Advanced Lyophilisation Formulation to Post-Process Analysis

3-Day Workshop | Formulation and Process Decisions for Freeze Drying Success

Overview

This new course provides a comprehensive and practical exploration of freeze drying for pharmaceutical and biotechnology applications. It addresses the full end-to-end development process, from understanding formulation behaviour in the frozen state through to the design, execution, and evaluation of robust freeze drying cycles.

Combining foundational theory, hands-on experimentation, and real-world case studies, the course bridges the gap between scientific principles and industrial application, with an emphasis on troubleshooting and scale-up challenges.

Course Details

A key focus of this workshop is experiential learning. Participants will gain practical, hands-on experience with industry-relevant techniques, including:

Formulation Characterisation

• Freeze-drying microscopy (FDM)
• Thermal analysis
• Impedance analysis

Freeze-Drying Process Execution

• Running freeze-drying cycles using model formulations
• Monitoring and controlling critical process parameters

Post-Process Product Evaluation

• Product appearance and structure
• Residual moisture determination
• Glass transition temperature assessment
• Thermostability
• Reconstitution behaviour
• Mechanical properties

These activities are directly linked to cycle development and quality-by-design principles.

Additional Learning Materials

Our lyophilisation e-learning modules cover topics such as:

• Module 1: Introduction to Lyophilization & Freezing and Annealing
• Module 2: Primary and Secondary Drying
• Module 3: Formulation Fundamentals & Formulation Characterisation
• Module 4: Cycle Development & Process Analytical Technology
• Module 5: Scale-up Factors & Analysing the Final Product

By the end of the workshop, attendees will be able to:

• Interpret frozen-state and thermal analysis data to inform formulation and process decisions

• Design freeze-drying cycles from first principles using a structured, science-based approach

• Apply process analytical tools to monitor and control critical parameters during drying

• Evaluate post-process product quality, including residual moisture and glass transition temperature

• Diagnose and resolve common formulation and process failures using practical case-study insights

• Translate laboratory-scale understanding into strategies that support scale-up and technology transfer

This workshop is designed for scientists and engineers working in:

• Pharmaceutical, biotechnology, and diagnostic R&D laboratories
• Commercial manufacturing and production facilities
• Academic research laboratories
• Formulation development, process development, analytical science, and technical transfer roles

The course is suitable for both experienced practitioners seeking deeper practical insight and those looking to translate theoretical knowledge into real-world lyophilisation development.

1) Formulation development for freeze-drying

2) Understanding formulation behaviour in the frozen state

3) Designing freeze-drying cycles with scale-up and technology transfer considerations

4) Pre-process, in-process, and post-process analytical techniques

5) Monitoring and controlling critical process parameters

6) Industrial case studies and troubleshooting common failures

During this workshop, participants will:

• Learn the practical realities of formulation and process development, including common challenges and how to address them
• Gain a comprehensive understanding of the fundamental principles of freeze-drying technology through structured learning and expert-led discussion
• Apply theoretical knowledge to the practical development of freeze-drying formulations and cycles
• Understand how to design efficient, robust freeze-drying recipes suitable for scale-up and manufacturing transfer
• Build confidence in interpreting analytical data and making sound development decisions

Dr. Bhaskar Pandya

Senior Scientist, Biopharma Group

Bhaskar joined Biopharma Group in 2021 as a Senior Scientist after earning a PhD on single-vial freeze drying monitoring using vial impedance spectroscopy (TVIS) at De Montfort University, UK. At Biopharma's Winchester lab, Bhaskar manages collaborative pharma and diagnostics projects and provides consultancy for new and existing products. He also holds a Master’s by Research (MRes) from University College London, enhancing his expertise in the field.

Mervyn Middleton

Senior Scientist, Biopharma Group

After earning a BSc (Hons) in Biochemistry from the University of Portsmouth in 2009, Mervyn joined Biopharma Group where he worked through to 2015, gaining expertise in product analysis and lyo cycle development. Returning in 2021 as a Senior Scientist, Mervyn has worked on over 50 projects, including pre-lyophilised and lyophilised product characterisation, formulation development, freeze drying cycle optimisation, process auditing, and consultancy across all stages of lyo development and scale-up.

Book Your Spot Today!

Price: £3,500 (ex. VAT)

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