Lesson 3: Downstream Biomanufacturing a

Introduction

Students will conduct a lab exercise that will introduce them to some important unit operations in downstream biomanufacturing.

Activity 1:	Review Downstream biomanufacturing using the Power Point provided. A student crossword puzzle that reviews the terms from the Power Point is included.
Activity 2:	Lab: Simulating Cell Separation in the Downstream Manufacturing Process

Background

The downstream portion of a biomanufacturing process is responsible for removing cells and impurities to produce the final end product that will be made available to consumers. Microbes (such as yeast and e.oli) that are used in biomanufacturing can make products (like insulin) within their cells, this is known as intracellular production. Sometimes, the microbes secrete the products (such as enzymes) and this is called extracellular production. For the purposes of this activity, we are going to simulate extracellular production and assume that our yeast cells secreted a protein product into our bioreactors. The downstream process involves separating these cells from the product (and other soluble impurities) through a filtration process. After cell separation, the filtrate containing the protein is purified using a more sophisticated process like ultra-filtration and/or chromatography. The product is then formulated, filled and prepared for packaging. Depending on the stability of the protein, it may be sold as a liquid concentrate, a dried powder, or made into a tablet, gel or cream. Students will be creating a filtration apparatus for the remaining broth in their bioreactors to study the critical parameters of a filtration process. The Quality Control group in a biomanufacturing facility tests the product after it has been recovered in order to determine the level of concentration or activity. Students will test their recovered product and use a standard curve to determine the product concentration. The process yield will also be calculated:

% yield for filtration =	(concentration of filtrate X volume of filtrate)
	(concentration of broth X volume of broth)

Learning Objectives

North Carolina Standard Course of Study (NCSCOS):

Competencies and Objectives from Exploring Biotechnology

• EB 3.01 Analyze the use of equipment and materials and apply rules for safety in the laboratory.
• EB07.01 Discuss industrial and environmental biotechnology.
• EB07.02 Analyze components of industrial biotechnology.
• EB10.01 Describe careers in Biotechnology
• EB10.02 Discuss bioinformatics and biomanufacturing careers.

Competencies and Objectives from 8th Grade Science

• 1.04 Analyze variables in scientific investigations
• 1.05 Analyze evidence to: Explain observations. Make inferences and predictions. Develop the relationship between evidence and explanation.
• 1.06 Use mathematics to gather, organize, and present quantitative data resulting from scientific investigations: Measurement, Analysis of data, Graphing

Classroom Time Required

This lesson will take two, forty five minute class periods. Introduce vocabulary and review procedures day one and complete the hands-on laboratory exercise day two.

Materials needed

The activity contains a chart of the materials that are needed.

Pre-activities

Review vocabulary using the Power Point provided. The teacher may wish to demonstrate the proper assembly of the filtration apparatus.

Modifications

If lab equipment and supplies are limited, the teacher may wish to conduct the experiment as a classroom demonstration.

File Links for support material

Activity 3-1:	Class Review: Simulating Cell Separation in the Downstream Manufacturing Process Power Point Class Review: Simulating Cell Separation in the Downstream Manufacturing Process Crossword Vocabulary Review
Activity 3-2:	Lab: Downstream Biomanufacturing and Cell Separation Standard Operating Procedure Lab: Downstream Biomanufacturing and Cell Separation Student Batch Record