Lyophilization Technology - Application of Scientific Principles

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    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

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    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

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    “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

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    “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

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Course Director

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Course Fee

$2150.00 Regular Registration

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

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Course Brochure

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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 and applicability of lyophilization
  • Physical and chemical properties of water and ice
  • Phase behavior during freezing, and application of annealing
  • Thermal characterization
  • Visco-elastic properties of amorphous phases
  • Quality product attributes, including impact of collapse phenomena
  • Product formulation
  • Rate processes -heat and mass transfer
  • Cycle development – phases, end point determination, and troubleshooting
  • Application of Process Analytical Technology (PAT) and Quality by Design (QbD)
  • Residual moisture – importance and control
  • Process scale-up, including sonic water vapor flow
  • Container/closure components
  • Process control and optimization, including design space utilization
  • Freeze dryer mechanical/control systems and instrumentation 
  • Deviation management
  • Validation life cycle management of a freeze-dried pharma product

Who Should Attend

This 15-hour lyophilization course is designed primarily for those in the pharmaceutical, biomedical, medical device/diagnostic, and biotechnology industries who develop and/or produce products by lyophilizing (freeze-drying) liquid products in glass vials. 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 pharma 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: Freeze-Drying equipment

    • Basic components / systems
    • Sequence of operations

    Section 4: 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 5: 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 6: Lyo formulations

    • Excipients for small and large molecules

    Section 7: Quality product attributes

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

    Section 8: Instrumentation

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

    Section 9: 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 10: Container/closure components

    • Vials and stoppers

    Section 11: Scale up, Validation, Deviations

    • Dryer correlation
    • Tech transfer
    • Validation – life cycle management and Quality by Design
    • Deviation management 

    Section 12: Workshop

    • Designing a lyo cycle to use for a new drug product

  • Testimonials

    "I learned a great deal from this course and rate it very highly."

    Hong D., Pharmaceutical Scientist, FDA


    "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.