Overall it is required that CMO complies with good manufacturing practice from their client and regulatory bodies such as Food and Drug Administration.
CDMOs work on the scale-up and later stages of drug development often preparing materials ranging from hundreds of grams to multi-kilo amounts.
[3] The best-positioned service providers focus on a specific technology or dosage form and promote end-to-end continuity and efficiency for their outsourcing clients.
[5] Following the financial crash in 2008 the CMO industry started to be funded by private equity as a result of a substantial growth and a more qualified management.
[9][10][11][12][13][14] Novartis Sandoz acquired a site in Boucherville, Canada in 2018, as well as Glaxo Smith Kline, which began manufacturing out of South Carolina in the United States.
The bio/pharma companies used to build and staff dedicated manufacturing capacities for drugs in development only to see them canceled if the product failed in Phase III of clinical research; working with a CDMO limits that financial risk.
One of the major risk remains in the lack of control over the CDMO's compliance for the client, for example when an FDA warning letter is issued, a resulting interruption of production may result in major delay or interruption of shipping thus it is critical to properly vet the selected CDMO.