Meet various experts from academia, pharma industry, equipment and excipient manufacturers
Day 1 - 17th June 2025
08:15 - Registration
08:50 - Welcome
09:00 - Quality by design (QbD) applied to tabletting: Real world examples (Kendal Pitt)
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Quality by design (QbD) applied to tabletting: Real world examples (Kendal Pitt)
Speaker: Kendal Pitt (former GSK)
QbD can be defined as good science and common sense. Science can be applied during development by assessing the compactability, compressibility, tabletability and disintegration properties of a tablet to ensure a tablet formulation is fit for purpose.
09:30 - Concept of modern drug product development (Thorsten Cech)
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Concept of modern drug product development (Thorsten Cech)
Speaker: Thorsten Cech (BASF)
Time to market and limited quantities of API are pressing aspects in early drug product development. By combining computer aided formulation concepts, with a systematic and scientific based working pattern, both aspects can be addressed successfully. The presentation discusses the benefits of such an approach.
10:00 - Coffee Break
10:30 - Hands-on workshops - small group sessions
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Formulation and process optimisation on R&D rotary press XL 100
Facilitator: Friederike Gütter (KORSCH)
In R&D, formulation properties and tablet press parameters should be aligned to enable optimal manufacturing. Within this practical session tablet press parameter optimisation regarding to formulation properties will be demonstrated.
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Advanced manufacturing and innovations in intensified pharmaceutical coating
Facilitator: Troels Pedersen(GEA)
In this session, we will give examples of pharmaceutical processes when implementing continuous manufacturing. From providing a detailed review of process solutions for future projects, visualising a new facility at an early stage and optimising the set-up before it’s even built, to training new operators without the need to use the physical machinery.
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The art of failure: How to design a terrible tablet
Facilitator: Richard Hawkins & Oliver Deakin (I Holland)
Sometimes the best way to learn is by doing it wrong. In this interactive session, we will explore common design flaws that lead to poor tablet performance, from sticking and picking to capping and delamination. Using real-world examples, participants will examine the impact of poor tablet shape and design features that compromise manufacturability and tablet quality. You'll leave with a clearer understanding of what not to do... and why.
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Formulation development strategies
Facilitator: Nils Rottmann (BASF)
Drug product development must be tailored to the active ingredient to be formulated. Consistently, a sound scientific characterisation is key for a fast and successful development. This practical session allows you to characterise a model API and to deduce formulation concepts, based on the results.
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Design of experiments and data visualisation
Facilitator: Stuart Little (JMP)
This practical session demonstrates how to use Design of Experiments (DOE) to build detailed understanding of your processes. Through this, you’ll gain experience of how to apply the basic principles of DOE to set up designs using a range of factors.
13:00 - Lunch Break
14:00 - Scaling-up of tabletting processes (Friederike Gütter)
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Scaling-up of tabletting processes
Speaker: Friederike Gütter (KORSCH)
Compaction simulation does not only allow for a drug product development with a minimum quantity of API, but it is also a sound base of up-scaling procedures. In small scale essential parameters can be determined, evaluated, and optimised, which are key for a successful production on rotary presses.
14:30 - Workshops - small group sessions
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Evaluation of a powder blend using a compaction simulator - KORSCH / MEDELPHARM
Facilitator: Bruno Leclercq
Compaction Simulator is a powerful tool that advances the understanding of powder blend behaviour during the compaction process. It allows pharmaceutical manufacturers to optimize their formulations, improve tablet quality, and reduce production costs by simulating real-world conditions before scaling up. This workshop will demonstrate how this technology helps ensure more efficient and reliable tablet manufacturing processes.
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Innovations in intensified pharmaceutical coating - GEA
Facilitator: Troels Pedersen
Innovations in intensified pharmaceutical coating focus on improving efficiency, scalability, energy usage, and quality control. System like PharmaCoater™ and ConsiGma™, will be demonstrated combining advanced technologies with modular, automated systems that support the development of high-quality pharmaceutical products while reducing waste and operational costs.
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The science behind tablet design
Facilitator: Richard Hawkins & Oliver Deakin (I Holland)
Tablet design is not just an art, it’s grounded in science and engineering. This session delves into the theoretical principles underpinning successful tablet design. Attendees will gain insights into how design decisions impact strength, visual appearance, and downstream processes, all supported by I Holland’s extensive tooling and manufacturing expertise.
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Employing USP 1062 in the daily working pattern
Facilitator: Thorsten Cech (BASF)
Modern formulation development demands for a systematic investigation of the tabletting blend. This includes the evaluation of compressibility and compactability, both features being the base of the tablettability profile, which is the diagram typically employed for evaluation.
The practical session discusses the advantages of employing USP 1062 in a daily routine and utilising the benefits of the additionally gained information.
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Data visualisation - JMP
Facilitator: Stuart Little
This workshop is a hands on Data visualization with JMP showing a comprehensive suite of tools that make data analysis more interactive, insightful, and accessible. It will show how to enhances decision-making by enabling users to explore, present, and communicate complex data in a clear and efficient way.
17:00 - End of day 1
19:00 - Networking dinner
Day 2 - 18th June 2025
08:50 - Introduction Day 2
09:00 - Manufacturing Classification System (MCS) A proposal for oral solid dosage forms (Kendal Pitt)
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Manufacturing Classification System (MCS) A proposal for oral solid dosage forms (Kendal Pitt)
Speaker: Kendal Pitt (former GSK)
The manufacturing classification system (MCS) is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms based on selected parameters of the API. Depending on its position within each class, the MCS will also inform how robust a manufacturing process is likely to be.
09:30 - Employing continuous manufacturing in modern pharmaceutical manufacturing (Gavin Reynolds)
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Employing continuous manufacturing in modern pharmaceutical manufacturing (Gavin Reynolds)
Speaker: Gavin Reynolds (AstraZeneca)
Continuous processing presents significant opportunities to address the challenges of modern pharmaceutical manufacturing. This presentation will give an overview of the benefits and common technologies used. Key concepts such as residence time distributions and real-time control strategies will also be discussed.
10:00 - Coffee Break
10:30 - Workshops – small group sessions
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Bilayer tablet formulation, from R&D to production
Facilitator: Bruno Leclercq (MEDELPHARM) + Friederike Gütter (KORSCH)
Definition of optimal process parameters to reach tablet quality attributes for a bilayer formulation on STYL’One Evo before production on KORSCH X3 tablet press.
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Smart design, strong tablets: The blueprint for success
Facilitator: Richard Hawkins & Oliver Deakin (I Holland)
Building on the lessons of what can go wrong and theory, this session focuses on the principles of effective tablet design. We will demonstrate how to integrate functional design elements with manufacturability, considering factors such as tooling shape, embossing and other critical tooling design features. Attendees will learn how to create robust, reliable, and user-friendly tablets.
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Employing the virtual formulation assistant ZoomLab™ to assist in early formulation development
Facilitator: Nils Rottmann (BASF)
Digital tools gained an increasing relevance in formulation development. The majority of tools support the formulator in data analysis (e.g., DoE planning and evaluation). In contrast, the algorithm of ZoomLab™ is capable to predict the best suitable formulation concept. Based on the characteristic of an active ingredient, the algorithm of ZoomLab™ can predict prototype formulations for tabletting, heeding special demands e.g., regarding compatibility of the formulation components.
The practical session provides hands-on experience with this tool.
13:00 - Lunch Break
14:00 - Digital Innovation
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Digital tools for product development and manufacture
Facilitator: Matheus de Castro
This session will facilitate discussions on digital tools in product development and manufacturing.
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Accelerating the Implementation of Digital Tools in Chemistry, Manufacturing and Controls in Regulatory Submissions
Speaker: Dr Chantal Mustoe
A digital transformation of pharmaceutical process development and manufacturing is underway, and, to realise the full benefits of this transformation, regulatory innovation is required. At the newly formed Digital CMC Centre for Regulatory Science and Innovation (CERSI), we are accelerating the adoption of digital tools in regulatory submissions. Through collaborative efforts across academia, industry and regulators, we are developing a framework and a sandbox with associated training for digital tools (physics-based, AI/ML and hybrid). These project outputs will enable researchers and regulators alike to assess the regulatory readiness of digital tools in a consistent manner. Our collaborative efforts should reduce the risk of regulatory approval delays cutting time to patient for new medicines.
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ZoomLab® behind the scenes – Algorithm and Model Development (Martin Hofsaess)
Speaker: Martin Hofsaess
Learn about the scientific background of various algorithms and models utilized in ZoomLab including their validation and documentation.
15:00 - Advanced pharmaceutical manufacturing (Troels Pedersen)
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Advanced pharmaceutical manufacturing (Troels Pedersen)
Speaker: Troels Pedersen (GEA)
Advanced manufacturing equipment for high-quality pharmaceutical process development and production solutions will be presented
15:30 - Tooling Strategies to Solve Sticking (Robert Blanchard)
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Tooling Strategies to Solve Sticking (Robert Blanchard)
Speaker: Robert Blanchard (I Holland)
During this session we will detail how I Holland Ltd have developed a predictive model (TSAR) that can predict single particle adhesion of API’s and excipients to its range of PharmaCote anti-stick coating solution. The TSAR (Tableting Science Anti-stick Research) model reduces the need to carry out expensive and detailed compression trials to identify a tooling solution to eradicate sticking. We will also detail the root causes to sticking and how I Holland’s solutions address these issues.
16:00 - Closing remarks
Programme may be subject to change
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