Cell Culture And Fermentation Processes In The Pharmaceutical Industry - Overview & Advanced Program

Event Information
Product Format
Prerecorded Event
Presenter(s)
Lori Herz, Ph.D.
Length
120 Minutes
Product Description

Understand The Technicalities of How Biologics-Based Products Are Developed, Manufactured, And Regulated In Pharmaceutical Industry.

Biologics-based products are a rapidly growing segment of the pharmaceutical industry and an understanding of how these products are developed, manufactured, and regulated is highly important.

Over the past two decades, many pharmaceutical and biotechnology companies have developed and launched biologics-based products, which have become significant assets in the pipeline and portfolio of these companies and, more importantly, help treat patients in need of these products. As such, a solid understanding of the technical aspects of these processes and the associated equipment has become more important than ever.

This 120-minute session presented by expert speaker Lori Herz, Ph.D , will covers the basics as well as advanced information and knowledge on cell culture and fermentation in the pharmaceutical industry. While the first 60-minute will be devoted to the basics needed to understand the fundamental, yet essential, components of cell culture and fermentation, i.e. upstream biologics processes, in a biopharmaceutical setting, the remaining part of the session will cover topics such as bioreactor design, and the major categories of bioreactor models, applications for each design, as well as common types of agitators and impellers. This will lead into a discussion of the engineering involved in the development and scale-up of upstream processes, including selection of operating parameters and in-process specifications, and a description of models used for power input, as well as heat and oxygen transfer. You'll learn about the approaches to experimental design and quality by design (QBD), strategies for increasing titer, or product formation, at both the genetic and process levels, will be presented. Also you'll learn about the tips for successful technology transfer from R&D to manufacturing, as well as a discussion of the applicable health agency guidelines.

Session highlights

Overview:

  • Overview of products on the market and the cell lines commonly used in the industry
  • Importance of biological products in the pharmaceutical industry
    • Cell types
    • Industry snapshots
  • Culture medium – basic requirements
  • Equipment
    • Essentials for large and small scale processing, culture analysis, storage, and sterility
    • Reactor design fundamentals
  • Sterility and aseptic operation
  • Processing  - basic models for growth, process parameters, & analytical testing
  • FDA Guidelines
  • Development & manufacture of drug substances
  • Read more

Advanced:

  • Reactor design
    • Types
    • Configurations
    • Agitator & impeller design
  • Process development & scale-up – key parameters, power input, Quality by design (QBD)
  • Strategies for cell culture process optimization
  • Tips for successful technology transfer from R&D to manufacturing
  • Regulations & Guidelines
    • ICH Guidelines & Overview
    • FDA Guidelines
    • QBD Approach to Product Development
  • Objectives & Approach : Q8, Q9, Q10
  • Read more

Who should attend?

Process development scientists and engineers, manufacturing engineers, Junior-level scientists and engineers, Process technicians, Production supervisors and managers, Quality assurance and quality control personnel etc. working in Pharma companies & research institutes/universities.

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About Our Speaker

Lori Herz - Pharma Training Expert

Lori Herz, Ph.D. is currently a Professor of Practice of Chemical Engineering at Lehigh University. She is the Associate Director of the Bioengineering Program at Lehigh, where she teaches the Metabolic Engineering and Biotechnology Laboratory courses. Additionally, she is affiliated with the Integrated Product Development program, for which she advises student teams working on their capstone design projects.

Prior to joining Lehigh, Dr. Herz worked at Bristol-Myers Squibb...   More Info
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