Sterility testing is required during the sterilization validation process, as well as for routine quality control and detecting major contamination in a batch.
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.
Drug discovery and development is expensive; of all compounds investigated for use in humans only a small fraction are eventually approved. This approval comes only after heavy investment in pre-clinical development and clinical trials, as well as a commitment to ongoing safety monitoring. Biopharmaceuticals are drugs produced using biotechnology.
They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.
There is a trend toward Biopharmaceuticals (as opposed to traditional small molecules produced by chemistry techniques) due to the potential specificity and potency against a target disease. However biopharmaceutical processes require greater application of Aseptic processing and the associated environmental controls and monitoring to ensure this is achieved.