Course Introduction

Fundamentals of Biomanufacturing provides a general overview of the production of drug

substances used in drug products that help prevent or treat human diseases. The course
materials are available online and can be completed at your own pace but must be completed
within three months of initiation. The course is divided into 13 modules (see below). Each
module contains lessons and an assessment.
Basic Principles
No. Title Topics
1 Introduction to biological • Properties of biological products.
products and pharmaceutical • The differences between biological products and
drugs pharmaceutical drugs.
• Vaccines.
2 Proteins • Formation, structure, and properties of proteins.

3 The four stages of • Overview of biomanufacturing

biomanufacturing
• Introduction to the four stages of Drug Substance
manufacturing:
1) Cell Growth (Production).
2) Harvest.
3) Purification.
4) Formulation and Fill.

4 Good Manufacturing Practice • Principles of Good Manufacturing Practice (GMP).

(GMP) • Controlling the process, facility, equipment,
personnel, and procedures to ensure compliance
with GMP.
Upstream Bioprocessing
No. Title Topics
5 Expression systems and • Expression systems used to over-produce a target
biotechnology protein.
• Components of an expression system.
• Basic steps for generating an expression system.
6 Nutritional strategies and cell • Nutritional components of basal media.
culture media • Reasons to avoid serum.
• Purpose and design of feeds.
7 Cell growth • Phases of cell growth.
• Modes of bioreactor operation.
• Analyzers used to monitor a cell culture.
8 Bioreactor design, operation, • Design of stainless steel.
and control • Single-use disposable bioreactors.
• Critical process parameters.
• Process control.

Downstream Bioprocessing
No. Title Topics
9 Cell separation: centrifugation • Separation of cells, cell debris, and/or other solid
and depth filtration particles from a liquid.
• Differences between centrifugation and depth
filtration.
10 Chromatography • Use of chromatography to increase the purity of
the target protein.
• Selection of the appropriate chromatography resin.
• Operating modes.
11 Viral clearance • Types and sources of common viruses.
• Inactivation or removal of viruses during
production of drug substances.
12 Ultrafiltration and diafiltration • Ultrafiltration and diafiltration.
• Membranes and equipment configurations used
for ultrafiltration and diafiltration.
13 Bulk filling • Equipment and procedures used for bulk filling.