Overview

This course is designed  ensure that employees of biopharmaceutical manufacturers who are working in upstream processing, have clear understandings of and technical acumen for aseptic cell culture and scale up. We prepare participants to work effectively in upstream bioprocessing suites which includes maintenance and monitoring of aseptic environments while culturing mammalian cells.


Who should attend this course?

Individuals working in the Biomanufacturing industry including roles such as Upstream Technician, Quality Assurance, Quality Control, Bioprocess Engineers


What are the course's objectives?

  • Participants will gain knowledge in methodologies and principles that underlie mammalian cell culture and aseptic upstream processing.

  • Understand techniques for growing and maintaining anchorage dependent and suspension cell lines.

  • Understand critical parameters involved in aseptic mammalian cell culture within various cell culture vessels including 2 L bioreactors.

  • Understand and integrate cell culture methodologies and techniques with performance indicators in order to optimize individual proficiencies.

Instructor(s)

Our courses are developed by content experts
with years of experience in delivering online eduction

Coordinator of Training

Beth Zielinski-Habershaw, Ph.D.

Dr. Zielinski-Habershaw has extensive biopharmaceutical experience in both academia and the private sector, covering all aspects of the biopharmaceutical and biomedical industry. She came to the PDI in 2019 after a two-year stint in business development at Advanced BioScience Laboratories in Rockville, MD. This is her second stint with the University of Rhode Island, having previously served as Co-Director of Biotechnology Manufacturing at the university. She has also served as a Director with the Center for Biological Engineering at Brown University, a Contract MSL with Medtronic Endovascular in California, and a Medical Writer with CRBard, Inc. in Warwick. Dr. Zielinski-Habershaw’s varied experience is a valuable benefit to the industry partners she works with as Coordinator of Training for the PDI.

How do you want to learn?

We have the solution that best meets your needs.

  • Fully Online

    Through this online learning platform.

  • Onsite

    Lecture & Lab at our facility in Kingston, RI.

Onsite

Learn hands on in a real GMP facility

This onsite course is delivered through a combination of a classroom presentation and hands on activities.

Preparation for the onsite learning is provided through the same self-paced content provided in our fully online course. Completion of this component of this course is necessary to participate in the onsite component. A full outline of the self-paced curriculum can be found at the bottom of this page.

A certificate of completion will be issued by the PDI when all components of the course are completed.


The onsite component of this course lasts for 5 hours, 3 of which are spent in the GMP lab facility.


Due to COVID-19 restrictions this course delivery option is currently not available.

Register your interest now to receive a notice with a $50 coupon when the course becomes available.


*Group discounts are available for all of our courses. Learn More



Fully Online

Learn at your own pace in your own place


This fully online course is delivered through this learning platform by a combination of video presentations, readings and quizzes. A full outline of the self-paced content can be found at the bottom of this page.

A certificate of completion will be issued by the PDI when all components of the course are completed.


There is approximately 5 hours of content in this course.  


$149*

After completing this course you will have the option to purchase the onsite course and receive the full price of this course off the cost of the onsite course.

The purchase must be made within 12 months of completing the online course.



*Group discounts are available for all of our course. Learn More



Self-Paced Content


Content Outline

  • 1

    Before you begin

    • How to use our platform
  • 2

    Course Overview

    • Introduction

    • Instructor: Beth Zielinski-Habershaw, Ph.D.

    • What will this course provide?

    • After this course you will

    • Definitions

    • Course Hand Out
  • 3

    Module 1: Introduction to Pharmaceuticals and Biopharmaceuticals

    • Presentation

    • Review Quiz
  • 4

    Module 2: Who Develops the Guidelines for Aseptic Practices in the Food and Drug Industries?

    • Presentation

    • Review Quiz
  • 5

    Module 3: From Gene Modification to Working Cell Bank

    • Presentation

    • Review Quiz
  • 6

    Module 4: The Clean Room Environment

    • Presentation

    • Review Quiz
  • 7

    Module 5: Non-Viable and Viable Particulate Monitoring

    • Presentation

    • Review Quiz
  • 8

    Module 6: Laminar Flow Hoods and Biosafety Cabinets

    • Presentation

    • Review Quiz
  • 9

    Module 7: Media Prep and Cell Inoculation

    • Presentation

    • Review Quiz
  • 10

    Module 8: Cell Scale Up and Cell Harvest

    • Presentation

    • Review Quiz