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HomeResearch & DevelopmentLyophilization – Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyo Cycles

Lyophilization – Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyo Cycles

Teachers
J. Jeff Schwegman
Category:
On-Demand Courses/ Research & Development/
Clear
Duration: 90 Minutes
On-demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

The Food and Drug Administration (FDA) is becoming more educated in the practice and science of lyophilization.  As such, they are asking more questions about lyophilization during NDA or ANDA document reviews, site visits to companies producing lyophilized products, etc.  It is now expected by the FDA, that companies developing new formulations and lyophilization cycles must be able to explain, scientifically, why they have chosen each excipient they have added to a formulation, why they are using as much as they have added, what are the critical temperatures of the products (glass transition temperature, Tg’ or eutectic melting temperature, Te), etc.  Companies that cannot produce this type of information run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin.

The topics described in this session will cover all of the aspects of understanding the thermal properties of the formulation (crystalline, amorphous, mixed), the analytical techniques employed to characterize these systems, and how all of this information is used in formulation and lyophilization cycle development.  At the end of the session, the attendee will be able to develop a well-defined process for taking an empirical approach to designing formulations and the lyophilization cycles used to dry them.  By understanding and applying these principles, companies have a much greater chance of getting products approved by the Regulatory agencies than those companies that employ the “trial and error” approach to formulation and lyophilization cycle design.

At the conclusion of this 90-minute session, participants will be able to:

  1. Understand the thermal properties of a formulation (crystalline, amorphous, mixed)
  2. Understand the critical temperatures (Tg’, Te, Tc) of a formulation
  3. Understand different excipients in formulations and how they affect the thermal properties

Attendees will learn:

  1. Crystalline vs. amorphous vs. mixed systems
  2. Eutectic melting, glass transition, and collapse temperatures
  3. Partial collapse vs. meltback
  4. Examples of failed products
  5. Principals of thermal analysis
  6. Thermal analysis equipment and techniques: DSC, DTA, TEA
  7. Freeze-dry microscopy equipment and techniques
  8. Applications of thermal analysis and freeze-dry microscopy techniques for solutions and solids

Who Should Attend

WHO SHOULD ATTEND

This webinar will provide valuable assistance to those companies involved in the development and manufacture of lyophilized pharmaceutical, diagnostic, and food products.  Specifically, those in the following functional areas will find this course particularly useful:

  • Quality Control Scientists
  • Development Scientists
  • Production Management
  • Quality Assurance

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

J. Jeff Schwegman
Founder and CEO of AB BioTechnologies. He also lectures on formulation, stabilization and process development of lyophilized products.
Clear
Duration: 90 Minutes
On-demand
Includes handouts

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