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6 Webinar Series on Lyophilization - Webinar

  • ID: 3674312
  • Webinar
  • Region: Global
  • Online Compliance Panel
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This webinar package will cover optimized, scientifically based lyophilization cycle development for pharmaceutical, diagnostic, and food products. It will untangle the thermal properties of products, how they influence freeze-drying, and the analytical techniques used to determine these.

CD/Recorded-How It Works:

- Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
- Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants, as you wish.
- Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
- Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:

- Lyophilization and Stabilization of Proteins, Cells and Viruses
- Materials Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles
- Understanding Freezing, Annealing, Primary and Secondary Drying in the Freeze-Drying Process
- Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles
- Scale Up and Cycle Transfer for Lyophilization Cycles
- Container – Closure Systems for Lyophilized Products

Who will benefit?

These webinar will be beneficial to the following:

- Quality Control Scientists
- Development Scientists
- Production Management
- Quality Assurance
- Companies handling powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods.
Note: Product cover images may vary from those shown
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Webinars included in the Package:

1. Lyophilization and Stabilization of Proteins, Cells and Viruses (Duration: 90 Minutes)

This webinar will cover formulation and process development strategies for stabilizing biologically based pharmaceutical and diagnostic products including proteins, cells, and viruses (live, modified live, attenuated). Understanding the degradation mechanisms and improving stability of these molecules through formulation and processing techniques will be discussed in great detail in addition to covering some of the analytical techniques employed to verify the results.

Objectives of the Presentation:

- Thermal properties of formulated products
- Mechanisms of degradation (chemical and physical)
- Theory of physical stabilization of biologically based products
- Process of choosing the best stabilization agents to use and their effects on the thermal properties
- Analytical techniques used to develop and verify acceptable formulations and processes.

2. Materials Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles (Duration: 90 Minutes)

This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity). Understanding if a crystalline, amorphous, mixed, and or metastable system is present in our products, is critical in developing a sound, stable formulation that can easily be freeze-dried. Choosing excipients based solely on their stability imparting characteristics, without taking into account their thermal properties, can result in disastrous results both in the physical structure of the solids and on the long term stability.

Objectives of the Presentation:

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

3. Understanding Freezing, Annealing, Primary and Secondary Drying in the Freeze-Drying Process (Duration: 60 Minutes)

This seminar will cover the freezing, annealing, primary drying and secondary drying steps of a lyophilization process. As each of these steps can affect both the chemical and physical integrity of freeze-dried products, it is important to thoroughly understand the scientific principles behind each step, and how to apply them when developing an optimized lyophilization cycle. Additionally, understanding these principles and how then affect the product allows the development scientist to better troubleshoot failed products and or cycles.

Objectives of the Presentation:

- Thermal properties of formulated products
- Theory and practice of freezing protocols
- Theory and practice of annealing protocols
- Theory and practice of primary drying protocols
- Theory and practice of secondary drying protocols
- Tying the different steps together into a complete lyophilization process.

4. Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles (Duration: 90 Minutes)

These techniques allow the development scientist to understand not only what types of materials are present, but also the critical temperatures that are associated with these materials (glass transition temperature, eutectic melting temperature, annealing temperature, etc.). Finally, the webinar will conclude with a brief discussion of some of the specialized analytical techniques that can be employed to characterize the lyophilized solids. Understanding the physical properties of the dried solids allows the development scientist to be able to troubleshoot, diagnose, and correct a problematic formulation and or lyophilization cycle.

Objectives of the Presentation:

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

5. Scale Up and Cycle Transfer for Lyophilization Cycles (Duration: 90 Minutes)

Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on development-scale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production freeze-dryers. Without understanding the scientific principles behind scale-up and cycle transfer, many companies will try tweaking the cycle parameters when problems are encountered during scale-up. While this approach may work occasionally, often, it will lead to additional problems such as excessively long cycle times, shattered vials, higher residual moisture content, etc.

Objectives of the Presentation:

- Critical parameters in scale-up and cycle transfer
- Scale-up strategy
- Mapping studies
- Dryer configuration
- Determining and preventing choked flow conditions
- Understanding the differences between development, pilot, and productions dryers
- Proper information gathering (IO, OQ, manufacturer specifications, operator knowledge, etc.)
- Design and execution of a well thought out scale up strategy
- Identifying choked flow conditions, and designing a cycle to prevent choked flow from occurring

6. Container - Closure Systems for Lyophilized Products (Duration: 60 Minutes)

This webinar will cover various container closure systems used for freeze-dried products including vials and stoppers, bulk drying trays, and pre-filled syringes. Various aspects of the types of materials used, the specialized coatings available, and the configuration of the different systems will be discussed in relation to the impact on the products and the lyophilization process.

Objectives of the Presentation:

- Vial types/formulations
- Vial leachables and extractables
- Vials and specialized formulations and coating
- Stopper types/formulations
- Stopper leachables and extractables
- Stopper and specialized formulations and coating
- Prefilled syringes
- Tray drying and specialized trays
- Learning how to identify the different types of vials and stopper for specific needs
- Understanding what types of special formulations and coatings are available and when to consider these
- Choosing a pre-filled syringe and things to consider for long term stability
- Understanding tray drying and specialized containers for bulk freeze-drying
Note: Product cover images may vary from those shown
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  • Jeff Schwegman Jeff Schwegman,
    Founder and Chief Executive Officer ,
    AB BioTechnologies


    Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies where he develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development.

Note: Product cover images may vary from those shown
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