Lyophilization Technology
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Who Should Attend
This course is designed for personnel in the pharmaceutical,
diagnostic, biomedical engineering and biotechnology
industries responsible for the specification, development and
production of lyophilized products, including:-
Biochemists
- R&D Personnel
- Chemists
- Pilot Plant Operations
- Chemical Engineers
- Production Supervisors
- Microbiologists
- Managers
- Pharmacists
- QA/QC
Those new to the industry and as well as those with previous
experience will find the course beneficial.
Description
This course is designed to provide participants with an up-todate
understanding of the theory and practice of lyophilization.
Freeze-drying (lyophilization) will be presented and explained
in physical, physicochemical, biochemical and engineering
terms. Theory and practice will be interrelated and
biotechnological and pharmaceutical applications will be
emphasized. Participants should acquire a comprehension
that transcends common disciplinary boundaries.
Topics covered will include vacuum physics, properties of
water and ice, supercooling and supersaturation, phase
behavior during freezing, differential thermal analysis, electrical
resistance, glassy state behavior, collapse phenomena,
desorption phenomena, product formulation, heat and mass
transfer, development of freeze-drying cycles, end point
determination, residual moisture, product stability, process
scale-up, process control and optimization, Current Good
Manufacturing Practice (cGMP), and validation. Fault finding
and problem solving will be presented using case studies.
Other Courses of Interest
Assay Development and Validation for Biopharmaceuticals
cGMP and Quality Issues for Biopharmaceuticals
Drug Product Stability and Shelf-Life
Dec 15 2008, Amsterdam, The Netherlands
Drug Product Stability and Shelf-Life
May 25 2009, Dublin, Ireland
Lyophilization 101: Principles, Physical Properties and Characterization Techniques
Lyophilization: Optimized Pre-Formulation, Formulation, and Cycle Development Techniques
Sterile Products: Formulation, Manufacture and Quality Assurance
Mar 16 2009, Amsterdam, The Netherlands
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