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Industrial Lyophilization Training

INDUSTRIAL LYOPHILIZATION TRAINING (virtual)

Dates:

  • February 8-10, 2021

Location (virtual):

  • UMass Lowell, Lowell, Mass.

Course Description:

  • This course teaches best practices in the design of lyophilization processes for biopharmaceutical products and formulations. The course describes pitfalls to avoid when designing lyophilization processes, and ways to increase efficiency and effectiveness known only to top lyophilization experts.

Instructors:

  • Dr. Muhammad Ashraf (FDA), Seongkyu Yoon, Ph.D. (UMass Lowell), Akhilesh Bhambhani, Ph.D. (Merck), Robin Bogner, Ph.D. (UConn), William Kessler (Physical Sciences Inc.).

Target Audience

  • Senior Research Scientist, Bioprocess Engineer, or equivalent in Pharmaceuticals, Biopharmaceuticals

Objective

  • Describe the fundamental processes involved in lyophilization
  • Summarize the major considerations involved in formulation design relevant to biologics and their impact on drug product
  • Describe the process analytical technology used in lyophilization
  • Describe the critical quality attributes of lyophilized products and their measurement
  • Summarize the major considerations involved in process design and their impacts on the drug product
  • Describe some common pitfalls in vial filling in a manufacturing setting

Modules

  • M1. Introduction to lyophilization
  • M2. Formulation Development and Characterization
  • M3. CQAs of Lyophilized Products
  • M4. Tour of LyoBay
  • M5. Preparation of test vials; stoppers, sterility concerns, etc.
  • M6. Initiating lyophilizer cycle
  • M7. PAT in lyophilization
  • M8. Lyophilization process design
  • M9. Evaluation of cakes; residual moisture; pore structure; specific surface area
  • M10. Collection of vials and collection of relevant data
  • M11. Data analysis
  • M12. Process scale-up

Registration

The cost of attendance is $2,500; 50% discount for academic and government.

Industrial Lyophilization Training Online Registration

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