24 April 2024 Seminars

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.

Homegrown 3D printing was thrust into the global mainstream as a temporary healthcare solution to support efforts to fight COVID-19, but with global supply chains still reeling from the pandemic, there continues to be a focus on building resilient, long-term, production capabilities across the pharmaceutical industry. This presentation takes a unique approach to detailing how the role of the three pillars of industrial 3D printing goes far beyond a stopgap and describes how innovative pharma manufacturers can take advantage of this technology to drastically reduce downtime, improve supply chain security and make significant efficiency gains.

Quality Risk Management or QRM is used for identifying, assessing, and mitigating risks, and it is a critical part of an effective pharmaceutical quality system to effectively control the production and distribution of medicinal products. The industry standard for QRM, ICHQ9, has been around for nearly twenty years now, and the most recent revision, ICHQ9(R1), was just last year reissued to update and correct some deficiencies in the original text.
A good QRM process will list all potential risks associated with the product or manufacturing process under review using science-based decision-making. QRM should be embedded in the QMS with its own procedure to outline how risk assessments are determined, including the level of formality and type of assessment to be used. Risk analysis/assessment tools identify and assess hazards, while risk control is used to minimize or manage risk to acceptable levels. The QRM process itself involves making decisions for each hazard on the severity, probability of occurrence, and detectability.
Pharmaceutical manufacturers and distributors can and often do fall foul of not correctly utilising QRM principles in their competent authority inspections, leading to inspection non-compliance findings. For example, in your change control process, could you put your hand on your heart and say that all risks in all change controls are identified and assessed and appropriate risk mitigation strategies implemented to ensure that the products meet all critical quality attributes? Also, with the revised Annex 1 now effective, can we be certain that cross-contamination risks are all fully addressed to ensure that residues will not contaminate subsequent batches?

In this presentation, I intend to give an overview of effective QRM processes, when risk management should be used, and the pitfalls to avoid. I will also give some examples of really effective QRM tools suitable for various situations where risk assessments should be used and tips and advice on how to use these tools.

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.

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.

Despite being a payments technology company, Mastercard struggled to improve the efficiency of its supply chain payments operations, and we'd like to understand how this compares with pharma, which will be far more complex
- Mastercard has 30,000+ Purchase requisitions a year across 180 countries
- Payment terms were disparate – we aimed to standardise terms across our supplier base
- We created a tool called Global Treasury Intelligence to become the “air traffic control” for Mastercard’s Sourcing and Supplier team
- It’s given us visualisation across our ERP and Procure to Pay systems unified into a single interface, enabling us to drill into the data (historically has needed to be manually joined)
- Benefits include: visibility into multiple payment terms; payment timing; payment method; contracted vs non-contracted spend - all in one place
- We spend 75% less time on manually joining data points, make greater use of cards for supplier payments, and we can use this to negotiate better terms with suppliers
- We see this area as ripe for innovation in pharma - where payments often remain analogue, manual and costly

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.

• Overview of supply chain challenges
• Supply chain management and impact on QP’s & RPi’s
• Case study
• Key learnings

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

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.

Auditing is a very important aspect of any Quality Management System, and is a specific requirement of both GMP and GDP. However, often audits are preformed as part of person's very busy schedule, with limited planning and preparation for the audit itself, resulting in the audit not being as effective, efficient and professional as it could be. In this lively presentation we will cover some of the main activities to be performed at the planning stage of any audit, including what to ask for in advance and how to review documentations in advance to get an appreciation of the organisation before you arrive on-site.

Pharmaceutical 3D printing is a rapidly growing field, set to change the world of pharmaceutics forever. With the ability to fabricate small batches of precise structures and personalised dosage rapidly, pharmaceutical 3D printing makes personalised medicine safer and more accessible. It also has the ability to drastically improve patient treatment adherence, with personalised colour, flavour, shape and drug combinations (polypills). This technology is now being analysed for different drugs in clinical studies across the world. This presentation will go though the exciting updates the field has to offer, including clinical studies, regulatory updates and how to get involved.

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In 2023 the majority of available medication is still mass production and shelf medication. While gender science, weight and bioavailability differences, special needs in pediatric medication or psycho-actives in particular shows us, that a one-fits-all medication has overcome long since, pharmaceutical industry has still not turned direction.

Personalized dosed medication is the future of health treatment and a requirement of our time to improve side effects, reduce waste of pharmaceuticals and fight medication shortages.

How do you know if you are inspection ready? Being able to demonstrate GMDP compliance is essential to avoid additional costs, licensing delays and reputational damage.
The presentation will cover what being inspection ready means in practice based on insights from former MHRA Inspectors, highlighting expectations for PQS documentation, completion of operational activities, and examples of how to leverage output from the PQS to confirm GMDP compliance. How to prepare for a regulatory inspection will also be discussed, highlighting practical considerations for hosting the inspection and advice on how to present information to demonstrate GMDP knowledge and compliance.

Drug development is a lengthy, complex and expensive activity, which leads to a large temporal discrepancy between scientific discoveries and their use in clinics. Intra-target Micro-dosing trials attempt to shorten this delay by delivering a safe, low, non-therapeutic dose directly at the disease site to extract important pharmacodynamic data to assess API efficiency from the target patient cohort. The manufacturing and regulatory context differs from classical clinical trial, and the platform set up by the Translational Healthcare Technologies group of the University of Edinburgh answers these specific needs.

Presentation on the supply chain giving a visual demonstration and talk of each of the points. Each point will highlight the risks involved and possible mitigations. We will include elements of temperature management packaging and how this can aid successful distribution, as well as the different carrier options available.

20 minutes will be spent interacting with the audience. We will show an FMEA model example of a pharmaceutical export route and ask members of the audience to volunteer the risk identificationa and scores and how this can be mitigated. This will then conclude in a completed lane validation and the audience will have an understanding of how to complete.

[vc_row][vc_column][vc_btn title="To book a place on this workshop, please click HERE" style="outline-custom" outline_custom_color="#000d66" outline_custom_hover_background="#000d66" outline_custom_hover_text="#ffffff" align="center" button_block="true" link="url:https%3A%2F%2Fwww.makingpharma.com%2Fworkshops/its-different-in-pharma%2F|target:_blank"][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Pharmaceutical distribution is tightly regulated by the rules and regulations of GDP (Good Distribution Practice).

This session sheds light on the Rules, Regulations and Guidance that dictate Good Distribution Practice (GDP). Exploring GDP standards set by diverse regulatory bodies, we will scrutinize the similarities and differences among UK/EU GDP, WHO GDP, and FDA GDP, and ponder the differences between GDP and GMP.

Expect a dynamic session featuring succinct presentations, engaging group exercises, and lively panel discussions. Join us for an interactive session that will give you fresh insights into the contrasts, commonalities and nuances of GDP in different jurisdictions and across different regulatory bodies.

The session will be a lively, interactive mix of (brief) presentations, group exercises and panel discussions.[/vc_column_text][/vc_column][/vc_row]

• Temperature monitoring and how to handle temperature excursions in the supply chain.
• Ensuring correct storage of medicines, end-to-end from manufacturer to patient.
• Management and calibration of temperature equipment.
• Temperature mapping of warehouses, cold stores and cold-chain vehicles.

A comprehensive look at how your choice of primary packaging can impact time to market.

We start by covering the minimum requirements for primary parenteral drug packaging – ensuring that the packaging that comes into direct contact with your formulation meets standards set out in the EP, JP and USP.

From there we talk about specific challenges faced by those in drug development, including problems with freeze drying, formulation sensitivities, conforming to the principles of Annex 1, and the part packaging plays in both the problem and the solution.

We provide a guide to the possible solutions, all presented in an informative presentation.

Are you an engineering designer for a new QC Lab? Or a Commissioning Manager on a Biotech suite? Or maybe you’re a Fill & Finish facility Ops Manager? While you manage the GMP risks, it is important not to underestimate the Process Safety risks linked to the equipment and utility systems in your facility.

Historically secondary pharmaceutical manufacturing and biopharma have been seen as having relatively few Process Safety hazards. However, serious incidents still occur – what are they and why do they keep happening? Join this presentation to learn what more we might do to avoid and manage these risks.

In this presentation, I will aim to explore the challenges and benefits associated with using a 3PL provider and choosing the right one. I then will explore the journey of the change from in-house warehousing to a 3PL. My discussion will span various considerations, from selecting the appropriate 3PL to the preparation and actual transition process, along with the impact on GDP in these areas. Drawing from practical observations, both the advantages and challenges will be discussed.

[vc_row][vc_column][vc_btn title="To book a place on this workshop, please click HERE" style="outline-custom" outline_custom_color="#000d66" outline_custom_hover_background="#000d66" outline_custom_hover_text="#ffffff" align="center" button_block="true" link="url:https%3A%2F%2Fwww.makingpharma.com%2Fprotecting-people-protecting-the-environment-designing-sustainable-pharmaceutical-lifecycles-for-the-future-european-regulatory-landscape%2F|target:_blank"][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Synopsis

Following the launch of its 2020 Pharmaceuticals Strategy for Europe, the European Commission (EC) adopted the first draft of a new directive and regulation in April 2023, opening it up to public consultation. This workshop will

• review the new environmental protections offered under the proposed legislation and the associated requirements placed upon pharmaceutical manufacturers to assess the environmental impact of the entire lifecycle of a product, from manufacturing, through use, to disposal, and
• highlight work being carried out in the ETERNAL project to visualise the interconnected system of socio-economic activity of which a typical pharmaceutical lifecycle is comprised, and to locate and assess the impacts of this activity.

Format

Short presentations will introduce both the context and substance of the proposed changes to EU legislation and the emerging results of collaborative research being presented. With the scene set, the second part of the workshop will be driven by dialogue with the audience to capture views both positive and negative on the prospective legislative changes and how new tools for process and system design, and better understanding of the environmental fate and eco-toxicological effects of pharmaceuticals can help those seeking to build compliance into their businesses. (45 minutes estimated duration)

Output

Workshop participants will benefit from a concise update on the key features of an important piece of emerging trans-national legislation and the chance to consider its implications for their own organisations. The perspectives of workshop participants from across the pharmaceuticals value chain will be captured and used by the ETERNAL project to help inform and direct work to produce a roadmap for integrating new scientific knowledge into regulatory risk assessment to target mitigations, modifications, and management strategies, ultimately towards a greener, more sustainable environment.[/vc_column_text][/vc_column][/vc_row]

On 25 November 2020 the European Commission (EC) published a pharmaceutical strategy document, which they said was the first step in a “complete overhaul” of the medicines legislative framework for human medicines to be proposed in about two years’ time. Commission vice-president Margaritis Schinas told a press conference on 25 November 2020 “We will be completely overhauling the entire legislative medicines framework – a set of rules that is 20 years old and badly needs modernisation”.

The presentation will look at the most important changes in the EU HMRs including those that directly impact UK manufacturers and I plan to discuss the impact of the Windsor Framework.

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.

The Government of the United Kingdom (UK) introduced temporary measures to address problems with the supply of medicines to Northern Ireland in the wake of the UK’s withdrawal from the European Union (EU); both the UK and EU recognised that there were difficulties in operating the “Protocol on Ireland and Northern Ireland”, an agreement intended to protect the terms of the 1998 “Belfast Agreement” and preserve the close relationship between the Republic of Ireland and Northern Ireland.

These temporary measures (such as the Northern Ireland MHRA Authorised Route, “NIMAR”) were considered necessary by the UK, as the implementation of the Protocol on Ireland and Northern Ireland had created supply chain issues which impacted on public health in the region.

Despite these temporary measures, there was evidence that supply problems persisted – this was seen not only for medicines, but other areas of trade between Great Britain and Northern Ireland as well.

On 27 February 2023, the UK and EU published the “Windsor Political Declaration by the European Commission and the Government of the United Kingdom”, which is also known as the “Windsor Framework”. This framework, which was adopted by the EU-UK Joint Committee in March 2023, applies to trade between Great Britain and Northern Ireland whilst aiming to protect the EU market. This presentation will summarise the framework and MHRA expectations for the licensing & supply of medicines across the UK going forward.

The presentation will explore the DI and CSV challenges faced for new start-up companies progressing towards regulatory licence. Recent years have seen a vast increase in the volume of new organisations starting up especially in the areas of Cell Gene Therapy, mRNA and DNA technology.

While these organisations may be leading edge with regards to the science and technology, of the aspect of DI and CSV compliance is seen as a secondary or even lower priority - until the aspect of submission for licence inspection occurs.

In addition to the pure DI and CSV journey there are a number of additional areas that need attention during this journey, the presentation will draw on the experience gained in the last 2-3 years helping a number of clients on this journey to successful licence.

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.

When considering the installation of a temperature controlled storage facility for pharmaceutical products, whatever the URS specification, or basis of supply (capital outlay, rental, lease arrangement etc),

What are the 5 basic skills a potential supplier must tick to support you and your company?

During our presentation, I will cover off in more detail the 5 points above and point you in the right direction for a successful supply of a pharmaceutical temperature controlled environment.

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.

• How to navigate the intimidating scale of the supply-side
• What you need to ensure your API supply chain is compliant
• API testing: no chemistry, but examples of problems that can arise between labs