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

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

Understand Designs, Applications, And Process Development Methodologies To Develop And Launch Biologics-Based Products!

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, an in-depth understanding of approaches to producing these drugs competitively and efficiently, with a solid understanding of the technical aspects of these processes and the associated equipment, has become more important than ever.

Join now for this 60-minute session presented by expert speaker Lori Herz, Ph.D who will enlighten you on 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.

Our speaker will share PowerPoint slides of the presentation, and discuss practical examples of process development methodologies. You'll also be provided with the references for additional information on topics presented.

Here's a look at what all will be covered:

  • Reactor design 
    • Types
    • Configurations
    • Agitator & impeller design
  • Process development & scale-up
    • Key parameters
    • Power input
    • Heat & oxygen transfer
    • Heating & cooling requirements in a fermentor
    •   Quality by design (QBD)
    • Process scale-up
    • Power input : Bulk mixing time, P/V, Impeller tip speed, Gas flow rates
  • Strategies for cell culture process optimization :
    • Cellular engineering
    • Feed optimization
    • Environmental parameters
    • Process monitoring & controls
    • Fed-batch case study
  • Regulations & Guidelines :
    • ICH Guidelines & Overview
    • FDA Guidelines
    • QBD Approach to Product Development
  • Objectives & Approach : Q8, Q9, Q10
    • Quality by design
    • Design space
    • Risk
    • Risk assessment
    • Quality risk management
    • Pharmaceutical Quality Systems
    • Case Study to advance Q8, Q9, Q10
    • Results: Process performance and product quality
    • Risk assessment approach
  • Development and scale-up of upstream processes
  • Selection of operating parameters and in-process specifications
  • Description of models used for power input
  • Elements of technology transfer
  • Tips for successful technology transfer from R&D to manufacturing
  • Strategies for increasing titer, or product formation, at both the genetic and process levels.
  • Discussion of the applicable health agency guidelines.
  • Detailed Insights for Manufacturing engineers, Production supervisors and managers & Quality assurance and quality control leaders.
  • And much more...

Who should attend? Process development scientists and engineers, manufacturing engineers, production supervisors and managers, quality assurance and quality control leaders.

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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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