7.4 A focus on biopharmaceutical production
To ensure that the medications we take are safe, we make them comply with many regulations and an enormous degree of quality control. Biopharmaceuticals are pharmaceuticals which often must be purified from complex biological sources; they have very strict controls to ensure they do not contain harmful contaminants.
One class of monitored contaminants is endotoxins. Endotoxins are lipopolysaccharides found in the cell wall of gram-negative bacteria. They can elicit an immune response in humans and other animals which leads to inflammation, fever and in extreme cases anaphylaxis and death.
Drugs must often be tested in animal models. The US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) regulations stipulate that the dose limit of endotoxin does not exceed 5 endotoxin units (EU) per kg of body weight for rabbits.
If a drug ‘x’ needs to be injected at a dose of 0.1 ml kg–1 but contains 184 EU ml–1 is it safe? (The average weight of a rabbit is 5 kg.)
Biopharmaceutical Production
Adi Alhuwaider is a senior research assistant at St Vincent’s Institute for Medical Research. He has extensive experience in research and in the production of biopharmaceuticals. Watch an interview with Adi to learn how to solve the problem above but also to see how important quantitative literacy is for working in drug development and production.
