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 products for successful freeze-drying
- Analytical tools used to aid in the formulation and cycle development
Agenda
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
- 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
- Freezing (with optional annealing)
- Primary drying (sublimation of water vapor)
- Secondary drying (diffusion and evaporation of water that did not freeze as ice)
- Excipients for small and large molecules
- General and specific to freeze-dried products
- Influence of collapse and eutectic melting
Speakers
Lisa Hardwick Thompson,
Pharmaceutical Lyophilization Expert ,
Lyo Blackboard LLCLisa 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.
Who Should Attend
- 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.
