Great Bay Community College

Course Content Outline

Course Number: / BTEC 220 / Course Title: / Biotechnology Experience II: Biomanufacturing
Department: / Life Sciences and Chemistry / Date Prepared: / October 4, 2012
Program: / Biotechnology / Prepared by: / Deb Audino
Theory Hours: / 2 / Lab Hours: / 6
Credits: / 4
Prerequisites: / C- or better in BTEC 210
Exceptions by permission of department chair only / Corequisites:

Catalog Description

Biotech Experience II: Biomanufacturing / Course Number BTEC 220. The second of two experiential, cornerstone courses in Biotechnology. The course begins by introducing the student to the proteins and companies of biotechnology and to cGMP or current good manufacturing practices. In the remainder of the course students use bacteria, mammalian, and yeast cells to produce two human proteins using tools and manufacturing standard operating procedures of biotechnology, including upstream and downstream processing of proteins and quality control of protein production. Lectures provide the knowledge base of biotechnology manufacturing.

Course Objectives:

1. To understand the role of biomanufacturing in the healthcare industry.

2. To understand the various job opportunities in a biomanufacturing plant.

3. To understand the importance of cGMP, including the history of the development of the FDA and cGMP.

4. To understand and adhere to documentation guidelines of cGMP. This involves writing and following SOPs and filling out batch records and log books.

5. To routinely monitor the environment for particle count and viable microorganisms.

6. To grow bacteria, mammalian cells and yeast cells, monitor their growth and generate growth curves. Growth rates will also be determined.

7. To purify a protein using filtration and chromatography techniques.

8. To evaluate protein production, purity and activity with ELISA, SDS PAGE and activity assays.

9. To evaluate samples for contamination by using Gram stain, LAL and mycoplasma detection assays.

10. To become a subject matter expert in an assigned piece of equipment.

11. To understand the importance of training records and to maintain training records.

Required Text(s):

Industrial Biotechnology, Moorpark College

Code of Federal Regulations Part 210 and 211

Reading Material Manual (handed out in class)

Lab Manual (purchased on LuLu.com)

Outline of Content:

Session / Lecture / Lab
1 / Overview of Biomanufacturing / Lab tour
Movie: Endostatin
Computer work: cGMP, Bb, protein/company project
2 / Amino acids and Proteins
Getting a Drug to Market
HW 1 due / Autoclave Instrument/cGMP Time
3 / History of cGMP / CFR Exercise
Air sampler Instruments/cGMP Time
4 / Documentation 1
Safety Procedures
HW 2 due / SOP exercise
Autoclave presentation
Validate autoclave
Spec & pH meter Instrument/cGMP Time
5 / Documentation 2
Amino acids/protein Quiz / cGMP Popcorn Exercise
6 / Facilities/Environmental Monitoring
Gowning / Millipore sampler and laser particle counter presentations
Gowning Practical Quiz
BSC Instrument/cGMP Time
7 / Growing Bacteria
Normal Flow Filtration/Filter Integrity Testing
Lab Report 1: Validating Autoclave / Make E coli media
spectrophotometer and pH meter presentations
8 / No Lecture (long lab) / Grow bacteria 4 shifts (8-11:30, 11:30-2:30, 2:30-5, 5:30-8)
Biolyzer and Applikon Instrument/cGMP Time
9 / Bacteria culture/GFP Production data analysis
HW 3 due / Count colonies, Gram stain
10 / Mammalian Cell Culture 1 / Make CHO media
Biological Safety Cabinet presentation
11 / QC micro: Mycoplasma and Endotoxin Detection / LAL Assay/Mycoplasma PCR
12 / Mammalian Cell Culture 2
Lab Report 2: Batch Culture of E. coli / Inoculate CHO cells
Sample (Trypan Blue Assay, Biolyzer)
Biolyzer presentation
13 / Bioreactors / Sample
Assemble and Autoclave Applikon Bioreactor
Applikon Bioreactor presentation
14 / Bioreactors
Lab Report 3: Mycoplasma/LAL / Sample
Scale Up into bioreactor, Sample
Bioflo 3000 Instrument/cGMP Time
15 / Separating Cells from Media and Cryopreservation / Sample bioreactor
Assemble Bioflo 3000 Bioreactor
Bioflo 3000 presentation
16 / Review for Exam / bioreactor, harvest
Cryopreservation
cGMP Time
17 / QC Micro and Documentation Exam
18 / QC Biochem: ELISA and Activity Assay / ELISA
19 / CHO cell culture/tPA Production data analysis
Growing Pichia
HW 4 due / Make Pichia media
Autoclave Bioflo 3000
cGMP Time
20 / Biopharmaceutical Production in Transgenic Animals / Inoculate Bioflo3000
21 / Competitive ELISA
Lab Report 4: Batch Culture of CHO Cells / Feed Pichia
22 / Pichia culture/HSA Production data analysis
Transgenics / Harvest Pichia
HSA ELISA
23 / Tangential Flow Filtration / Bioreactor Practical Quiz
Make buffers
TFF of HSA-Set up filter
SDS PAGE and BioLogic Instrument/cGMP Time
24 / Lab Report 5: Batch Culture of Pichia
Hybridomas
SDS PAGE / TFF of HSA
SDS PAGE
SDS PAGE presentation
25 / Chromatography 1 / Purification of HSA: pour and pack columns
Chromatography presentation
26 / Upstream Exam
2 / Chromatography 2 / Determine HETP of Columns
Purification of HSA: Run columns
cGMP Time
29 / Chromatography 3
Presentations due / SDS PAGE
30 / Protein/Company presentations
Lab Report 6: Purification of HSA / Purification of tPA: pour, pack columns and run column
31 / Protein/Company presentations
Purification Data Analysis
Review for Exam / SDS PAGE
Activity Assay
32 / Downstream Exam

Required Methods of Evaluation:

Lab Reports 30%

Exams 35%

Quizzes, presentations 15%

Documentation 10%

Homework 10%

Other Possible Performance Based Measures:

Lab participation

Participation in classroom discussions

Assessment Addendum

Acceptable substitute (such as curriculum specific PBLOs) may be attached instead of this addendum.

Instructions for completing the Course Content Outline Addendum:

Identify assessment techniques used to measure student learning outcome.

Use this form to explain assessment methods identified in the Course Content Outline.

1.  Identify assessment technique used to measure student learning outcomes.

  1. Identify the learning objective for this assessment. What will the student know or be able to do on completion of the course?

b. Identify the outcome measures used to document student learning.

  1. Lab Reports
  2. Objectives 6, 7, 8, 9
  3. Lab Reports will assess the students’ ability to understand experiments, relate theory to experiment, critically evaluate data, and present results in a clear, logical and well-written manner.
  1. Exams
  2. Objectives 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
  3. Exams will assess a higher level of understanding of lecture/lab material as compared to quizzes. Exams will assess knowledge and comprehension of material as well as application, analysis and synthesis of knowledge.
  1. Quizzes
  2. Objectives 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
  3. Quizzes will assess the students’ basic understanding of lecture/lab material. Knowledge and comprehension of material will be assessed.
  1. Presentations
  2. Objectives 1, 10
  3. Presentations will assess the students’ ability to train other students on their assigned piece of equipment. Presentations will also be used as a tool for the students’ to research a protein and company that manufactures the protein and present their findings to the class. Knowledge and comprehension of material will be assessed. Public speaking performance will also be evaluated.
  1. Documentation
  2. Objectives 3, 4, 11
  3. Documentation will assess the students’ ability to complete all the necessary paperwork associated with cGMP. Completeness of work will be evaluated.
  1. Homework
  2. Objectives 1, 2, 3, 4, 5, 6, 7, 8, 9
  3. Homework assignments will assess students’ ability to apply theoretical information to a problem solving environment. Accuracy of information, comprehension of material and level of preparation will also be assessed.

Curriculum Committee 2006-2007 Proposal Form 1