MP-A Seminars

9:30 am - 9:50 am

Decision Making for Process and Product Sustainability in an Uncertain World

Rational, transparent decision-making is vital for effective innovation management in the manufacturing process industries. Those prioritising projects and/or technological options on sustainability grounds early in the R&D cycle however face a twin challenge: holistic decisions must incorporate complex success criteria but there is invariably a substantial degree of uncertainty about the evaluation. We present both a practical framework for early-stage sustainability assessment amongst a set of alternatives and an improved method of multiple-criteria decision analysis, CURE (Computed Uncertainty Range Evaluations), illustrating through case study how they may be readily implemented to support a facilitated decision-making process in the pharmaceutical industry.

Speaker

9:50 am - 10:10 am

Helium Crisis?

Presentation based on this published Blog:

Helium crisis revisited

Are we on the cusp of a helium crisis? There are many examples of scientists predicting that global helium reserves will be depleted in 20 to 35 years but we don’t believe this is credible. The Mineral Commodities Summaries 2023, produced by the US Geological Survey, part of the US Department of the Interior, reports that global reserves of helium total 39,850,700 million cubic metres. The Geological Survey has very detailed accounts of reserves and production, but it does not give consumption figures. If we assume consumption is equivalent to the production of 160,000 million cubic metres, then reserves for 249 years are calculated [4]. Based on 2019 data [1], supplies are adequate for an estimated 335 years,

The largest terrestrial helium reserves are in the US. In 2022, the US was responsible for 46.9% of global production4. About 75% of this helium is extracted from natural gas of the Panhandle-Hugoton field, which straddles Texas, Oklahoma and Kansas. This natural gas is helium-rich, with an average concentration of 0.586% [2]. Helium has been found in concentrations as high as 8% in some global sources of natural gas. In the US, the lowest practical helium concentration that can economically justify extraction is about 0.3% [3]. Qatar is the second-largest producer, with 37.5% of global production in 2022. The US and Qatar together accounted for 84.4% of world production in 2022, followed by Algeria (5.6%), Russia (3.1%) and Australia (2.5%) [4].

According to many sources, we are still being affected by a helium shortage that began in 2019 as a result of the prolonged closure of the world’s largest purification facility in the US and critical maintenance at another two of the world’s eighth-largest purification plants. This became more pronounced in 2021 and 2022. The price of helium saw an increase of 300% between 2000 and 2020.

References
1. LCGC blog, 11/4/22. https://www.chromatographyonline.com/view/not-another-helium-crisis-
2. Brown, A (2019). Origin of Helium and Nitrogen in the Panhandle-Hugoton Field of Texas, Oklahoma and Kansas, US. AAPG Bull. 103 (2), 369–403. doi:10.1306/07111817343
3. National Academies of Sciences, Engineering and Medicine (2000). The Impact of Selling the Federal Helium Reserve. Washington, DC: The National Academies Press. https://doi.org/10.17226/9860
4. Mineral Commodities Summaries 2023, US Geological Survey, US Department of the Interior. https://pubs.usgs.gov/periodicals/mcs2023/mcs2023.pdf

Speaker

  • Frank Judge Consultant Chemist - Chromatography - Butterworth Laboratories Ltd
11:30 am - 12:30 pm

KEYNOTE: Emerging Technologies Transforming and Reshaping Sustainability in Pharmaceutical Manufacturing

Speaker

2:00 pm - 3:00 pm

KEYNOTE: Risk Mitigation of API Supply, Shortages Analysis

Speaker

3:45 pm - 4:15 pm

Sustainability: A Way of Life in Our Industry?

Speaker

4:15 pm - 4:45 pm

Driving Sustainability in a Clinical Research Organisation

Speaker

9:15 am - 9:35 am

Becoming a QP – The VIVA is Just the Beginning

Speaker

  • Damian Larrington Pharmaceutical Quality Professionals - Pharmaceutical Quality Professionals
9:35 am - 9:55 am

Navigating the Path to Success: Professional Development for Growth, Progression and Succession

In today's dynamic and competitive business landscape, professional development has become an essential cornerstone for individual and organisational success. This presentation, titled "Navigating the Path to Success: Professional Development for Growth, Progression, and Succession," delves into the critical strategies and practices required to ensure personal and organizational growth, progression, and smooth succession planning.

Speakers

9:55 am - 10:15 am

Changing the Quality Culture of a Business

Changing the quality culture of a business

"The pessimist complains about the wind. The optimist expects it to change. The leader adjusts the sails."
Identifying the common areas businesses struggle to get engagement
• Input into quality events
• Reviewing and understanding SOPs
• Incorporating Quality into decision making
Finding solutions to improve engagement
• Showing how Quality can make their roles easier i.e. can aid them implementing a change by interdepartmental collaboration
• Effective training so the purpose of an SOP is understood – it is a document to help processes and are always a working progress
• Demonstrating the impact engaging with quality events can have on the processes, they can be part of the solutions to bring the company forward

Speaker

11:30 am - 12:30 pm

KEYNOTE: Artificial Intelligence in a G x P Environment and its Impact on You – How to Stay Relevant in the AI World

Speaker

12:15 pm - 1:15 pm

KEYNOTE: Process Modelling Advancement in Drug Product Development

Digital manufacturing and process modelling approaches are gaining significance in drug product development. In this talk, an overview of process modelling approaches will be given and its application in a real industrial case study will be discussed. The application of process modelling tools to increase process understanding and process scale up to facilitate technology transfer and life cycle management is in increasing demand. Validation of process models using industrial real life data for roller compaction process will discussed in detail during this presentation.

Speakers

2:15 pm - 2:35 pm

Safety Considerations in Manufacturing Pharmaceuticals

Speaker

2:35 pm - 2:55 pm

Quality by Design for Projects and Processes

Speaker

  • Richard Coe GDP Responsible Person - Protogen Consulting
2:55 pm - 3:15 pm

Manage Industrial Assets in Pharmaceutical Manufacturing

Speaker

  • Zhiru Tang Platforms Engineering Manager, Biologics & Devices Manufacturing - GSK