EAS is partnering with Pharma Webinars (a division of the Tungsten Shield Group) to bring new online professional training to the analytical science community. Our webinars are not pre-recorded but live and interactive. There will be time for questions after the presentation. Group rate available.
Protein Analysis: A Comprehensive Overview of Analytical Testing and Specifications & Latest Regulatory Requirements
This course will provide an overview of:
• Basic biotechnology to facilitate an understanding of the nature of proteins.
• Manufacturing technology for proteins.
• Analytical technologies for characterizing proteins.
• Analytical controls including typical specifications for proteins.
• Regulatory requirements and guidances for proteins.
It has been said that “you cannot control what you cannot measure.” This course is intended to provide an overview of the types of analytical controls available for the manufacture of proteins. Furthermore, the course will provide insight into the underlying technologies used for protein manufacture including both protein expression in various cells and the related purification processes necessary to manufacture drug substance (active pharmaceutical ingredient) and drug products. Because most proteins are sterile injectable products, information will be provided related to the special requirements related to the delivery of sterile injectables. Finally an overview of available regulations and guidance will be provided.
The objective of this live training webinar is to discuss the test method lifecycle and how concepts discussed in the process validation guidance apply to test method validation.
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