PDA Ireland Chapter

Thank you for connecting with the PDA Ireland Chapter.

The mission of PDA is to promote the exchange of rapidly evolving information on the latest technology and regulations.

As a registered non-profit affiliate of PDA International, PDA Ireland aims to deliver on this mission by:

• Providing events and processes to facilitate the sharing of best practices, technologies, and regulations to meet the tactical and strategic needs of you, our members.
• Facilitating collaboration with regulators and other representative bodies to achieve alignment and cohesiveness across the industry.
• Providing a great networking opportunity for you, our members, to connect with like-minded professionals, subject matter experts, and regulators.
• Serving as a networking forum for manufacturers, young professionals, academia, and service providers engaged in the pharmaceutical/ biopharmaceutical industry in Ireland.

Our activities are delivered voluntarily. Our success depends on the willingness of our volunteers to share experiences, plan and organise events, engage in PDA interest groups, or contribute to future technical reports.

Continuing to build our membership is key to enabling us to achieve our goals. We all face similar opportunities and challenges in our professional lives; our chapter network can strengthen our ability to face these with confidence.

Aidan Harrington
President, PDA Ireland Chapter

PDA Ireland & PDA UK - Brexit, September 23, 2022

PDA Ireland ATMP Event, November 26, 2021

PDA Early Careers Event Career Progression in Ireland’s Pharma Industry, October 14, 2021

PDA Ireland ATMP Event, November 26, 2021

2020 Positive Learnings and 2021 Predictions

A Discussion with PDA Ireland Chapter President, Ann McGee
February 18, 2021

Data Integrity in Dublin, June 23, 2022

A Discussion with PDA Ireland Chapter President, Ann McGee
February 18, 2021

Data Integrity in Dublin, June 23, 2022

A Discussion with PDA Ireland Chapter President, Ann McGee
February 18, 2021

Chapter News

ATMP Hybrid Event Highlights, November 26, 2021

Matt Moran was very optimistic for Irelands future, advising the audience that the Ireland Pharma Industry exports over €100 billion annually and that ATMPS will be a significant growth area for Ireland in the Pharma sector.

The outlook for Ireland is very promising with the work of the CGT&V forum, NIBRT, and companies such as Takeda, Biomarin, Pfizer, Eli Lilly, Janssen, Merck, Astellas, MEIRAGTx; amongst many others.

Prof. Niall Barron gave an overview of the excellent strategic work being carried out in Ireland by the CGT&V forum, and encouraged the delegates to engage with and join the forum.

Bertie Takeda Grange Castle, Dublin, is the first approved stem cell manufacturing facility in Ireland. Drug Product production scheduled to start January 2022. Isolation technology will be used for manufacturing in the planned facility expansion.

Brian O’Connor, gave a fascinating presentation on the work of MEIRAGTx, who are developing a Deep Pipeline of Transformative Gene Therapies. The new MEIRAGTx cGMP 150,000 sq ft facility in Shannon will be used for Flexible and Scalable GMP Manufacturing for Clinical & Commercial Production.

Warren Roche gave a master class mathematical presentation on the Advanced Kinetic Degradation and Thermodynamic Modelling in Biopharmaceuticals, maths can indeed be enjoyable to listen too!

Dr. Aidan Harrington and Kate Coleman shared their extensive expertise of the ATMP regulatory environment, including some challenges,

• Skills shortages in sterility assurance and microbiology
• CDMO capacity to support ATMP manufacture.
• Human behaviour needs to be carefully considered in the contamination control strategy. Humans are not robots and behaviours change over time.
• Consider using GMP raw materials in development phases to ensure product consistency in all stages of product life cycle from development to commercialisation.
• Sometimes it is difficult to define what part of the ATMP is actually the API. End point indicators may not be available for some ATMPS.

Dr. Catherine Jomary shared lessons learned from over 25 years working in the ATMP sector for several Biopharma companies.

Catherine mentioned that single use technology platforms are available on the market to address the challenges of scale-up including the significant process development at both R&D and commercial scale is required for ATMPs

Garry McAuslan gave an intriguing insight into Bringing Pharma Proximal to Hospital Cancer Centres of Excellence and Fully Automated Digitised Cell Therapy ‘Future Factories’.

Dr. Christian K. Schneider, gave of the role of global regulatory agencies and how they are here to help/support the industry in the growth of the ATMP sector.

David O’Loughlin Shares PDA Europe Annual Experience

Earlier this year, I was honoured to be one of two students awarded a bursary to attend the 4th PDA Europe Annual meeting in the beautiful city of Amsterdam. The theme of this year's conference was "Global Healthcare of the Present and the Future." Having just finished my third year on the BSc in Pharmaceutical and Biomedical Chemistry at Maynooth University, I was keen to see how technology is advancing in an increasingly digital and paperless age.

On the first day, I met the members of the Irish PDA chapter and had an opportunity to see the many stalls from exhibitors.

One of the sessions I especially enjoyed was Derek Duncan's talk on "Ensuring Container Closure Integrity of Gene Therapy Products Needing Deep Cold Storage" Dr. Duncan was from LIGHTHOUSE Instruments who design and develop non-destructive analysis equipment for determining the gas composition of the headspace. Their instruments can determine if CO2 has leached into gene therapy vials during storage on dry ice. CO2 ingress shows that during storage, the vial has been compromised, which could lead to contamination of the product.

The highlight of the conference for me was Jose Castillo's talk on "Low-footprint, Intensified, Single Use Platform for the Production of Viral Vaccines. The team in Univercells have developed 'NevoLine,' a viral vaccine production technology that cuts the footprint of a facility from 5000-10,000m2 to 1500m2 and they estimate the cost per dose will fall from US$1.2-1.5 to US$0.3. In a world facing into a shortage of vaccines with a supply gap for IPV of around 50 million doses/year, any system which can reduce the footprint required to develop these vaccines is extremely valuable.

Other sessions were highlighting the potential for new technology, including one on the implementation of BlockChain technology into the pharmaceutical industry. It was fantastic to get exposure to regulation in the industry. We had been told about the importance of regulation but had no first-hand experience of it. So I found the keynote speeches from the FDA, EMA, MHRA and WHO especially interesting.

I want to thank the PDA Ireland chapter for this wonderful opportunity, and I hope to stay involved with them in the future.

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