MP-D Seminars

With the growth of computerized systems and automation being used throughout the healthcare manufacturing process, Manufacturing Executions System (MES) Technology has been introduced to the work Process.
The technology has spawned the use of electronic record creation of the production record entries.
"Desired State" - goal as described in FDA risk-based approach guidance.

Timely e-records production and access mitigate the risk.
Continuous "real time" Quality Assurance (24x7).
(CPP) Critical Process Parameter data recorded and correlated to product quality characteristics - how process factors impact performance or product.
Tools such as statistical process control and ad-hoc reporting to facilitate better scientific process understanding and provide the basis for PAT (Process Analytical Tec

Many organisations approach Data Integrity auditing with a very narrow focus on audit trail review of laboratory equipment.

While this is an important element there are many other areas which should be audited to ensure the "auditee" organisation has built an holistic data integrity approach into their Data Governance System, that incorporates and internal and external perspective with suppliers.

The Annex 1 revision comes into force on August 25th, 2023 (with the exception of section 8.123). With 4 months to go until the implementation date, Phil Rose from NSF will look at the what has changed in the revision and what has not. He will detail what the changes in Annex 1 actually mean for companies and, perhaps most importantly, discuss some of the most frequent questions that he has received from companies on the Annex 1 revision. This expert presentation will provide insights and 'real life' issues impacting the pharma industry as it gets ready for August 25th.

ChemoSeed is a cylindrical, biodegradable drug eluting seed for the administration of chemotherapy directly into the resection margin of high-grade gliomas and is designed to deliver the chemotherapy for greater than 7 days.  The release is diffusion controlled, with the biodegradable polymer degrading at between 3- and 6-months post implantation when the chemotherapy is exhausted.  It provided localised delivery of a high local dose avoiding systemic toxicity, reducing side effects with no impact on wound healing.  The diameter of ChemoSeed allows for ease of administration using a 12-gauge biopsy needle or catheter, which adds minimal time (< 40 minutes) to current resection surgery procedures.  Between 15 and 60 seeds could be implanted into the brain parenchyma/ resection margin and a rate of 30 seconds per seed. ChenoSeed has been included onto the Tess Jowell BRAIN MATRIX clinical trial as a Phase II study.  This talk will take you through the development of ChemoSeed, from tissue culture and drug release studies to preclinical testing, demonstrating an accelerated development pathway that will see translation from concept to patient benefit within 5 years.

The UK top 10 R&D investing companies (which have some subsidiaries around the world) invested €17.4 billion in pharmaceutical manufacturing, and the top two UK-based firms belong to the pharmaceuticals sector, with GSK and AstraZeneca respectively ranking 29 and 31 worldwide in 2020. In March 2020, the UK government committed to the creation of the Advanced Research and Invention Agency (ARIA) which is an independent research body to fund high-risk, high-reward scientific research. Besides, data analytics, digital tools and digital transformation can help to establish collaborations with external stakeholders (including patients, academia, non-governmental organisations and industry) and with international regulatory authorities on ‘Big Data’ initiatives. Thanks to such digital technologies, data can be managed and analysed within a secure and ethical governance framework. However, it is necessary to understand the latest advancements and problems when utilising enhanced data analytics for pharmaceutical safety and authenticity in order to optimise the system operation and consumer trust. Enhanced data analytics methods and their current applications in the UK pharmaceutical industry should be evaluated to establish an initial approachable framework. There are a variety of international and national regulations about data sharing and collaboration in pharmaceutical sectors, particularly about safety and authenticity. Although many data analyses can be used to support and maintain the interests and trust in UK’s consumers, it is hard to monitor the effective the translation into good practices due to different concerns. Therefore, the project focuses on relevant regulations-standards related to the pharmaceutical supply chain with the support of data analytics, and case studies of opportunities and challenges before offering potential suggestions.

3D printing technologies have been recognised as having significant potential for on-demand manufacturing of personalised medicine due to their advantage of accurately controlling the microstructure of solid dosage forms. One of the most researched and published thermal-based 3D printing method is fused deposition modelling (FDM). However, there are significant formulation limitations with FDM as most pharmaceutical grade polymers cannot be directly used to form printable filaments, and the addition of excipients such as plasticisers are necessary to enable printing. These additives used to tune the mechanical properties of the filaments can often have undesired effects on drug release. This talk will discuss the development of the first direct granule fed 3D printing of pharmaceutical solid dosage forms with high precision to print solid and porous structures. The printing used in this study, Arburg Plastic Freeforming (APF), thermally processes granules and extrudes drops of material under high pressure. This fundamental difference with FDM led to the improved ability in printing porous structure with materials that are not possible to process without additives, such as plasticisers that often could have an undesired impact on drug release performance.

Polymorph expert Ruwanthi Gurusinghe will talk Custom Pharma Services' approach to the screening of Pharamceutical Polymorphs.

More than 50% of commercially available drug candidates have more than one polymorphic form. Each morph may show differences in their physicochemical properties such as dissolution rate, bioavailability, physical and chemical stability. Various mechanical and environmental factors may cause unintentional transformations between different polymorphs. The presentation will cover:

An overview to the polymorphism.

• Factors which affect polymorphic transformations.
• The impact of polymorphic transformations in pharmaceutical compounds.
• The importance of identifying the ideal polymorphic phases of drug compounds.
• Polymorph screening techniques including X-ray crystallography, thermal methods, spectroscopic and microscopic.