Protein Analysis: A Comprehensive Overview of Analytical Testing and Specifications & Latest Regulatory Requirements (Completed)

Live, Interactive Training Webinar - Eastern Analytical Symposium & Pharma Webinars
Date: Thursday February 19, 2015 Time: 9:30 - 11:30 AM ET (New York Time) (Completed)
Instructor: Robert Johnson Biography>>>

Over the past 30 years biotechnology has revolutionized medicine. This revolution will continue into the future with even more advanced treatments and technology. Many of these medicines will involve proteins, which are the fundamental building blocks of cells and also extensively involved in cell function.

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.

Learning Benefits:
-A basic understanding of types biotechnology products.
-Fundamental knowledge of production technology and purification processes.
-Overview of analytical tools available to control and characterize proteins.
-Insight into regulator expectations and related resources.

Webinar outline and time breakdown:

09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Biotechnology background & protein manufacture,
10:30 AM Break
10:40 AM Protein Process Controls and Characterization,
Regulatory considerations and guidances,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
The course is designed to give an overview of analytical technology in use for the manufacture of therapeutic proteins. It is intended to benefit those seeking to make a transition from other industries into biotechnology related areas. The information will be focused on those who would like to gain a broad overview and foundation. However, all of the following individuals or disciplines will benefit from attending this Webinar::

  • Quality Assurance personnel
  • Senior management
  • Production management
  • Quality management
  • Quality Assurance Product Reviewers
  • Regulators

EAS mission is to provide excellence in science education and professional development to our analytical community. For over 50 years, EAS has offered a variety of opportunities for professional analytical scientists in multiple disciplines to continue with their education and professional training...  Learn More>>>