Biomanufacturing
At Mount Wachusett Community College
Funded in full or in part by the U.S. Department of Labor Grant CB-17329-08-60-A-25
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Number
BIO109
BTC101
BTC102
ENG101
General Elective
CHE203
Professional Elective
CIS127
ENG102
MAT143
BIO160
BTC110
HUM212
PER126/130
Suggested Course Order
General Biology
Introduction to Biotechnology
Basic Solution & Media Preparation
English Composition I
Introduction to Inorganic, Organic and Biochemistry
Cr
4
4
3
3
3
4
Computer Technologies
English Composition II
Probability and Statistics
Principles of Biochemistry
Biotechnology Experience: Concepts and Procedures
Medical Ethics
Health, Fitness, & Wellness Elective
3/4
3
3
3
4
4
3
2/3
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BTC120
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BTC200
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BIO170
Cell Biology
Social Science Elective
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Biotechnology Experience: Biomanufacturing
Biotechnology Seminar
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Associate’s Degree
4
3
4
3
Total: 60/62 credits
Funded in full or in part by the
U.S. Department of Labor Grant
CB-17329-08-60-A-25
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4 credit class
 Two lectures/week – 75 minutes each
 One lab/week – 2 hours
◦ OR
 One class/lab per week – 4 ½ hours
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Workforce Training Program
◦ 3 days/week – 7 hours/day
Class Format
Funded in full or in part by the
U.S. Department of Labor Grant
CB-17329-08-60-A-25
Date
Jan.
21
28
Class
Lab
Overview of the
structure of the course
Introduction to
Biomanufacturing
Metrology
Tour of Lab Scale Biomanufacturing Lab
Assign equipment SME’s (subject matter experts)
Calibrate balances, pH meters and pipettes
SME Autoclave Training
Metrology
Feb. 2
Validation
26
SME Autoclave Presentation
Validate autoclave operation
SME Environmental Monitoring Training (Millipore Air
Sampler)
4
Validation
9
Validation
11
Validation
16
Environmental Health
and Safety
18
23
Environmental Health
and Safety
Quality Assurance
25
Quality Assurance
March
2
Quality Control –
Microbiology
Midterm Exam
Quality Control –
Microbiology
Gowning
Microbial air testing
Gram Staining
Quality Control –
Microbiology
Midterm Exam
LAL assay
Mycoplasma testing
Production Overview
Aseptic technique
CHO – tPA Core Production System
4
9
11
15-19
23
Perform IQ, OQ and PQ on autoclave, pH meter and balances
EH&S Biomanufacturing Lab Safety Check
MSDS file location
Chemical Inventory List
SME Environmental Monitoring Presentation (Millipore Air
Sampler)
cGMP Popcorn exercise
25
Upstream Processing
30
Upstream Processing
31
Wednesday
April
1
2
Friday
3
Saturday
5
Monday
6
Upstream Processing
April
7
8
Wednesday
13
Downstream
Processing
Downstream
Processing
15
20
22
27
29
Spring Break
May 4
6
check media for contamination; store at 4°C
check results of media hold
CHO – tPA Core Production System
 Assemble and Autoclave Bioreactors
 Spinner flasks – media hold
Inoculate spinner flasks (time zero)
CHO – tPA Core Production System
 Time 1 spinner flask testing
Bioreactor media hold
CHO – tPA Core Production System
 Time 2 spinner flask testing
CHO – tPA Core Production System
 Time 3 spinner flask testing
CHO – tPA Core Production System
 Time 5 spinner flask testing
 Scale up to bioreactor
CHO – tPA Core Production System
 Time 1 bioreactor testing
Mycoplasma PCR
CHO – tPA Core Production System
 Time 2 bioreactor no testing required
CHO – tPA Core Production System
 Time 3 bioreactor testing
Harvest and Cell Banking
Column chromatography
No class - Gardner on Monday schedule
Downstream
Processing
Quality Control
Biochemistry
Purification of tPA
 Ion exchange chromatography
tPA production assay
 tPA ELISA
 SDS PAGE of purified tPA
 CHO cell culture/tPA production data trend analysis
QC biochemistry
 Review SDS PAGE results
Quality Control
Lab Exam
Biochemistry
Quality Control
Biochemistry
BTC120 Biomanufacturing Course
Schedule
Funded in full or in part by the U.S. Department of Labor Grant CB-17329-08-60-A-25
Workforce Training Program
Funded in full or in part by the U.S. Department of Labor Grant CB-17329-08-60-A-25
Aseptic Technique
•Very
important!
Funded in full or in part by the
U.S. Department of Labor Grant
CB-17329-08-60-A-25
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CHO cells
◦ Contain gene
for tPA
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Approximately
3 weeks
◦ 100ml spinner
flasks
◦ 3L bioreactors
Upstream Processing
Funded in full or in part by the
U.S. Department of Labor Grant
CB-17329-08-60-A-25
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Centrifugation
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Low pressure liquid
chromatography
◦ Ion exchange to
purify tPA
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ELISA
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SDS-PAGE
Downstream Processing
Funded in full or in part by the U.S. Department of
Labor Grant CB-17329-08-60-A-25