There are different types of manufacturing units, in the life science industry, out of the R&D centers.
The pilot plant - often being a part of a larger site - is the smallest unit where API's are produced in a very limited quantity ( often grams ). In the pilots, the process is validated and used for the future productions.
The scale-up is producing more than the pilot - a limited number of countries are normally concerned with the production of the drug, in principle a new one.
The multipurpose plant - producing larger quantities of different substances - is the most common size. Generics, vaccines are typical examples of drugs which are concerned.
The dedicated plant is the largest facility. Blockbusters and large production of certain substances are produced there.
We have to differenciate the facilities where substances are produced (API's, excipients, additives) and DP (drug production) where mixings, packaging, and conditionments are done.
The production of the active substances (Active Pharmaceutical Ingredients) can be either extracted from a process based on a chemical synthesis or from a biosynthesis. The bioprocesses are booming, and will be a major trend for the next decade.
Some typical steps of the process : |
