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)
-
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)
-
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
-
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.
-
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.
-
Facilitator: Sunny Singh (Sotax)
This interactive demonstration will show case the use of a SOTAX ST50, semi-automated hardness and dimensions tester. Robust and easy-to-use, the compact multi-parameter tester ensures high-precision results and increases lab efficiency. Also demonstrated will be a SOTAX DT50, bathless disintegration tester with automatic end-point detection, short heating times, and continuous temperature measuring. The modular design allows to add up to 3 additional testing stations anytime; a SOTAX FT2, single or dual drum tester with calculation of percent friability / weight loss will also be available. External analytical balance may be connected to automatically transfer weight readings. With applications from R&D, IPC to QC, automation and data integrity can be achieved with the use of q-doc software.
-
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.
-
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)
-
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
-
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.
-
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.
-
Facilitator: Sunny Singh
Tablet dissolution testing is an essential process in the pharmaceutical industry, used to assess how a tablet breaks down and releases its active ingredients in a controlled environment. This workshop will show case equipment commonly used to perform these dissolution tests.
-
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.
-
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)
-
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)
-
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
-
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.
-
Facilitator: Sunny Singh (Sotax)
This session will offer valuable insights into the latest advancements in tablet characterization automation, along with tailored solutions to meet industrial needs.
-
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 - This session will facilitate discussions with industry representatives on the regulatory acceptance of digital tools in product development and manufacturing
-
15:00 - 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)
-
16:00 - Closing remarks
Programme may be subject to change
Back to Tabletting School 2025