Freeze Drying for Biologics/Pharmaceutics

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Freeze Drying for Biologics/Pharmaceutics

Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer

Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation

Course description

With the rise of biologics and new types of biotechnological drugs, which are usually very sensitive and unstable, reliable freeze drying in Pharma & Biotech is becoming more important than ever.

Freeze-drying is considered a delicate drying process. However, it can cause numerous stresses that induce chemical and physical instabilities. Subsequently, the inclusion of suitable excipients along with optimizing the process parameters is crucial to attain stable lyophilizates with high-quality attributes. It is also a high-cost technology with a substantial environmental footprint, so process optimisation is an important consideration.

This practical course will focus on the freeze-drying process from formulation and thermal analysis to cycle development and optimization, packaging and troubleshooting.

Join us and master the complexities & new challenges of lyophilization process to ensure that life-saving medications remain stable, potent, and safe for patient use.

meet the training leaders
Paul Matejtschuk BSc PhD CChem FRSC
Honorary Professor in the Leicester School of Pharmacy
Geoff Smith
Professor of Pharmaceutical Process Analytical Technology at Leicester School of Pharmacy
De Montfort University, UK
Jakob Trenk
Technical Sales Manager, Freeze Drying Expert
OPTIMA pharma, Germany
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Freeze Drying For Biologics Pharmaceutics Training Course organized by Fleming_agenda cover
Freeze Drying for Biologics Pharmaceutics training organized by Fleming_Agenda Cover
Freeze Drying For Biologics Pharmaceutics Training Course organized by Fleming_agenda_3
key training

Topics

Freeze drying process overview

Using thermal properties to derive freeze drying parameters

Freezing, primary & secondary drying

Formulation design & new modalities

Container formats & their impact

Pharmaceutical Freeze-Drying Equipment

Quality control, testing & troubleshooting

Benefits of attending

Testimonials

Registration

Training ticket

If you are interested in a Site Visit, please include the information in the note during the registration process.

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FAQs – Freeze Drying for Biologics/Pharmaceutics

You will explore freeze drying from fundamentals to formulation, thermal analysis, cycle development, optimisation, packaging and troubleshooting, with a practical focus on biologics and pharmaceutical products. The training is designed to help participants connect scientific understanding with real process decisions and product quality outcomes.

The course reviews freezing, sublimation, primary drying and secondary drying, including how process parameters relate to product quality and performance. Participants gain a clearer framework for approaching cycle development and optimisation in practical pharmaceutical and biopharma settings.

Thermal analysis is covered as a key step for characterising frozen and dried states and determining critical product temperatures before freeze drying. This helps participants understand how formulation behaviour can guide more informed process choices and reduce avoidable development uncertainty.

Yes, the agenda includes determination of critical temperatures, freeze drying microscopy, Differential Scanning Calorimetry, dielectrics and impedance. These topics are positioned to help attendees understand how product characterisation supports freeze drying parameters and cycle decisions.

The programme covers sublimation, heat and mass transfer, container impact, spatial distribution of Kv, and monitoring techniques for identifying the end of primary drying. This gives participants practical insight into one of the most important stages of lyophilization process optimisation.

Yes, the Process Analytical Technology session includes pressure-based methods, thermocouples, wireless probes, IR sensors, manometric temperature measurement and Through-Vial Impedance Spectroscopy. Participants will see how monitoring approaches can support better understanding of freeze drying performance.

The formulation session covers stabilisers, bulking agents, dry mass and balancing formulation with process considerations. It also refers to examples across small molecules, biopharma and vaccines, making the topic relevant for both development scientists and manufacturing-focused teams.

The equipment session reviews specifications, key process parameters, main system components, functional elements, and layout considerations for GMP production. This is especially useful for professionals involved in technical decisions, production planning, sterile manufacturing or equipment-related process discussions.

The Quality Control session covers Critical Quality Attributes, moisture measurement, activity measurement, and common freeze drying failures with their causes. Attendees can expect a practical view of how quality, testing and troubleshooting connect to real lyophilized product performance.

Yes, the course objectives include scale-up, pharmaceutical-grade manufacturing, process economics, energy requirements and thermodynamics. The programme also highlights process optimisation as important because freeze drying is a high-cost technology with a substantial environmental footprint.

The invitation-only site visit gives participants practical exposure through rotating stations covering materials science and production, mechanical freeze dryer equipment, freeze drying process engineering, and open expert stations with experts and suppliers, helping attendees connect classroom topics with real-world observations and practical insights.

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