As a company, we work with more than 50 of the world’s largest Global Multinational BioPharma & Pharma companies and innovative Biotech companies with a mission to accelerate the development of life-changing medicines for our clients and their patients.

For this case study, we are working with a Global Multinational Pharmaceutical client company who came to us with a significant problem for them but a common problem we hear from many companies.

The challenge

Their challenge is that one of their CDMO’s produce their API for the product for them, but the quality profile has changed over the last couple of years leading to issues with the Final Drug Product quality. The primary person in this company’s team who is looking after the product is not an organic chemist so doesn't know the right questions to ask or the right places to look at the CDMO.

They have the product history in the documents and not in people’s heads but if they don't know where it is located in these documents then they won't know where or how to look for it. The team have been struggling in pulling everything together to define the optimal process - they need a more holistic view taking CpK and PpK data and that should come together with the development work tech.

Because of this problem, they have now a consistent issue with the quality of the final drug product, leading to significant issues with the ability to manufacture & release consistently and ultimately issues in relation to the supply of this medicine for their patients.

Our Solution

We offered to use our new iAchieve Activate & Answers AI tool, which is our proprietary iAchieve platform with AI embedded to take on this challenge. identify process risks and gaps.

Our iAchieve Activate & Answers AI tool ingested hundreds of product development reports, CDMO manufacturing campaign reports, product & process validation reports, P&ID's of the manufacturing facility & equipment, production deviation reports/CAPAs & Change Controls and previous process data (such as PpK data and other product quality data & trends).

They also felt that there may be some underlying process & analytical issues and that we could use our iAchieve Activate & Answers AI tool to identify which steps or which methods were the likely problem areas.

Also, they highlighted that their regulated starting material that has a very long lead time, which they believed was due to the complexity of the manufacturing process (taking up to 18 months to produce) and they felt that our iAchieve Activate & Answers AI tool could help them evaluating if there is any way that this could be made more efficient i.e. to shorten this total lead time and as a result, support planning for new batch of this material.

Finally, they wanted us to take the existing legacy development reports (>200 pages in length) and use our iAchieve Activate & Answers AI tool to condense into a 3 or 4 slide summary for communication to executive members and other non-technical stakeholder, in a non-detailed technical science but instead to focus on this is the risks & mitigations.

The Outcome

As the service we provided is for a client of ours, we cannot share the outcome due to client confidentiality. But overall outcome was exactly what they needed.

The iAchieve Activate & Answers AI tool is totally transferable capability. We have spoken to companies in the clinical trials, medical device, food manufacturing sectors but the concept could be applied to many other sectors beyond these sectors.

What are the next steps for your firm with your AI journey?

We are continuing to test the market, running a number of pilots projects with companies to ensure we understand our product-market fit. We are also advancing our AI capabilities internally and building a team to support this growth so that we can continue to be leaders in this space.

Where do you think business or your sector needs more support from national and/or EU policy makers to adopt and/or innovate with AI?

A clear AI national / EU wide policy, supported by Government led funding, is essential to enable SME’s in particular to develop their roadmaps & execute at the pace which we need to in Ireland. Supporting Irish / European companies to create this competency is critical to give us independence from Geopolitical challenges & risks. As a country and in the Biopharma sector, we have been behind the curve in relation to global digita leadership and if we want to deliver on an ambition to be leaders in innovation again, we need to begin moving at pace.