Hands-on Lyophilization Development & Analysis Workshop

2-Day Intensive Laboratory Training | Small Group Format | Certificate of Completion

Overview

This immersive program guides participants through the complete lyophilization process. From formulation and thermal analysis to cycle development, optimization, and troubleshooting, get a hands-on experience in a real working CDMO facility.

Unlike training center environments, attendees work alongside the same team and equipment used in active commercial production.

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Logistics & Enrollment

Course Schedule Highlights

DAY 1

Thermal characterization of simple formulations (freeze-drying microscopy, impedance and MDSC analysis) → formulation filling, loading, and initial cycle programming → evening networking event

DAY 2

Characterization of complex formulations → critical evaluation of lyophilization cake appearance and defect identification → cycle termination and sampling under controlled conditions → MDSC and Karl Fischer analysis of dried samples → facility tour and laboratory equipment demonstration

Monitoring and analysis of completed samples (moisture content, thermal characteristics, mechanical properties) → review of full workshop data and learning outcomes → final Q&A and wrap-up

View full course agenda here:

What You Will Learn:

1. Apply thermal characterization (DSC, impedance analysis) directly to cycle design and understand how to generate and interpret the data required to build a stable lyophilization cycle.
2. Translate analytical data into practical cycle development steps, understanding how freezing, annealing, primary, and secondary drying combine to deliver a reliable and consistent end product.
3. Build and run freeze-drying cycles based on real-time PAT data.
4. Troubleshoot problematic cycles using structured strategies, identifying root causes and implementing effective solutions.
5. Evaluate lyophilization cake appearance and identify defects.
6. Perform post-lyophilization analysis, including moisture content, thermal properties, and mechanical performance.
7. Transfer cycles between lyophilizers and scale up from research to production.

Why Choose This Course?

Real CDMO facility, not a training center

Attendees work in an active commercial CDMO lab gaining exposure to real production workflows, equipment, and the people behind them.

CDMO perspective on cycle development

Instruction is grounded in active commercial contract work and not just equipment operation.

Small group format with dedicated equipment per team

State-of-the-art lab including demonstration of production-scale equipment

Our Carlsbad lab provides hands-on experience with:

• Lyostat 5 Freeze-Drying Microscope
• Lyotherm 3 DTA + Impedance Analyzer
• TA Instruments MDSC

• LyoBeadPRO™ bead generator
• SP Genesis 35EL lyophilizer
• SP AdVantage Pro lyophilizer

Biopharma Technology's Carlsbad, CA facility provides end-to-end CDMO services in lyophilization. Our team of experts, with decades of experience, supports partners in R&D, analytical testing and manufacturing. ISO 9001 and 13485 certified, we deliver practical solutions that improve product quality, efficiency and scalability.

Taught by Lyo Experts

David is now based in California for BTLLC, having rejoined the Biopharma Group in 2013 as a Senior Scientist following experience as a coordinator in the NHS and various analytical laboratories. David was promoted to the senior management team in 2016, having built up significant experience in the freeze-drying industry, providing analytical research, consultancy, alongside product and process development for customers worldwide.

Since then, David has helped expand Biopharma Group’s technical portfolio, leading the growth of the R&D laboratories and assisting the move into diagnostic and GMP compliant pharma production. 

Dave Banks - Chief Technical Officer at Biopharma Technology LLC

Who Should Attend

• Scientists and engineers new to lyophilization seeking structured, hands-on foundational training.
• Experienced lyophilization users looking to deepen their troubleshooting skills and cycle optimization techniques.
• Process development and formulation scientists working on complex drug products.
• Those evaluating or working with CDMOs who want a deeper understanding of the development process.
• Anyone new to lyophilization, or considering using it to stabilize their product, who wants hands-on experience in building a robust lyophilization cycle.
• Professionals already using lyophilization processes who do not yet apply up-to-date thermal analysis or PAT tools to understand their product better and maintain quality and compliance.
• Those experiencing inconsistent results or looking to improve product quality through better cycle design.
• Professionals involved in lyophilization processes, including research scientists, laboratory managers, technicians, and QA/QC specialists.

Additional Content

Prior to the course, we provide access to two 50-minute pre-recorded modules from our introductory lyophilization series, available via our e-learning platform. These modules allow you to build or refresh your foundational knowledge at no additional cost, ensuring you are fully prepared for the hands-on practical training.

Click on the video thumbnail to watch a trailer.

Introduction to Freeze Drying, Freezing and Annealing

Primary and Secondary Drying

Download course brochure

Learn more details here: