Overview Biopharmaceutical Manufacturing Processes Online Live Training

ISPE Learning Solution - Online Live Training Online Live

Overview

Having the foundational knowledge of the underlying biopharmaceutical science is critical for developing viable biopharmaceutical processes for the clinical and commercial manufacturing of biotechnology products. Explore 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.

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What You Will Learn

  • Develop biopharmaceutical processes for clinical and commercial manufacturing of biotechnology products
  • Identify key operating parameters for each bioprocess unit operation
  • Decide between available options for single-use technologies in biomanufacturing
  • Strengthen the operational relationship between product, process, and facility attributes 
  • Apply regulatory guidance impacting process development and execution

Resources and Activities

ISPE Guide Biopharmaceutical Process Development and Manufacturing

Online Live 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

Who Should Attend

  • 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

Online Live Course Additional Details

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.

Communities of Practice

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


Daily Schedule and Pricing

  • Online Live
    4 - 5 June

    Daily Schedule at a Glance

    Day 1
    0900 – 0915 Login & Registration
    0915 - 0930 Introductions
    0930 - 1045 Course Content & Exercise
    1045 - 1100 Break
    1100 - 1215 Course Content & Exercise
    1215 - 1245 Lunch
    1245 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Questions & Discussions
    All times for this training course date are displayed in EDT.
    Day 2
    0900 Login
    0915 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1145 Course Content & Exercise
    1145 - 1200 Questions & Wrap-up
    All times for this training course date are displayed in EDT.

    Registration Fee

    EARLY

    On or Before 28 May 

    Member US$1,685 
    Nonmember US$1,685   
    Government/Academia US$550
    Student US$90
    LATE

    On or After 29 May

    Member US$1,785   
    Nonmember   US$1,785   
    Government/Academia US$550
    Student US$98

    Mail or Fax Registration

    Not paying by credit card? Use the registration form to pay by mail or by fax.

    Now Your Whole Team Can Participate in an ISPE Online Live Learning Experience

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

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. 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 or by email, ask@ispe.org.


    Instructor

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