Cell Culture And Fermentation Processes In The Pharmaceutical Industry - Overview

Event Information
Product Format
Prerecorded Event
Presenter(s)
Lori Herz, Ph.D.
Length
60 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 important for those new to the field.

Sign up for this 60-minute event presented by expert speaker Lori Herz, Ph.D. who'll provide you the basics needed to understand the fundamental, yet essential, components of cell culture and fermentation, i.e. upstream biologics processes, in a biopharmaceutical setting.

This session will begin with an overview of products on the market and the cell lines commonly used in the industry, and will be followed by a brief description of culture medium development and formulation. The equipment needed to grow and maintain the cultures, from the laboratory to the pilot and commercial scales, as well as basic elements of reactor design will then be discussed. Emphasis will be placed upon the importance of aseptic operation, including personnel technique and equipment usage. Next, basic mathematical models commonly used to describe cell growth and product formation will be presented with practical examples.  Methods for analysis of cultures, including both in-process and off-line testing, will be discussed to provide an understanding of parameters needed for process development and for successful manufacture in a clinical and commercial setting.  Lastly, highlights of regulatory guidelines applicable to upstream biologics processes will be covered.

Our speaker will provide you the PowerPoint slides of presentation, and walk you through the practical examples – how to apply process models, including step-by-step calculations etc. Also, you'll get references for additional information on topics presented.

Agenda of the Session:

  • Overview of products on the market and the cell lines commonly used in the industry.
  • Typical cell types in biopharmaceuticals
  • Culture medium
  • Equipment
    • Key items
    • Elements of reactor design
    • Aseptic operation
  • Basic models for growth and product formation
  • Process parameters and analytical testing
  • Fermentation / cell culture - Microbial vs mammalian
  • Recombinant proteins in approved biopharmaceuticals
  • Indications of approved biopharmaceuticals
  • Additional types of products produced via biological processes
  • Biologics Manufacture : Cell Culture, Purify protein, Fill & finish
  • Insights on: Culture medium, Cell composition, Culture media requirements, Classes of media for cell culture, Serum-free media.
  • Requirements: Equipment & Incubators.
  • Small & Large scale propagation in fermenters & bioreactors
  • Types of vessels & Mechanical agitation
  • Aseptic / Sterile Processing.
  • 4 Biosafety levels (BSL) - BSL-1, BSL-2, BSL-3 & BSL-4
  • Basic models for growth and product formation
  • CQA/CPP & Process parameters
  • Regulations & guidelines: starting points
  • International Conference on Harmonisation :
    • Overview
    • Q7:GMP Guide for API
    • Q8: Pharmaceutical Development
    • Q11 Highlights
  • FDA Guidelines
  • Development & manufacture of drug substances.
  • Importance of biological products in the pharmaceutical industry
  • And Much More...

Who should attend? 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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