2014 Sept Training
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Overview Biotechnology Manufacturing Processes Training Course

An Overview of Biopharmaceutical Manufacturing Processes (T24)

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

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
Biopharmaceutical Process Guide Cover

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

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).

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DatesLocationsInstructors 
03 Apr 2017 -
04 Apr 2017
Tampa, FL USA Speaker TBD
Register

Fees and Daily Schedule

TypeOn or Before
04 March
After
04 March
Member US$1,735 US$1,935
Nonmember US$2,125 US$2,325
Government US$955 US$1,065
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break
DatesLocationsInstructors 
08 May 2017 -
09 May 2017
Copenhagen, Denmark Speaker TBD
Register

Fees and Daily Schedule

TypeOn or Before
08 April
After
08 April
Nonmember €0 €0
Daily Schedule at a Glance
08.00 – 17.00 Registration Open
09.00 – 17.00 Training Course
10.30 – 11.00 Refreshment Break
12.30 – 13.30 Lunch
15.00 – 15.30 Refreshment Break
DatesLocationsInstructors 
02 Oct 2017 -
03 Oct 2017
Tampa, FL USA Speaker TBD
Register

Fees and Daily Schedule

TypeOn or Before
02 September
After
02 September
Member US$1,735 US$1,935
Nonmember US$2,125 US$2,325
Government US$955 US$1,065
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time; only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

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