23 April 2024 Seminars

The presentation will cover the remediation of a global supply chain and its QMS to restart supply of critical and life saving medicines and the need for senior leadership support to achieve the safe flow of medicine after unfavourable inspections and failures of the local and global quality systems.
This will include overviews of remediating qms systems such as APQRs, deviations, batch back logs, versatility in training new staff and QPS, support and leadership, interactions with competent authorities and how some of the war stories were resolved and could be improved if faced again.

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.

Microfluidic chips have revolutionized the manufacturing of lipid nanoparticles and the development of novel drug delivery systems. The use of microfluidic devices offers great advantages in the optimization of lipid nanoparticles with decreased experimental times, complex flows, excellent mixing and high reproducibility. Our studies have demonstrated the continuous manufacturing of lipid nanoparticles varying from conventional to Stealth nanoparticles for passive and active targeting of cancer tumours or exosome-like delivery systems.
Our 3D printed microfluidic chips are designed for easy to scale-up production of nanoparticles with a variety of inner structures for efficient mixing of aqueous and organic flows at various ratios and flow rates. Advanced designs can be used for in situ formation of lipid nanoparticles that can be used directly for patient administration.

The new Annex 1 is the ‘hottest’ regulatory topic currently. The recently introduced standard for sterile medicinal products significantly raises the regulatory requirements in a number of areas.
This presentation identifies those areas where Industry routinely failed to comply with the previous Annex 1 and looks ahead to predict the potential compliance ‘pitfalls’ within the revised guidance and how to avoid these.

This session offers a chance to consider sterile and cleanroom compliance from the perspective of a former MHRA steriles accredited inspector, before most companies will have been inspected against the new Annex 1.

A draft guidance of Computer Software Assurance (CSA) for Production and Quality System Software has been recently issued by the FDA. This new guidance, together with the second edition of the GAMP 5 guide, have shifted the emphasis away from indiscriminate scripted testing and documentation, towards more critical thinking and a risk based testing strategy. But CSA goes beyond the deployment of a particular methodology for testing strategy. It is more about a way of thinking about the management of computerized system, moving further towards a risk-based approach in all the aspects of their management.
Now that the new recommendations have been established, this practical session will cover the steps companies should take to align themselves optimally with the new CSA approach and take advantage of the opportunity to improve their software implementation and validation processes, spending less time on the mechanical aspects and getting better results.

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

Engineers have a key role in ensuring products, systems and processes meet quality requirements by being the ultimate problem-solvers… preventing problems before they happen! This talk will explore the role of engineers in quality risk management throughout the product lifecycle.

The talk will explore: Rising Global Temperatures and Future heatwaves; Some impacts including safety, performance and productivity; and adapting industry to cope.

Often we are given procedures to follow with no involvement in the content, how they are written and even if they make any sense to us. In this lively presentation we will cover the importance of involving the end-user in the design and wording of procedures, so that they are written in a style, language and way that the end-user understands. We will also cover how to check if a new procedure reflects reality, as sometimes they require actions that, in reality, cannot always be done that specific way.

This presentation describes how UV dissolution imaging is being used to provide insights and mitigate against failure in its use in the determination of intrinsic dissolution rates and drug release from whole dosage forms. Several case studies reviewing the effects of various excipients in controlled release systems, solid dispersions, cocrystal systems and hot-melt extrusions formulations will be discussed.  Applications of UV imaging to non-oral formulations have started to emerge and will also be discussed.

This presentation will be of interest to excipient companies, and pharmaceutical companies working in the pre-formulation and formulation sectors.

Twitter: @dr_kasareaddo

Research group twitter: @AsareAddo_RG

Do you have responsibility for the oversight of outsourced manufacture of Investigational Medicinal Products (IMP)?

This talk will introduce basic processes that support the qualification of contract manufacturers in your GMP supply chain. It will demonstrate sponsor oversight for effective management of risks associated with the manufacture of IMPs. Anonymised events at manufacturing sites that benefited from sponsor feedback by documented risk assessment will be given.

Start as you mean to go on. Make sound risk-based decisions when selecting vendors, confirming their GMP manufacturing process, and assessing events that occur during manufacturing by using a simple pragmatic quality system.

Amorphous Solid Dispersions remain an important approach to addressing the poor solubility of new drug molecules. Although there has been much work in the area, there are key challenges that remain? How do we optimise selection of

formulation and process using low quantities of drug, whilst minimising the risk of drug product failure. In this session we will explore the resurgence of ASDs as a formulation strategy and discuss through a diverse range of exciting presentations, the advances in our fundamental understanding of the topic. We are particularly interested in examining this topic through a materials science lens and how that is helping to provide a deep understanding of these drug delivery systems and paving the way for exciting new drug products.