An Overview of Biopharmaceutical Manufacturing Processes (T24)

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Training

Level: Intermediate
ISPE CEUs: 1.5
Type: Classroom Training Course
Includes Webinar

Date	Location	Country	Instructor(s)
9-10 October 2013	New Brunswick, New Jersey	USA	Mark Witcher
7-8 October 2013	Prague	Czech Republic	Bruce Williams

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; the basics of biotechnology
Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance
What parameters are important for process validation
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
Process/Facility relationships
Industry trends and future developments in biotech manufacturing processes
The impact of single use systems in bioprocesses
A look at technology transfer

Immediately apply the course learning objectives with the complimentary copy of the ISPE Guide: Biopharmaceutical Manufacturing and Process Development.

Course Modules

Introduction
Biotech Basics
Regulatory & QbD
Culture of Cells & Media
Normal Filtration
Viral Removal
Chromatography
Single use
Facility; Utilities
Scale-up
Tech Transfer

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 one week 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 the relationships between product, process, and facility attributes in biomanufacturing
Understand current regulatory guidance impacting process development and execution
Compare various process aspects of upstream and downstream operations
Understand options available for single use technologies in biomanufacturing

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.

Last Update: 30 May 2013