Example Curriculum

  Training Agenda Lyophilization Basics for Pharmaceuticals: History, Scientific Principles, Cycles and Formulations
Available in days
days after you enroll

Choose a Purchase Option

Training Overview

This course will act as an introduction to freeze-drying of pharmaceutical parenteral products. Many drug substances require the extra protection that lyophilization provides, and the formulation of the liquid drug product must be designed to optimize efficacy of the finished dried product. The course will cover how lyophilization works to convert a liquid drug product into a dried, more-stable powder. Cycle and formulation design will be explained, along with the scientific principles that are at play.

Why Should You Attend

To learn the how and why for formulating and designing lyophilization cycles for drugs that will benefit from the freeze-drying process

Learning Objectives

  • Definition of freeze-drying
  • Identify ideal characteristics of a freeze-dried product
  • Determine when freeze-drying is necessary
  • Phases of the lyo cycle, and the scientific principles that drive each phase
  • Formulating drug product for successful freeze-drying
  • Analytical tools used to aid in formulation and cycle development


Section 1: History and background

  • Definition of freeze-drying, history, and commonly freeze-dried materials
  • Desired freeze-dried characteristics
  • Advantages and limitations of freeze-drying
  • Process overview

Section 2: Physical, chemical, and engineering principles

  • Vapor pressure
  • Sublimation and the phase diagram of water
  • The heat of sublimation of ice
  • Rate processes in freeze drying – heat transfer and mass transfer
  • States of matter – crystalline and amorphous

Section 3: Lyo cycle phases

  • Freezing (with optional annealing)
  • Primary drying (sublimation of water vapor)
  • Secondary drying (diffusion and evaporation of water that did not freeze as ice)

Section 4: Lyo formulations

  • Excipients for small and large molecules

Section 5: Quality product attributes

  • General and specific to freeze-dried products
  • Influence of collapse and eutectic melting

Who Will Benefit

  • Professionals in Quality Control
  • Quality Assurance
  • Validation
  • R&D Groups
  • Biochemists, Pilot Plant Operators
  • Chemical Engineers
  • Production Supervisors
  • Chemists
  • Equipment Maintenance
  • Mechanical Engineers

The course will also benefit those in other departments who find lyophilization among their responsibilities.

Pharma Faculty Lisa Hardwick Thompson

Lisa Hardwick Thompson 

Pharmaceutical Lyophilization Expert at Lyo Blackboard LLC

Nashville, Indiana, United States

Lisa Hardwick Thompson is a pharmaceutical technology consultant and educator with quality, regulatory, product/process development, and technical management experience at Cook Medical, Baxter, Catalent, and start-up businesses. During her career based in the pharmaceutical CMO sector, her expertise has been dedicated to the creation and/or transfer of clinical and commercial formulations and processes, specifically focused on lyophilized parenteral drug products. Her current role at Lyo Blackboard is devoted to consultation and education in the field of lyophilization.

Our Participants Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals