02/09/2015

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MITx: 10.03x Making Biologic Medicines for Patients: The Principles of B

Humans have leveraged the power of cells for millennia to produce staples such as bread, cheese,
beer and wine. Yet only recently have we begun to utilize cells as factories for the production of
protein therapeutics.
These biologic drugs are able to treat otherwise untreatable diseases. In this course, you will learn
how these life saving medicines are made.
We will connect the engineering fundamentals to real-world application by showing real pieces of
biomanufacturing equipment in action and listening to experts describe real-world engineering
challenges.
During the next six weeks, we will cover the following subjects:

Unit 1: Introduction and History

Unit 1 will cover theIntroduction and Historyof biopharmaceutical manufacturing. During
theweek we will:
Introduce you to what biologic medicines are and why they are important for the treatment of
disease,
Cover some of the key historical developments that lead to modern biomanufacturing,
Provide you with an overview of what modern biomanufacturing is.

Unit 2: Protein Structure and Function

Unit 2 will cover Protein Structure and Functionand its importance in manufacturing biologic
medicines. During the week we will:
Describe amino acids, the key building blocks of proteins,
Introduce a way to classify a protein based on its function,
Identify some post-translational modifications that can happen to biologic medicines and why
they are important,
Teach how changes in the structure of insulin and a monoclonal antibody can have significant
impacts to their therapeutic function.

Unit 3: Cell Line Development

Unit 3 will cover Cell Line Development,an important first step in the manufacture of a biologic
medicine. During the week we will:
Teach you how cells are engineered to produce a target biologic medicine,
Introduce what an expression vector is and how it can be modified to increase protein
production,
Review how a single cell (or clone) is selected to be the parent cell for manufacturing,

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Define what a Master Cell Bank is and describe its role in biopharmaceutical manufacturing.

Unit 4: Upstream Processing

Unit 4 will cover what is known as Upstream Processing,which is the process of cultivating our
chosen production cells in a bioreactor for optimal production of our target protein. Duringthe
week we will:
Identify the steps in upstream processing,
Teach you how cellular metabolism controls protein production and impacts bioreactor
design,
Cover common methods of bioreactor operation,
Introduce important concepts in masstransfer and mixing to enable the design of an
optimal culture process,
Teach you how to maintain similar cultivation conditions for both small and large
bioreactors.

Unit 5: Downstream Processing Part I

Unit 5 will cover Downstream Processing Part 1. Downstream processing is when the raw material
produced in the bioreactor is processed into a pure drug substance. During the week we will:
Introduce the four steps of downstream processing: primary recovery, initial purification,
polishing and formulation,
Review protein structure and how we can leverage differences to separate two protein
products,
Teach you how centrifugation can be used to remove cells fromthe cell culture fluid,
Introduce a number of methods to break open cells and recover any intracellularly
produced proteins,
Teach you about filtration and how it can be used to separate particles based on differences
in their size.

Unit 6: Downstream Processing Part II

Unit 6 will cover Downstream Processing Part 2, and will pick up where Unit 5 left off. During the
week we will:
Introduce you to chromatography, the most common technique used in the purification of
proteins,
Teach you about the most common methods of chromatography, including gel permeation,
ion exchange, hydrophobic interaction, and affinity chromatography,
Compare the differences between the purification of two different biologic products,
Teach you how downstream processing also removes potential viral contaminants.

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