MP-C Seminars

Effective validation requires a proper understanding of the behaviour of the process, in particular the variation that can occur within the process and how this impacts the process performance – whether the process is capable of being validated or not.

The presentation will discuss the types of variation that can occur within a process, how to manage and measure variation and how the data collected during the initial validation can support CPV (Continued Process Verification).

Regulatory agencies expect good understanding and control of process variation; don’t be left behind!

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.

Robot automation is already in use in the pharmaceutical sector with developments in AI, visualisation and autonomous mobile technologies now opening up new applications. This presentation reviews some of the typical applications and technology trends that will impact the pharmaceutical sector in the near future.

The transformative impact of Pharma 4.0 on compliance packaging systems extends beyond next-level customer satisfaction, and unlocks new business models for pharmaceutical manufacturers. This presentation provides key insights into MTC’s cutting edge digital manufacturing research, comprising system integrations, digital twins, and computational intelligence to enable agile compliance packaging. This talk will showcase how Pharma 4.0 offers a framework for a holistic approach to cost-effective manufacturing systems that rapidly adapt to dynamic customer demands for personalised pharmaceutical tablet packaging. Thereby shaping a future where compliance packaging is highly customised and responsive to evolving regulatory requirements and market preferences.

Goal of the presented study and data is to demonstrate the potential of a fully automated and DoE-based development of new oral solid dosage form (tablet). The combination of DoE and automated execution of each process step offer a new potential to speed up and integrate more quality-in-design in the development process.
All development steps were planned by Design of Experiment. For the granulation an automated fluid granulation module was used. All different powder granules were compressed on rotary tablet press with an integrated and automated change of 2- and 3-paddle-feeder and other compression parameters. All tablets were analyzed on an automated WHT with integrated micro-wave based weight measurement and NIR-based content uniformity measurement.
With a semi-continuous fluid bed granulation module 26 different lots of fluid-bed granules with different API-content, humidity and process parameter were prepared. The 26 lots were then automatically compressed on rotary press with different process parameter and an automated 2 and 3-paddle-feeder and wing change to get more than 200 different tablet lots (each > 500 tablets). All of the tablets were than characterized on a new high-throughput-inspection machine with weight, hardness, dimensions and content uniformity. Based on the large number of samples with different process parameter the influences and interaction of materials, recipe and formulation with the process parameter of granulation and compression were analyzed.
Based on the automation of all development steps (granulation, compression and quality analysis) a high throughput and short development time was achieved. Based on 26 formulations, more than 200 tablets lots were prepared, each of them more than 500 tablets. All tablets were tested on a new tablet analysis tool, measuring weight, dimension and API content. By the combination of DoE and automation it's possible to screen a larger parameter space, identify interaction of parameters and optimize the quality of the tablets. By the automation also the required amount of material is less than by a manual testing and change of the different modules like 2- and 3-paddle-feeder.

Twin -crew extrusion (TSE) is a common technique within the plastics industry and one which has translated across to pharmaceutical processing. The use of TSE in pharmaceutical applications is widespread and spans implantable medical devices, amorphous solid dispersions for oral delivery and more recently, as a means of manufacturing cocrystals via mechanochemical synthesis.

Traditionally, cocrystals have been manufactured using solvent-intensive methods, such as, solvent evaporation, cooling crystallisation, reaction crystallisation and slurry conversion. Currently there is a drive towards more environmentally friendly processes that are capable of driving chemical reactions in the absence of solvents. To get a high quality cocrystal yield attention needs to be given to the processing parameters of the manufacturing technique.

Solid dispersion is still one of the hot topics in the pharmaceutical industry. This presentation takes us to another lever were we discuss the down streaming process example which many formulators face issues especially when you use cellulose derivatives. We look at the options of using HPMCAS in hot melt extrusion and how you can overcome an issues you face when milling the extrudates or producing pellets. Another issues that formulators face is scaling up of spray dried material and how that has an impact on the release profile.

Methylene Blue (MB) used for photodynamic therapy (PDT); is one of the promising anti-cancerous and photo-activatable antimicrobial drug. The limiting factor of MB therapy i.e. decreased cellular uptake can be prevented by encapsulation in liposomes. Various liposomal formulations loaded with MB were formulated and investigated for their osmolality, size, poly dispersity index (PDI), zeta potential, pH and drug entrapment efficiency. Formulations were processed at 100 & 200 MPa; one and two passes using MCD (1Y62, 2Y62, 2Z73, 3Z73) and PG technologies of high pressure homogenisation technique. Optimisation parameter was higher encapsulation efficiency and narrow size distributions. Formulations processed through MCD (1Y62) at 100MPa demonstrated relatively significant drug entrapment efficiency with narrow size distribution compared to other PCDs in MCD and PG technology. Study demonstrated that MCD technology yields more promising results than PG for designing of optimised MB liposomal formulations.

Physicochemical, ex vivo and invertebrate tests and analysis centre (PEVITAC) is a centre set up at the University of Reading to offer services to industrial customers. These services include consultancy and experimental tests on physicochemical characterisation of formulations, analysis of muco- and bioadhesive properties, drug/particle penetration studies, toxicological assessment of formulations using ex vivo animal tissues and live invertebrate models. We also provide evaluation of biological activity of compounds using live invertebrate models. PEVITAC offers contract-research testing services for assessment of specialty chemicals, pharmaceuticals, cosmetics and toiletries, agrochemicals and pollutants.

In this presentation, Dr. Enosh Mwesigwa will discuss the pressing need for complexity reduction in pharmaceutical formulations, through two insightful case studies. By embracing simplicity, for instance, through the adoption of multifunctional and high performance excipient technologies, formulators stand to benefit from streamlined processes, efficiency gains, and cost-effectiveness, and ultimately, increasing chances of earlier success in product development.