PDA Ireland Chapter

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.

Rebecca Kelly Shares PDA Europe Annual Experience

I was honoured to be present at the 2019 PDA Europe meeting which took place on the 25th and 26th of June in Amsterdam. Below is a summary of my experience at the event. The first day of the conference began with a regulatory update consisting of information on the most recent changes in the pharmaceutical industry especially in relation to developments regarding the EMA, the FDA, the WHO, and PIC/S. For the remainder of day one and the majority of day two, the event was split into three parallel tracks with different topics at the centre of each track. The options had a wide variety and included discussions on Virtual Reality, Manufacturing Technologies, Robotics in Pharma, Implementing Technologies, Blockchain Technology, Decontamination, Sterilization Technologies, Artificial Intelligence in Pharma, Young Professionals in PDA and Personalised and Precision Medicine. As a biotechnology student, I was immediately drawn to Robotics in Pharma. I also attended the Virtual Reality and Artificial Intelligence presentations as I believe this will be the future of biotech and Pharma industries, and I am keen to gain additional knowledge on these topics. Throughout the Virtual reality presentations, the speakers conveyed how industries need to update training methods to keep up with evolving technologies. I learned that this is already being applied in the form of E-learning, but more recently, a concept called 'Deep Training' has come into use with the help of virtual reality. This type of training could be used to train manufacturing associates in a controlled manner as there would be no risk of losing product due to simple errors. The trainees would wear virtual reality goggles and carry out tasks in an area that is set up similar to a clean room. The equipment would also monitor the speed at which the user operates at; this has the potential to be very useful as it would make the user more informed and conscious about how many particles they are creating when they are moving in the cleanroom. This option also makes it possible to simulate situations that would rarely happen in the real cleanroom leading to operators being more prepared and confident in challenging situations. I enjoyed this section of the event as it shows how training will become more exciting and encourage more involvement. The speaker displayed how effective this technique is by giving us the following statistics related to different methods of training:

Next, I attended the Robotics in Pharma talk. During this presentation, we were shown a real example of a robot that could be used in many industries in the future. It could recognise obstacles in its path and re-divert in a safe way to avoid them. The speakers talked about how robotics could eventually take over specific important roles that humans currently play in the industry. As humans create up to 80 percent of contamination in clean rooms, this could be revolutionary. As well as carrying out tasks effectively and efficiently, the robots would free up time for workers to carry out other activities. The final presentations I attended were those on Artificial Intelligence in Pharma. An interesting point that was made in this section was that 'Artificial Intelligence is not always correct, but it is less incorrect than humans.' I found it hard to believe that computer systems could perform tasks that previously required human input, but I now know this is the direction many businesses will be moving towards as there are many benefits to this type of technology. An example of where this could be used in industry is in the visual inspection process. This is a time-consuming task which requires complete concentration from the inspector, so I can see the benefits of this being carried out by a computer system. Apart from the tracks, there were also exhibitions at each break where the newest technologies, methods, and equipment were displayed and explained in great detail.

The PDA conference has opened my eyes to all the new possibilities which are being developed all over the world at this moment. No doubt, in a few years, the technologies mentioned above will be taking over operations in industry and making workplaces more efficient and productive. It was a privilege to listen to each of the speakers as they shared an abundance of valuable knowledge surrounding the most recent introductions and changes to the world of medicine, science, and healthcare. I am so grateful to PDA Ireland for providing me with this fantastic opportunity, and I would like to say a special thank you to all of the Irish delegates who made me feel so welcome to the event and also those who helped to organise the trip. It was so enjoyable, and I loved every second of the beautiful Amsterdam!

PDA Ireland sponsors the Salters' Festival of Chemistry – hosted by Trinity College, May 18, 2019

PDA Ireland made a charity donation to Barretstown - the official charity partner for 2019

Biocidal Products Regulation – ‘cleaning’ up the marketplace

Author: John Chewins, BSc, MBS Director, Scientific and Regulatory Affairs, Bioquell UK Ltd.

This article is your guide that provides important insights into the new regulations covering bio-decontamination claims and processes in Europe.

PDA Ireland is delighted to announce 2020 Student Bursaries:

• PDA Ireland, with support from PDA Europe are offering 3 scholarships to Third Level Students (undergraduate and postgraduate), to attend the PDA Quality and Regulations Conference, on 9th & 10th June 2020, in Dublin (https://www.pda.org/global-event-calendar/event-detail/quality-and-regulations-conference). 

• The bursary will include a free ticket to the event, hotel accommodation and €100 towards travel expenses. Post the event the students must write a short article about their personal experiences at the conference which will be published on the PDA website and the PDA letter.

• To apply for one of these bursaries, you should write a short outline (NMT 500 words) of why you would like to attend the annual meeting, and what you would hope to gain from it. Please submit your application to [email protected]. The closing date for receipt of applications is 20th April 2020.

2019 PDA Ireland Bursary Winners

In partnership with PDA Europe, we have continued our commitment to provide educational development opportunities for students by producing our 3rd Bursary.

This year, we accepted applications to third level students (undergraduate and postgraduate). The bursary included a free ticket to the PDA EU Annual Meeting on 25 - 26 June 2019 I in Amsterdam, The Netherlands and €800.00 towards travel expenses and accommodations..

We are proud to announce the names of our 2019 Bursary recipients: Rebecca Kelly and David O'Loughlin.

Rebecca Kelly

Rebecca Kelly is twenty years of age from a town called Glenamaddy in Galway, Ireland. She is currently undergoing her third year of study in Biotechnology at the National University of Ireland, Galway. At this time, Rebecca is interning at Alexion Athlone.

Rebecca learned about this opportunity on the PDA Ireland Chapter's LinkedIn page.

She is interested in the industry placement session and desires to learn more about this topic during the PDA Europe (PDA EU) Annual Conference.

David O'Loughlin 

David O'Loughlin is currently completing his third year BSc in Pharmaceutical and Biomedical Chemistry at Maynooth University. In July, he will begin the Human Toxicology student placement programme at The State Laboratory in Kildare, Ireland. David's interests include toxicity, glycobiology, and personalised medicines.

David learned about the bursary from his University's Placement Office, who posted the flyer on the student forum. "I applied because I wanted to take the opportunity to get a feel for the developing world of Pharmaceuticals and to see how some of our in-class material refers to the real world."

He is interested in several sessions at the upcoming (PDA EU) Annual conference as they may assist him in exploring future Ph.D. opportunities.

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