INTRODUCTORY BIOMANUFACTURING
A 15 Week Introductory Course for High School/CC Students
NBCC Curriculum Outline
Minuteman Regional HS
Session
1
2
3
Lecture
Introduction to
Biotechnology
Modern
Biotechnology:
Making
pharmaceuticals
Basic
Microbiology
Unit 1
Lab Experience
Documentation,
Laboratory
Notebook,
Introduction to
Instrumentation,
Safety in the Lab
Use of
Bioengineered
Enzymes in
Manufacturing
Settings
Basic Aseptic
Technique :
Media
Preparation,
BSC use and
Sterile Filter
Techniques
Job Descriptions and Competencies
Process Development Associate, Upstream/Downstream
Manufacturing Technician,
Instrumentation/Calibration Technician
Maintain lab notebook,
Prepare samples for specific tests,
Perform calibration, follow lab safety procedures
PC skills
Downstream Technician, Process Development Associate,
Chemistry QC technician
Maintain lab notebook, use spectrophotometer
Analyze data
Prepare data base, create tables, graphs
Upstream/Downstream Manufacturing Technician
Microbiology QC Technician
Environmental Health and Safety Technician
Perform basic microbiology lab techniques
Weigh, prepare and sterilize media, autoclave,
perform sterile filtration, test for bioburden
Read and understand SOPs, document activities using
GMP principles
4
5
6
7
Basic
Microbiology
Identification of
Bacterial Types
Unit 2
How do we identify
Microbes?
Staining,
Morphology&
Metabolism
FDA
History and
Current Good
Manufacturing
Practice
21 CFR Parts
210&211
GMP Popcorn
Activity
Microbiology Technician QC Technician
Environmental Health and Safety Technician
Instrumentation/Calibration Technician
Test for quality of media/reagents
Monitor personnel
Review Data
Validate equipment, methods
Facilities Technician
QA Documentation Coordinator
Upstream/Downstream Processing Technician
Microbiologist QC Technician. Chemistry QC Technician
Develop, review, revise and update SOP’s
Use GMP when working with all documentation
Establish plant or material Flow(Dirty/Clean)
Basic Techniques, Measurement
Process Development Associate, QC technician,
Solutions and
using balances,
Upstream/Downstream Technician,
Instrumentation spectrophotometer, Instrumentation/Calibration Specialist
pH meter,
Preparation of
Test buffer/media quality, weigh and dispense reagents,
buffers
develop protocols
Maintain Safe
Read and extract information from manuals, understand
Environment
MSDS, Use PC skills
Organism
pGlo
Process development, QC technician
Transformation Transformation of
E. Coli
Develop protocols, design and or implement experiments
8
9
10
11
12
The Rain Forest:
How to find new
pharmaceuticals?
Bioinformatics
DNA search for
new medicines
Process Development Associate
Perform literature search using the internet/library
Design and/or implement experiments
Isolation of
Grow, homogenize Process Development Associate, Upstream Processing
Products of
and isolate purified Technician, Microbiology QC Technician
Biomanufacturing pGLO protein
Powerpoint
Maintain cultures, screen and clone cultures, prepare
Presentation of
documentation, prepare buffers/media, design and/or
Isolation
implement experiments, use instrumentation
techniques
Perform recovery of product by homogenization,
centrifugation and filtration protocols
Write approved protocols
Adhere to GMPs
Proteins and their
Preparation and
Process Development Associate, Downstream Processing
purification
use of column
Technician
chromatography
Prepare solutions, Clean environment,
Pack columns
Column
Use of SEC, HIC, Process Development Associate, Downstream Processing
Chromatography
and Anion
Technician, Chemistry QC Technician
Exchange Columns
Perform protein purification on columns
Filter product as necessary
Operate and use control systems
Sample and manage process testing on material
Purity of Product
PAGE
Chemistry QC Technician
Techniques
Test Samples
Provide information to necessary personnel (QA)
Follow GMPs
Perform and support validation
13
14
15
16
Bioethics in the
Teaming and
Biomanufacturing Producting the
Best
Possible Product
Engineering in
Process Control
Biomanufacturing
and Robo Dacto
Lab
Final Product
Analysis
For Purity
Final Product
Polishing and Fill
Clinical Trials
ELISA
Clinical Trial
Board Game
All Personnel
Process Development Associate
Validation Specialist
Upstream/Downstream Processing Technician
Process Control in the maintenance of both growth of cells
and purification of product
Adhere to GMPs, Health and Safety rules
Process Development Associate
Chemistry QC technician
Microbiology QC technician
QA Documentation Coordinator
Perform product concentration assays
Analyze media components
Write/implement approved protocols
Test samples
Provide customer service
Comply with regulations
Process Development Associate
Downstream Processing Technician
Chemistry QC technician
Microbiology QC technician
QA Documentation Coordinator
Perform Protein Purification
Prepare final material for animal studies
Prepare documentation
Test samples
Provide customer service
Comply with regulations
Conform with Health and Safety Procedures
Perform testing for sterility of product
Manage Documentation/Information and Records