Manufacturing in Life Sciences: What’s it all about?

From a product perspective, pharma manufacturing consists of drug substance or API (Active Pharmaceutical Ingredients) production; drug product (tablets, liquids, creams, capsules, etc.) manufacturing, and packaging (primary, secondary and tertiary packaging).

The drug substance consists of either large or small molecule production: large molecules are biologics (proteins, antibodies, conjugates etc.) which are produced by mammalian or microbial fermentation, cell extraction etc.; small molecules are chemical entities produced by chemical synthesis. Production sites are normally equipped to handle one or other of these processes, as each process is fairly unique to the product and requires designated equipment.