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Lyophilization Technology - Application of Scientific Principles

  • Slide title

    “The lyophilization training course has great technical and very informative material to understand the science behind lyophilization process and the potential problems that may occur during production.”


    Ella, QA Manager Gilead Sciences

  • Slide title

    “The Course Director was very personable and was able to tailor the presentation to our specific industry needs.  He is very knowledgeable and made the course fun!”


    Joseph S., Product Specialist, Fluid Air

  • Slide title

    “I really enjoyed the instructor’s use of anecdotes while describing applications of concepts.  Fantastic knowledge and experience to pass on!”


    Eric F., Scientist, Janssen R&D

  • “The instructor had deep knowledge of the field. He shared good examples. The course material was a great starting point to launch discussions relevant to our specific needs. He was very responsive, and the material is useful for both training and for reference."


    Dom D., Abbott Molecular

Course Director

Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

Course Description

This course is designed to provide attendees with a practical approach to understanding the scientific and engineering principles of lyophilization. The topics discussed during the course will be presented to explain the physical, physicochemical, biochemical, and engineering principles of the science and engineering behind modern freeze-drying. The practicality of the course allows the attendees to get a firm understanding of the theoretical applications of freeze-drying and how these can be easily used and applied to their day to day lyophilization projects.

Topics covered will include:



  • History of lyophilization
  • Properties of water and ice
  • Phase behavior during freezing
  • Thermal characterization
  • Annealing
  • Visco-elastic properties of amorphous phases
  • Collapse phenomena
  • Product formulation
  • Heat and mass transfer
  • Cycle development
  • End point determination
  • Residual moisture
  • Process scale-up and sonic water vapor flow
  • Process control and optimization
  • Freeze dryer mechanical and control systems
  • Quality by Design approach to deviation management

Who Should Attend

This 15 hour lyophilization training course is designed for those in the pharmaceutical, biomedical, medical device/diagnostic, and biotechnology industries who develop and/or produce lyophilized (freeze-dried) products. This includes, but is not limited to, professionals in Quality Control, Quality Assurance, Validation, Pharmacists, Managers, Microbiologists, R&D Groups, Biochemists, Pilot Plant Operators, Chemical Engineers, Production Supervisors, Chemists, Equipment Maintenance, and Mechanical Engineers. The course will also benefit those in other departments who find lyophilization among their responsibilities.

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  • Learning Objectives

    Upon completion of this course, attendees will have a clear understanding of both the scientific and practical principles behind the formulation and development of lyophilized products. Additionally, participants will gain a firm understanding of lyophilization equipment including system components, operation, troubleshooting, and validation. This course is presented in a very practical manner, so attendees will be able to quickly apply what they have learned to their lyophilization projects.

  • Agenda


    Section 1: History and background

    • Definition of freeze-drying, history, and commonly freeze-dried materials
    • Desired freeze-dried characteristics
    • Subsystems in the freeze-drying process and phases of the Lyo cycle

    Section 2: Unit operations for freeze-dried pharmaceuticals

    • Formulation
    • Component prep
    • Filling
    • Lyo / capping
    • Inspection
    • Labeling and packaging

    Section 3: 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 4: 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 5: Freeze-Drying equipment

    • Basic components / systems
    • Sequence of operations

    Section 6: Quality product attributes

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

    Section 7: Lyo formulations

    • Excipients for small and large molecules

    Section 8: Container/closure components

    • Vials and stoppers

    Section 9: Instrumentation

    • Temperature and pressure measurements
    • Process Analytical Technology (pressure, moisture, gas flow, TDLAS)

    Section 10: Performance

    • Sources for process control imprecision (variables affecting heat and mass transfer)
    • Measurement of equipment capability
    • Optimization for analytical assessments and for the lyophilization process

    Section 11: Scale up from development to production

    • Dryer correlation
    • Tech transfer
    • Validation
    • Deviation management via Quality by Design

  • Testimonials

    "The Course Director was very personable and was able to tailor the presentation to our specific industry needs. He is very knowledgeable and made the course fun!."

    Joseph S., Product Specialist, Fluid Air


    "I really enjoyed the instructor’s use of anecdotes while describing applications of concepts. Fantastic knowledge and experience to pass on!."

    Eric F., Scientist, Janssen R&D


    "The Course Director had deep knowledge of the field. He shared good examples and the course material was a great starting point to launch discussions relevant to our specific needs. He was very responsive and the material is useful for both training and for reference."

    Dom D.,(Ph.D.) Abbott Moleculars


    "The lyophilization training course has great technical and very informative material to understand the science behind lyophilization process and the potential problems that may occur during production."

    Ella H., QA Manager, Gilead Sciences


    "The Course Director was very knowledgeable and his real life experiences made the course that much better. He knows what he is talking about!"

    Kevin D., Director of Manufacturing, J&J


    "Since I don't operate the machines or design product cycles I came to this course not knowing what to expect. The result of the course and discussions with instructors and attendees has given me the inspiration to become involved with the freeze-drying processes at my company in the future. The discussions not only gave technical information but brought the processes to my level of interest."

    Dan M., Bioreagents Technologist, Instrumentation Laboratory


    "This was a very good review/introduction to lyophilization. I didn't have much background in any of this when I arrived, but now I feel like I can begin to ask the right questions and to focus on our particular application of freeze drying."

    John C., Bioreagent Technologist, Instrumentation Laboratory

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.

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