Summary of "How Biologic Medicines Are Made | Biomanufacturing"

Summary of “How Biologic Medicines Are Made | Biomanufacturing“

Main Ideas and Concepts

Difference Between Biologic and Small Molecule Drugs

Biologic drugs (e.g., monoclonal antibodies) differ significantly from small molecule drugs (e.g., aspirin) in their production.
Biologics require living cells for production, making the process more complex, time-consuming, and expensive compared to chemically synthesized small molecule drugs.

What is Biomanufacturing?

Biomanufacturing is the production of biological products using living cells.
It is used to make biologic medicines such as antibodies and enzyme replacement therapies.
Beyond medicine, biomanufacturing is applied in other industries, including environmental bioremediation (cleaning toxic substances) and food processing.

Detailed Biomanufacturing Process

Establishing the Cell Line
- Scientists engineer cells to produce a specific protein by transferring the gene encoding the protein into production cells.
- Common production cells include:
  - E. coli bacterial cells
  - Chinese hamster ovary (CHO) cells
- Once engineered, these cells multiply to form a genetically identical production cell line.
Creating the Master Cell Bank
- The production cell line is expanded in a bioreactor, a vessel containing nutrient-rich growth medium maintained under optimal conditions (temperature, pH, oxygen).
- Cells multiply over several generations, creating hundreds of millions of identical cells.
- The cell culture is collected and divided into many small vials (~1 million cells each).
- Vials are frozen in liquid nitrogen at -196°C to halt growth and preserve cells indefinitely.
- The master cell bank ensures consistent product quality over time and is stored in three separate locations for safety and redundancy.
Working Cell Bank and Production Cycle
- For each manufacturing campaign, a vial from the master cell bank is thawed.
- Cells are expanded for a few generations and then frozen again into a working cell bank.
- Production starts by using a vial from this working cell bank, ensuring consistency and reliability in the biologic drug manufacturing process.

Speakers/Sources Featured

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