what is the difference between drugs and biologicals
In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination.
Chemical drugs are often more pure and better characterized by current analytical technology than biologics. A biologic agentâs activity may be affected by the cell system in which it is produced, the fermentation media, or operating conditions. The use of living organisms to produce therapeutic extracts is not new.