding the acceleration of drug development?
AI and other digital technologies are incredibly important for improving the velocity of delivery in the pharmaceutical industry. Data analytics are also being used to provide process definitions, which will help improve process scalability and the speed of delivery. For drug substance, we are exploring a number of innovations, including the use of flow technology to reduce reaction stages. We have a recent example where an eight-stage process was drastically shortened by compressing three of the eight stages into one. The employment of flow chemistry enabled months to be taken out of the delivery programme and the significant improvement of process economics. Arcinova is also exploring the use of synthetic biology to substantially shorten the number of process stages and simplify the overall drug substance manufacturing process.
Please can you define the Arcinova model for successful drug development?
The Arcinova model is based on the fact that we are a single-site operation, providing the flexibility and agility to deliver outstanding drug development. We aim to grow organically by developing the existing culture within the company and building on the long-standing skills and knowledge of our staff. Our 30 years’ operating experience enables us to supply big Pharma capacity but with the flexibility to make decisions rapidly. If a client needs new technology to be implemented or their requirements change, we can respond very quickly as a company. Our fully integrated site and strong project management capabilities allows us to swiftly refine client deliverables and timelines.
How are patients benefiting from this new, integrated approach to drug development?
Patients are benefiting from the greater ability to produce drug substance of high purity for clinical trials. The recent high-profile recall of drug products due to contamination has emphasised the importance of strong analytical discipline in pharmaceutical development. An integrated approach to drug development can ensure low level impurities, particularly through the employment of on-site analytical teams. At Arcinova, we are putting in place state-of-the-art technologies, innovative site capability and the analytical discipline required to ensure the quality of all products that we generate and ship out are of the highest standard.
How do you see the industry’s needs changing in the near future?
The industry is moving towards small molecule drugs that are increasingly complex and potent. This is allied to the advent of patient-specific medicine and the production of pharmaceutical products in smaller volumes. The combination of greater complexity and small batch manufacture plays to the strengths of modern CDMOs that have the capability to deliver complex compounds and remain a secure source of delivery.
If you would like to learn more about the work of our drug substance development team, please get in touch here