Lecture 17 - biologics

Question 1

what are biologics?

Answer 1

A biopharmaceutical, also known as a biologic(al) medical product, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources….they include vaccines, blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy.

Advantages:
High specificity and reduced side effects for patients
Difficult to reproduce/copy, protecting manufacturers

Question 2

what are challenges of biological vs small molecules?

Answer 2

Complex production process
Costs (of setup)
Costs to patients (and healthcare systems)
Cold supply chains (tertiary structures etc)
Public concerns over source materials
IV products
Sterile products (not suitable for heat sterilisation)
Need trained staff

Question 3

what are sources, products and process in biologics?

Answer 3

Sources: animal, plant, virus, bacteria, fungi, could be transgenic.

Processes: tissue/fluid collection or donation, harvesting, cell culture, fermentation, isolation, purification, formulation, filling, sterilization.

Products: hormones, vaccines, enzymes, immuno-sera, Ab, gene/cell therapy products, tissue products