Weekly Reflection

This week, we have learnt microbiological considerations of quality control of biotechnology products; aseptic conditions for the manufacturing of biotechnology products; additives used in parenteral formulation of biotechnology products; routes of administration and effects on the efficacy of biotechnology products; the effects of pegylation on pharmacokinetics of biotechnology products; and concept of targeted delivery of biotechnology products and the therapeutic benefits

Here are some key points for you to review what you have learnt this week. There is no need to answer them all. You could use these to check the gist of this week.

1. Discuss in general the route of drug administration, and specifically for biologics. Why oral route is not viable for biologic products? What are the applicable methods to improve non-parenteral bioavailability.

2. Compare the fundamental difference between the transport of small molecule drugs and large molecule biologics. Discuss the effects of molecular weight on lymphatic absorption vs vascular absorption, and the effect on renal excretion of biologics.

3. The chimerization process involves engineering the replacement of segments of the antibody molecule that distinguish it from a human antibody. Compare chimeric proteins, glycosylated proteins and pegylated proteins. While the molecular modifications are different, do they accomplish the same therapeutic objectives?

4. Summarize the additives for parenteral formulation of biologics, including solubility enhancer, anti-adsorption agent, anti-aggregation agent, buffer, preservative, anti-oxidant and/or osmotic agent. Give an example agent used in each additive category.

5. Encapsulate the microbiological requirements for sterility, viral decontamination and pyrogenicity test of therapeutic proteins. What is the most ideal way to sterilize biologics while maintaining viability and potency of the product?