Contract Manufacturing Organization

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In the pharmaceutical industry, a Contract Manufacturing Organization (CMO) is a contract manufacturer who produces various intermediate products of a drug or the final product on behalf of a pharmaceutical company .

Contract Manufacturing Organizations have established themselves alongside the Contract Research Organization in the pharmaceutical industry and are used to outsource various process steps in the manufacture of a medicinal product. In addition to the pure production of a product, some companies already offer support in research and development such as synthesis, formulation development, stability studies or in the transfer from the laboratory process to the large-scale plant ( scale-up ). These are called Contract Development and Manufacturing Organizations (CDMO, for contract manufacturers and developers). In 2011, global revenue from contract manufacturers for the pharmaceutical industry was $ 31.9 billion, while sales are forecast to grow to $ 63 billion in 2017. The largest CMOs in terms of sales (2020) include Samsung Biologics , Lonza and Boehringer Ingelheim .

Advantages and disadvantages of CMOs

Contract manufacturers are specifically called upon to avoid capacity problems in their own plants or because of the fact that this outsourced product has already arrived at the end of the project cycle. This means that internal resources can also be better planned. At the beginning of the selection of a contract manufacturer, however, a risk analysis ( due diligence ) is necessary in order to minimize any risks that may arise. Points such as the use of appropriate quality systems, successful audits by health authorities (e.g. the US health authority FDA ) or risks from any language barriers that may arise must be clarified at the beginning of the selection of a contract manufacturer.

Pros and cons for CMOs

Contract manufacturers, for their part, can become dependent on their customers through contract manufacturing of various intermediate stages of a drug. Due to the market power of your client, for example, large discounts can be requested. Low-volume products (such as orphan drugs ) or generics, as well as changes in the efficiency of manufacturing processes, can become challenges for CMOs.

Individual evidence

  1. ^ Contract Manufacturing Organization (CMO). Contract Pharma, accessed June 20, 2014 .
  2. ^ Contract Development and Manufacturing Organization (CDMO). Contract Pharma, accessed June 20, 2014 .
  3. ^ The Benefits Of Contract Manufacturing. VertMarkets, Inc., accessed June 20, 2014 .
  4. ↑ Top 10 CMOs visualized by revenue and employment. outsourcing-pharma.com, accessed June 21, 2014 .
  5. ↑ a b CMO Market Report. Contract Pharma, accessed June 20, 2014 .
  6. ↑ a b Due Diligence - Selecting a Contract Manufacturing Organization (CMO). Monitor Publishing Inc., accessed June 20, 2014 .