An Overview of Biopharmaceutical Manufacturing Processes (T24)

Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course
Includes Webinar

Date Location Country Instructor(s)
This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.

Description

This course provides an overview of biotech manufacturing processes used to make biopharmaceuticals. The course surveys commonly used manufacturing processes, including cell culture and fermentation; harvest and recovery; viral removal and inactivation; and purification processes such as tangential flow filtration, centrifugation, and size exclusion and adsorptive chromatography. Course covers the underlying principles of proteins and cells to provide a basic understanding of how and why the processes manufacture therapeutic proteins. These principles are used to explain and provide a basic understanding of the following important topics:

  • Why proteins behave the way they do
  • How the properties of proteins are used to purify them for use as therapeutics
  • How cells are modified and used to produce proteins
  • Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance
  • What parameters are important for process validation, scale-up and scale-down
  • Critical factors for developing a viable commercial manufacturing process
  • What the attributes of a "good biotech process" are for successful manufacturing
  • Tools used to successfully develop biotech processes
  • Industry trends and likely future developments in biotech manufacturing processes
  • Biosimilars and their underlying challenges for commercialization

Course Modules

  • Introduction - what makes biotech different than small molecule therapeutics
  • Proteins - their structure, function, and behavior
  • Cells - structure, function, and how they grow in cultures
  • Bioreactors - how cells grow and produce target proteins
  • Bioreactor and fermentor design and operation
  • Harvesting and recovering proteins from cells
  • Normal and Tangential Flow Filtration (TFF) separations
  • Centrifugation
  • Viral removal and inactivation
  • Chromatography - protein purification
  • Biogenerics/biosimilars - What they are, and their challenges
  • Quiz

Includes Webinar 

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. You will receive information via email on how to access the Webinar two weeks prior to the start of the training event.

Webinar Learning Objectives:

  • Describe the process of developing biopharmaceutical processes for clinical and commercial manufacturing of biotechnology products
  • Discuss the bioprocess development factors that are critical to successful biopharmaceutical product development

Take Back to Your Job

  • Understanding of how and why biotech processes work
  • Appreciation for the challenges of biopharmaceutical manufacturing
  • Understand what the engineers and scientists are talking about
  • Discuss with product and process development details of planning, executing, and discussing the results of process development activities
  • Ability to understand and evaluate bioprocess information
  • Evaluate and compare various process alternatives for manufacturing biotech products

Attendance Suggested For

  • Individuals with a working knowledge of basic biotechnology and GMP principles, responsible for process design, process validation, and equipment design/selection for biopharmaceutical applications.
  • Management, supervisory, and engineering personnel beginning work in biopharmaceutical product development, production operations, quality assurance, and regulatory compliance.
  • Anyone who wants to know how biopharmaceutical manufacturing processes work.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency element Product Development: Formulation, clinical phases and manufacture. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

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