Overview of the Manufacturing Process

Question 1

What is Biotherapeutics?

Answer 1

Biotherapeutics are drugs that are produced from a biological source and not synthesised chemically.

Question 2

What is Manufacturing?

Answer 2

Refers to the process of converting raw materials into useful products.

Question 3

Pharmaceuticals vs Biopharmaceuticals

Answer 3

• The primary difference between biopharmaceuticals and traditional pharmaceuticals is the method by which the drugs are produced.
• Pharmaceuticals are drugs/chemicals with a medicinal property
• Pharmaceuticals are traditionally small molecules synthesised chemically, whereas biopharmaceuticals are bigger and are synthesised using biological sources.
• Pharmaceutical drug discovery largely consists of finding new compounds that specifically disrupt only disease-associated processes, since the drugs are small it is tricky to discover processes which only target the problem.
• Biological drugs are larger so this can be an asset in targeting the problem i.e. an antibody could attach to a specific point and trigger an inhibitory effect which stimulates an immune response.

Question 4

What is the schematic of a typical bioprocess?

Answer 4

1. Upstream process, which includes:
   - Microbiology - i.e. recombinant DNA and type of cell
   - Engineering - Bioreacter types, Growth conditions, media design, mass balance, kinetics & time
2. Downstream process, which includes:
   - Chemistry - intracellular/ extracellular products, or biomass products, purity level required

Question 5

What does the upstream process include?

Answer 5

• Wild type cells
• Inserting recombinant vectors
• Gene manipulation (Bacteria, yeast, fungi, plant, mammalian)
• Fermentation / Growth
• Recombinant cells

Question 6

What does the downstream process include?

Answer 6

• Separation of cell debris from media
• Purification

Question 7

Why do we need to use cells?

Answer 7

• Viewed as a cleaner method of production, using renewable feedstock and a more sustainable, less toxic manufacturing process.
• Products that are synthesised come from the cell’s own metabolism - this is important because this means that the cell is not in much strain and it doesn’t have much knock-on effect on the cell so the cells don’t get modified (mutate)

Question 8

What are the 2 types of metabolism?

Answer 8

Primary and secondary metabolism

Question 9

What is Primary Metabolism?

Answer 9

Primary metabolites are the compound that are directly involved in the metabolic pathway of an organism necessary for its growth, development and production.

Question 10

What is Secondary Metabolism?

Answer 10

Secondary metabolites are the organic compounds that are produced by various organisms that are not directly involved in the growth, development or production of the organism but are essential in the ecological and other activities.

Question 11

What products can be made from bioprocesses?

Answer 11

Antibodies, Vaccines, Recombinant proteins and Monoclonal Antibodies (Mabs)