Overview Biotechnology Manufacturing Processes Training Course

An Overview of Biopharmaceutical Manufacturing Processes (T24) - Updated!

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

Includes Webinar

This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion and adsorptive chromatography. Course topics include:

Biotechnology basics

  • 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
  • The attributes of a "good biotech process" for successful manufacturing
  • Process/Facility relationships
  • The impact of single use systems in bioprocesses

Additional content will focus on a review of current regulatory guidance impacting process development and execution.

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Immediately apply the course learning objectives with the electronic download of the ISPE Guide: Biopharmaceutical Process Development and Manufacturing you'll receive by attending this course.

Course Modules

  • Introduction
  • Biotech Basics
  • Regulatory & QbD
  • Culture of Cells & Media
  • Filtration processes
  • Viral Removal and Inactivation
  • Chromatography
  • Single use
  • Facility and Utilities
  • Scale-up

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 and an understanding of 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
  • 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).

  • 13 December 2018 - 14 December 2018
    Huntington Beach, CA United States

    Daily Schedule

    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

    Instructors

    Placeholder Person Graphic
    Principal Engineer
    Commissioning Agents Inc

    Fees

    Type
    Early
    Before
    9 Oct
    Regular
    9 Oct -
    31 Oct
    Late
    After
    31 Oct
    Member US$
    1,735.00
    US$
    1,835.00
    US$
    1,935.00
    Nonmember US$
    2,130.00
    US$
    2,230.00
    US$
    2,330.00
    Government US$
    800.00
    US$
    800.00
    US$
    800.00

    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.