Compliance: Framing Success Utilizing PIC/S and EU GMP

November 21, 2023 || LeAnna Pearson
Introduction PIC/S was founded in 1995 as an extension of PIC  (Pharmaceutical Inspection Convention).  They are a non-binding cooperative arrangement between 56 different Regulatory Authorities.  Just seeing the number 56 does not have the same impact as seeing the map below and understanding the true global reach of PIC/S.  Their…

Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline

November 20, 2023 || Rosario Hughes-Kielty
To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality Risk Management (QRM) principles have emerged as a key strategy in achieving this goal. QRM details a comprehensive evaluation of risks associated with both patient…

Solving Drug Shortages With AI

November 10, 2023 || Nick Armstrong
Explore the positive impact of artificial intelligence (AI) on pharmaceutical manufacturing, addressing persistent drug shortages. Dive into the benefits of predictive analytics, quality control enhancements, and supply chain optimization. However, as we unlock the potential of AI, we acknowledge and tackle concerns like data quality, fairness, and regulatory compliance for responsible implementation. Join us in revolutionizing drug manufacturing and ensuring reliable access to essential medications through the transformative power of AI.

Revolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections

November 10, 2023 || Connie Leech and Geraldine Carr-Mulry
COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. Whilst certain aspects of the pandemic have gone away, drug shortages have persisted on a global scale. The demand for flexibility in the supply chain remains imperative, However, many drug manufacturers are still reluctant…

The Pollinator-Friendly Data Centre Industry In Ireland That Is Helping To Save The Bees.

November 3, 2023 || Tom O'Farrell, Director of Client Engagement, Europe - Data Centre Services
“The bee is more honoured than other animals, not because she labours, but because she labours for others.” – St. John Chrysostom There appears to be constant negative attention towards Data Centres from the media in Ireland. Since the benefits of Data Centres are not reported fairly, then It shouldn’t…

Overcoming Commissioning Challenges to Achieve Operational Readiness

October 13, 2023 || Trent Vaden
As the data center market continues to grow exponentially, 3rd party testing and commissioning becomes vital to achieving Operational Readiness on time and in budget. Early engagement is a key component to overcoming the challenges to successful data center startup, due to the complexity and critical nature of the systems…

Revolutionizing Drug Development: The Role of AI in Protein Folding and its Impact on the ATMP Industry

September 29, 2023 || Robert Ossig
Protein Folding BackgroundIn the realm of drug development, the intricacies of protein folding have long posed a significant challenge. The way a protein folds directly impacts its function, and any misfolding can lead to diseases like Alzheimer’s, Parkinson’s, and cystic fibrosis. Additionally, the field of Advanced Therapy Medicinal Products (ATMPs)…

The Knowledge Transfer Stage of Technology Transfer

September 29, 2023 || Robert Ossig
Knowledge Transfer: The Crucial Stage of Successful Tech Transfer Technology transfer (TT) is a pivotal process in the lifecycle of any product, ensuring the smooth transition of knowledge, systems, and processes from a source unit (SU) to a receiving unit (RU). The Knowledge Transfer (KT) stage, which aligns with both…

Achieving Operational Excellence in Pharmaceutical Manufacturing through Program Management

September 29, 2023 || Erik Adams
In the fast-paced and highly regulated world of Biotech and Pharma manufacturing and operations, achieving Operational Excellence is paramount. It requires streamlined processes, efficient resource utilization, and adherence to strict quality standards. This is where a skilled Program Manager becomes an invaluable asset. With their expertise in orchestrating complex projects…