30 April 2025 Seminars

The presentation will outline how to build and quality the facility, how to prepare for the licence application. How to obtain the licence. How to ramp up to routine production. Differences between sterile and non-sterile manufacture. Team requirements for a new facility.

How to scope and budget the project and communicate to senior management. Common pitfalls and errors. How long do projects typically take. What you can get out of participating in a new build.

This presentation explores labeling compliance strategies in the pharmaceutical industry, focusing on the critical role of automated proofreading to ensure labelling accuracy.

Accurate labelling is essential for compliance with regulatory requirements, safeguarding patient safety, and preventing counterfeiting. Despite these important factors as well as the availability of automated proofreading tools, many Pharmaceutical companies are still relying on reviewing and proofreading their labelling documents manually. Automated proofreading tools streamline the verification process, reduce the risk of errors in text and graphics and ensure that labels meet stringent regulatory standards. By integrating automated solutions, companies can enhance the efficiency and reliability of their labelling processes, ultimately protecting patients from potential harm and maintaining the integrity of their products in a competitive and highly regulated market.

Traditional internal audits check process risks by determining the adherence to controls. A risk based internal audit assesses the controls which create the most significant exposure to the achievement of the organisation’s objectives.
How you can use AI, PRNs and KPIs to build risk based Agile audits which will deliver insights on whether business and management controls are working as intended to reduce risks and achieve objectives.
How do you deliver a risk-based compliance audit which aligns with both a risk and audit universe?
What does a risk-based QMS look like and how can a business become quality centric?

The Pharmaceutical Quality System (PQS) is always a focus of regulatory inspections, whether that be documentation, deviations, changes or CAPA effectiveness yet it is consistently an area of non-compliance observations. Why? The PQS should be seen as a holistic function with all individuals and teams operating in harmony to identify, impact assess and resolve deficiencies quickly, thereby mitigating future risks. The goal of senior leadership should be to establish a mature quality culture across their organisation. This will achieve lower levels of non-RFT, higher levels of continuous improvement, improved efficiencies and morale, ultimately leading to lower attrition and a better understanding of GMP and risk.

Artificial Intelligence will have a profound impact on everyone attending this conference. However, many are confused by what it is, how it works and concerned by what it will do. The purpose of this 30 minute session is to help you understand more so that you may fear less.

How to create checklists as part of the preparation for internal and external GDP audits. This presentation looks at how an auditor should refer to the standard first, in the planning stage of an audit, to establish exactly what the requirements of GDP are in the first instance. The checklist can then form the basis of questions to ask, when on-site, and as an aid to making notes.

In response to the amplified need for sustainable pharmaceutical supply chains and consumption patterns highlighted by events such as the COVID-19 pandemic, the ETERNAL project focuses on ensuring ongoing access to safe, high-quality, and effective pharmaceutical treatments while minimizing the environmental impact. The project embraces a full life cycle approach, encompassing design, manufacturing, usage, and disposal phases, and evaluates the environmental risks associated with active pharmaceutical ingredients, residues, metabolites, and other production-related by-products. Particular emphasis will be placed on advances in new solvent-free and continuous processing techniques in the preparation of medicines, thus adapting to the production requirements of the market and the increasingly high standards of sustainability.

This presentation looks at the key challenges in packaging complex medicines like biologics, gene therapies, and new mRNA drugs. It highlights the challenges of deep freezing in gene therapies and discusses the risks from leachables extractables, which can change the pH of complex pharmaceuticals. These changes can lead to issues like protein clumping, the creation of solid particles, and the inactivation of important drugs, such as monoclonal antibodies. Addressing the importance of evaluating different specialty packaging options during early stability studies to reduces these risks and ensure that the drugs remain effective throughout their lifecycle.

In an ever-evolving pharmaceutical market and a highly competitive employment landscape, it is crucial for individuals and organizations to stand out from the competition. Without a harmonized workforce, the core of these organizations, the “making” and “distributing” of pharmaceuticals can be affected.

The purpose of this talk aims to provide valuable insights for attendees, offering guidance from a recruiter's perspective on how individuals can enhance their chances of securing the best roles, whether contract or permanent, and how employers can attract top talent. Recognising the networking opportunities provided by the conference, this session will particularly benefit those in attendance.

During the presentation, three key areas will be explored:

1. Understanding the recruitment landscape: Exploring the shift towards consultancy roles, the long-term implications for the industry, available training and development opportunities for individuals, as well as changes in hiring and onboarding processes for companies.
2. Thriving culture for employers: Strategies for creating an environment that fosters growth, challenges employees appropriately, and maximises staff retention.
3. Empowering employees: Unveiling ways to optimise current employment situations, maximise chances when applying for roles, and differentiate oneself from other applicants.

Through real-life examples, this talk will showcase successful companies that have implemented strategies to harmonise their cultures, providing attendees with valuable insights and actionable steps for personal and professional improvement.

3PL companies need to comply with Good Distribution Practice regulations. This is being checked by the contract givers (typically the Marketing Authorisation Holders) through audits.
There are different ways of performing these audits, e.g. questionnaires, remote / virtual audits or in person on site audits. Based on many years' experience, the advantages or disadvantages, the benefits and pitfalls ofthese audit approaches are presented and discussed. The information is supported by case studies to illustrate the points made.
The 3PLs covered include warehousing, and road, air and ocean distribution.

The EU Fit for 55 focuses on specific topics that need particular attention and a strong green transition to achieve climate neutrality.

Within the ETERNAL project we have a focus on the application of Energy Efficiency Directive to the Pharmaceutical sector

Article 3 of the revised EED directive (EU/2023/1791), published in September 2023, provides a stronger and wider legal basis for the application of the principle “Energy Efficiency First”

Article 3 sets an obligation for EU countries to ensure that energy efficiency solutions are considered in planning, policy and investment decisions in both the energy and non-energy sectors.

Article 3 requires EU countries to develop and ensure the application of cost-benefit assessment methodologies that include proper assessment of the wider benefits of energy efficiency solutions from the societal perspective

The ETERNAL project will present how existing methodologies can be applied to show cost-benefits and develop new methodologies to assist asset owners in the pharmaceutical sector achieve higher energy performance for the energy services that are needed for production

A focus on energy services approach can provide a production driven design for sustainability, with energy performance criteria for equipment selection

Merging implementation science with smart pharmaceutical packaging can revolutionize both healthcare and sustainability. Implementation science, which focuses on translating research into real-world practice, ensures that smart packaging solutions—such as RFID-enabled systems for monitoring dosage adherence—are effectively adopted by healthcare providers and patients. When designed with sustainability in mind, these technologies reduce waste through precise inventory management, limit the need for excess production, and promote the use of eco-friendly materials. This approach not only improves patient outcomes but also aligns pharmaceutical practices with environmental sustainability goals. So, I would like to address the implementation science for the audience to bring more ideas and techniques to the smart packaging and to give insights of reducing the gap of 17 years needed to bring new medical ideas from research to the pharmaceutical market! Smart packaging benefits both pharmacists and patients by enhancing medication management and improving safety. For pharmacists, it facilitates better control over medication dispensing, preventing errors. For patients, features like digital reminders, adherence tracking, and interactive information through QR codes or NFC technology help ensure proper dosage and timely consumption. Combined, these tools support better health outcomes and foster more efficient pharmaceutical services.

You can submit your questions for this panel, which will be selected by the Chairperson for the session.

How to create checklists as part of the preparation for internal and external GMP audits. This presentation looks at how an auditor should refer to the standard first, in the planning stage of an audit, to establish exactly what the requirements of GMP are in the first instance. The checklist can then form the basis of questions to ask, when on-site, and as an aid to making notes.

HVAC in pharmaceutical production and/or distribution facilities represents the largest single element of facility CO2 footprint and one of the largest energy costs. Addressing it is a key step to decarbonisation and cost savings. On-Site Energy will explain energy and decarbonisation trends, as well as share case studies of the application of innovative technologies and integration with renewable energy. David will then explore the pros and cons of delivering solutions on a standard Capex basis vs a third-party's off-balance sheet PPA model.

Hydrogen peroxide (H2O2) is widely used in pharmaceutical manufacturing but presents significant safety challenges due to its reactive and hazardous nature. This presentation will focus on best practices for detecting and managing H2O2 exposure, ensuring worker safety and compliance. We will explore effective H2O2 detection methods, critical factors in selecting personal protective equipment (PPE), and common pitfalls that compromise safety. Additionally, attendees will learn how to develop an integrated, end-to-end prevention strategy, combining real-time monitoring, risk assessment, and protective measures to mitigate hazards and ensure a safer pharmaceutical manufacturing environment.

1. Assessing Current Practices:
   This part examines the cost, resources, and time required to implement current best practices, using a detailed example of a batch manufacturing process—tracing steps from raw material procurement to the release of the final batch.
2. Exploring Advancement Opportunities:
   This collaborative segment delves into potential innovations in areas like supply chain, warehousing, manufacturing, packaging, quality control, quality assurance, regulatory compliance, and research and development.
3. Identifying Challenges and Risks:
   Guided by the presenters, this section tackles significant challenges encountered during the transition to becoming smarter, more agile, and intelligent, while also addressing the risks of staying behind in this evolution.
4. Journey of GMP Manufacturing Ltd:
   An illustrative example of developing a cutting-edge, intelligent, and agile factory, showcasing GMP Manufacturing Ltd’s progress as a leading CDMO (Contract Development and Manufacturing Organization).
5. Engaging Interactive Q&A:
   Closing with an engaging question-and-answer session, this segment invites active audience participation and contribution.

The presentation is showing the significance of ESG regulations in today’s supply chain landscape, main requirements, critical points to control and responsibility that can be transferred to downstream/suppliers. The practical advice is to be shared on how to move from discussions on sustainability to clear actions within procurement department: Tier 1&2 suppliers assessing for carbon footprint contribution, auditing, cooperation on Science Based Targets achievement. Particular examples will be introduced on the sustainability platform (Ecovadis) and sustainable packaging solutions in pharmaceutical industry.

This research explores the evolution of blockchain technology in pharmaceutical supply chain management (PSCM), emphasising its potential to address cybersecurity threats and counterfeit drugs. Blockchain's transparency, immutability, and other features make it an ideal solution for PSCM. A systematic review of various blockchain platforms, including Hyperledger and Ethereum frameworks, highlights the trends and applications over time, particularly around the COVID-19 pandemic. The study identifies key developments including the rise of decentralised applications and the integration of blockchain with the Internet of Things, artificial intelligence, and machine learning. Despite its growing use, challenges like immutability remain a concern for PSCM stakeholders.

The presentation will aim to illustrate the regulatory evolutions related to NAs, moving from general ones to nitroso APIs. The crucial point will be the analytical approach to the different matrices in function of the MDD of the drugs and the different limits foreseen for each impurity. The presentation will also include different case studies.

The RESILIENCE Medicines Manufacturing Skills Centre of Excellence creates and delivers training courses for the UK medicines manufacturing community, including industry, NHS and education providers. The Centre is engaging with end users to ensure training adapts to keep pace with evolving technology and sector priorities, such as digital technology, artificial intelligence, data analysis and environmental sustainability. Benefits for educators include access to high quality, readily scalable core materials for training and outreach. Industrialists can accelerate skills development in the business, access industry-ready new graduates, and transfer talent to address any skills gaps in the organisation. This presentation will provide an overview of how the Centre is building approaches to develop and nurture the UK talent pipeline through education, mentoring and outreach, and steps towards scaling-up talent growth across the UK through an affiliate membership network, giving widespread access to educational and outreach materials. 

The skin, as the largest organ of the body, is vulnerable to damage from numerous sources, which can complicate the wound healing process. Conditions such as aging, diabetes, and obesity can hinder natural healing, resulting in extended inflammation and slower recovery. Nanomaterials, with their customizable properties, offer promising solutions for biomedical applications. Devices engineered with nanotechnology, particularly electrospun nanofibers, provide advantages over conventional dressings, including flexibility, precise drug delivery, gas exchange, and enhanced biological effectiveness. This study attends to the mechanisms behind chronic wound formation and the use of synthetic polymers to create bio-inspired nanofibers through electrospinning, aiming to enhance healing. This study aims to investigate the impact of electrospun nanofibers on wound dressing applications, focusing on polycaprolactone (PCL) and poly (lactic-co-glycolic acid) (PLGA) polymers (5% and 10% concentration) loaded with cannabidiol (CBD). By employing a single electrospinning apparatus, successfully nanofibers were synthesized that exhibited unique properties with desired characteristics based on the Electrohydrodynamic Atomization (EHDA) process moreover comprehensive assessments were conducted to confirm the suitability of nanofibers loaded with CBD for wound dressing applications. The rheological properties of solutions are critical for their effective application in the EHDA process, as the formulation must exhibit specific physical characteristics. This study emphasized the importance of conducting thorough physical characterization of solutions and there was an inverse relationship between increasing concentration and the rise in electrical surface tension (ST) and conductivity (EC). However, an increase in polymer concentration led to higher density (D) and viscosity (V). These parameters are essential to ensure the solutions meet the necessary criteria for successful EHDA processing. In Zeta Potential Results, the high negative zeta potential demonstrated a good degree of stability for nanofibers and enhanced bioavailability of CBD.  The CBD-loaded nanofibers exhibited improved stability confirmed by by the Optical Microscopy with smooth fibers. Thermal analysis revealed a slight decrease in melting temperatures for PCL (~57.84 °C) and PLGA (~44.12 °C), suggesting the formation of smaller crystallites and successful encapsulation of CBD. Fourier-transform infrared spectroscopy (FTIR) confirmed the integration of CBD within the polymeric chains, although the final nanofibers did not exhibit detectable CBD peaks.  The in-vitro release study demonstrated that PLGA nanofibers achieved 100% CBD release within 48 hours, with an initial burst release phase and control release for 48 hours, PLGA nanofibers released approximately 65% of the drug within 30 minutes, while PCL nanofibers released 55% within 40 minutes. Kinetic modeling indicated the Higuchi model best described the release mechanisms for both formulations while the faster drug release from PLGA nanofibers was attributed to higher bioerosion compared to PCL. The study underscores the potential of nanofibers in wound dressing applications. Future research will concentrate on optimizing electrospinning parameters, enhancing fiber properties through surface modifications, and investigating in vivo behavior. Additionally, the use of wound kits to test wound dressing and some culture studies for targeted wound healing applications will be explored.

The Pharmaceuticals sector is, by its nature, highly regulated and CAPEX-friendly. These conditions are powerful drivers of quality and long-term progress but have the potential to suffocate daily operational improvement and stifle true manufacturing excellence. An antidote for this is having a truly effective Improvement Cycle embedded at the heart of operations.

The Improvement cycle is simple in its concept – 4 key stages driving daily improvement: Getting the Right Facts, Understanding & Prioritising, Getting People Working Effectively, Using the right Improvement tools & actions – and yet fiendishly difficult to implement in a world-class manner.

Chartwell are operational improvement specialists, working across all manufacturing industries but with a particular focus in pharmaceuticals. We help achieve capacity & productivity improvements in this sector of 20-50% within 3-6 months with little or no CAPEX. How? An industry-leading approach to the improvement cycle, coupled with rigorous application of structured methodologies.

In this presentation, I’d like to use the opportunity to share with the conference attendees some key principles they can take back to their companies to help rapidly strengthen their Improvement Cycle and benefit from a step-change improvement of their current assets.

In a scientific data driven sector we must transition our understanding and communication around sustainability from qualitative to quantitative. Quantifiable metrics and shared tools enable better communication and collaboration, which is vital considering most emissions lie in supply chains. To address this, we need good (not perfect) data available to access.

We’ll give an overview of some key sustainability metrics and tools that enable targeted strategy and actions, while making it possible to capture and communicate progress more meaningfully. Covering ‘Carbon’, PCFs, and LCAs, including what they are, their value, limitations, and key challenges with examples, including LCA case studies.

This presentation will address the growing demand for vegan/vegetarian alternatives in pharmaceuticals and the research carried out to formulate chewable tablets optimized for vegan/vegetarian populations. Chewable tablets, known for their ease of use and enhanced patient compliance, will be formulated using direct compression and non-animal-derived excipients. This research project will formulate and characterise new chewable tablets for the vegan/vegetarian populations by leveraging direct compression, optimizing non-animal-derived excipients and functional efficacy. Comprehensive characterization will align with British Pharmacopoeia standards, evaluating properties such as powder characteristics, mechanical strength, and dissolution, aiming to create innovative solutions that meet both dietary and therapeutic needs, improving patient care and inclusivity.

The gut microbiota serves as a dynamic hub of activity within the gastrointestinal tract, profoundly influencing nutrient and drug metabolism, immune modulation, and pathogen defence. Emerging research underscores its pivotal role in the gut-brain axis, revealing intricate mechanisms and pathways that connect gut health to neurological function. This talk will delve into cutting-edge findings on the potential of modulating the gut-brain axis as a transformative therapeutic strategy for managing neurological disorders. It will also explore the future opportunities that lie ahead, from innovative drug delivery systems to personalized microbiome-based interventions, while addressing critical challenges such as regulatory hurdles, safety concerns, and the need for robust clinical evidence. 

Quality and cost are the two big drivers of the modern oral solid production. Mega batch and the continuous mini batch approach are two different ways to reach this goal. At first glance it seems that both solutions are completely the opposite of each other. With a closer look both solutions have a lot in common to improve quality and to reduce cost in the life cycle of the product. In this presentation both solutions will be highlighted, case studies will be given and solutions for both possibilities will be shown.
Mega batch and continuous production are both possible ways into a highly automized oral solid dosage production.

Excipients are inert in terms of therapeutic benefit to the patient, but they play an increasingly critical role in delivery of the therapy to the patient. With therapies also broadening from traditional chemical-based agents into biologics, as well as combination products and even medical devices, what then is an excipient? And for the new technologies, how can existing excipient guidelines and approaches be applied? 

Brexit has had significant impact on the pharmaceutical industry, with particular impact on the supply chain covering both import and export.
The UK is now considered a third country and the impact of this includes increased inspection for competent health authorities, changes to supply routes, changes to medicines offered in specific markets and changes to process (for example, EU QP release and testing, and RPi).
The Windsor Framework focuses specifically on the continued supply into Northern Ireland and Republic of Ireland, and there has been significant impact to the supply chain including longer lead times, reduced range and increased process (to increase even further from January 2025).
A requirement for the greater focus on supply chain mapping.

Nick Carter has worked in the international trade of raw materials for the pharmaceutical industry for over 35 years. Any new product development or change control for an alternative source of an API comes with huge costs and he is keen to share his experience of mitigating the many risks associated with the API supply process.

Annex 1 states that continuous viable air monitoring in Grade A should be undertaken for the full duration of critical processing, including setup.

This presentation challenges the suitability of the settle plate method and the most common active air sampling methods. Furthermore it challenges the suitability of the current TSA media for use in this application.

Data will be presented to prove and justify that current methods are ineffective in achieving continuous monitoring and as an industry we should be looking to new TSA media formulations and new sampling techniques (data presented) that are more suited to this application.

This talk explores the innovative technique of suspended layer additive manufacturing (SLAM) for 3D bioprinting soft tissue models. It demonstrates how SLAM overcomes traditional bioprinting limitations by using a supportive fluid gel medium, enabling the creation of complex, soft tissue structures with high resolution. The presentation will cover the principles behind SLAM, its advantages over conventional methods in generating physiologically relevant tissue models. It will also demonstrate how SLAM has been used for fabricating interfaced tissues, that have controlled spatial gradients in mechanical, chemical and biological properties within a single structure and highlight their potential to be used as tissue engineered implants or as models for drug screening.  

Discrete Element Method (DEM) simulations offer a powerful tool for predicting the behaviour of bulk powder systems in pharmaceutical manufacturing. However, these simulations require accurate calibration, which typically relies on substantial material quantities. In the early stages of API development, only limited amounts of powder are available, posing a challenge for effective calibration.

We propose a method to use micro-quantities of API for calibrating DEM simulations, enabling accurate predictions for larger-scale systems. By targeting key particle properties—such as compressibility, cohesion, and shear strength—we demonstrate how small samples can be leveraged to align DEM outputs with the performance of full-scale pharmaceutical processes. This approach not only facilitates early-stage development but also supports sustainable practices by reducing material waste and expediting the design of equipment like tablet presses and blenders, setting a new standard for efficiency in pharmaceutical development.

Managing industrial assets in pharmaceutical manufacturing is crucial for ensuring efficiency, compliance, and safety.  Engineers consider all elements from accurately registering assets, having the right preventative and predictive maintenance regimes based on risk management and building competency in staff.  Data driven decision making is critical to help identify opportunities for continuous improvement.

Freeze drying, also known as lyophilization, which is the removal of water, is widely used in pharmaceutical formulation for several key reasons:
1. it can enhance the stability of active ingredients that are sensitive to heat and moisture.
2. it can extend the shelf life of pharmaceuticals and enable easier storage and transport.
3. it can maintain the structural integrity of complex molecules, and
4. freeze-dried products can be effectively reconsituted by adding moisture.
This study presents differential scanning calorimetry, X-ray powder diffraction, Fourier transform infrared spectroscopy and Raman spectroscopy data for isomalt, which demonstrate its suitability as an excipient in freeze-dried formulations.
In addition the crystallization tendency of the freeze-dried isomalt samples by storing them in three different relative humidity (RH) conditions (2, 9 and 16%) at room temperature in open vials is explained.

This presentation will cover challenges and opportunities in advanced medicine manufacturing exploring the practical application of latest, proven technologies. 

Real life examples will provide an insight in what will be the norm in future medicine manufacturing.  This in part comes from assessing and adoption of practices from other industries. 

You can submit your questions for this panel, which will be selected by the Chairperson for the session.

You can submit your questions for this panel, which will be selected by the Chairperson for the session.

Compliance challenges can result in product quality issues, supply shortages and threats of regulatory action, which in turn puts increased pressure on a business and individuals. The need to maintain supply whilst trying to implement remediation and compliance improvement activities often results in competing priorities, aggressive timelines, and backlogs in the closeout of deviations and CAPAs. This presentation will help attendees to see the wood for the trees by providing some practical examples of how to use risk management to identify and prioritise the most important actions and maintain perspective critical to GMDP compliance.

Characterising pharmaceutical formulations using biological methods is imperative in ensuring their safety, efficacy, and compatibility with the human body. These methods provide valuable insights into how these substances interact with living organisms, shedding light on their biological activity, potential side effects, and overall performance. Multicell biological models offer distinct advantages over traditional cell culture assays when characterising pharmaceuticals. This talk will showcase the services offered by Physicochemical, Ex vivo and Invertebrate Tests and Analysis Centre (PEVITAC), in particular, the use of live invertebrates and ex vivo mammal tissues in the studies of toxicity and adhesive properties of pharmaceutical formulations.

The pharmaceutical industry is increasingly urged to reduce waste and produce efficient drugs. Commercializing a new drug may cost 1-2 billion USD and 10,000 failing drug candidates. Limited research has been reported on modelling performance of supercritical CO2 (scCO2)-assisted spray drying, a technology with promising adaptability to continuous manufacturing. This presentation outlines our research efforts to develop an accurate and computationally efficient digital twin of the process using Computational Fluid Dynamics modelling augmented by user-defined functions. Process analytical tools ranging from thermal imaging to real-time laser-diffraction based droplet/particle sizing were used to validate and optimize the model.

Established in the 1980s, the primary goal of the Global Responsible Care Programme was to improve health, safety, security, and environmental performance across the chemical sector. Initially focusing on areas such as risk management and product safety, new developments to the scope of Responsible Care now incorporate responsible material sourcing, communication of sustainability metrics, as well social responsibility. The programme’s KPIs measure essential factors like health and safety performance, as well as introducing member companies to new sustainability initiatives and legislation. This talk covers new developments to the CBA’s Responsible Care Programme, outlining how embracing the Eight Guiding Principles of Responsible Care can contribute to a more sustainable and responsible future in the chemical supply chain industry.