Advances in Contract Manufacturing

A contract manufacturer ("CM") is a manufacturer that contracts with a firm for components or products. It is a form of outsourcing. In the food business a contract manufacturer is called copacker. In a contract manufacturing business model, the hiring firm approaches the contract manufacturer with a design or formula. The contract manufacturer will quote the parts based on processes, labour, tooling, and material costs. Typically a hiring firm will request quotes from multiple CMs. After the bidding process is complete, the hiring firm will select a source, and then, for the agreed-upon price, the CM acts as the hiring firm's factory, producing and shipping units of the design on behalf of the hiring firm. There are many benefits as well as risks to contract manufacturing. Companies are finding many reasons why they should be outsourcing their production to other companies. However, production outside of the company does come with many risks attached. 

In 2015, the global pharmaceutical contract manufacturing market generated $13.43 billion in revenue. The forecast shows a compound annual growth rate (CAGR) of 6.6% from 2012 to 2017. o The injectable dose formulations segment will likely be the primary growth driver for outsourcing throughout the forecast period. In 2015, solid dose formulations was the largest segment, constituting 49.8% of the total pharmaceutical contract manufacturing market, and is projected to grow at a CAGR of 3.4% from 2012 to 2017. Generics will likely be a key growth driver for the solid dose formulations segment; however, this segment will likely lose shares to the injectable dose formulations segment because of big pharma’s shift in focus from small molecules to large molecules

Contract manufacturing organizations (CMOs) offer a wide array of manufacturing services to the pharmaceutical and biotechnology industries. These services can range from production of small quantities of materials for R&D purposes, larger amounts for clinical study usage and ultimately full-scale production for commercial purposes. The global contract manufacturing market primarily includes solid and liquid dosage forms and injectable. The growing use of generic drugs and complex pharmaceutical products has also induced many CMOs to offer active pharmaceutical ingredient (API) manufacturing services to their clients. The decision to outsource manufacturing was primarily based on the need to acquire a new skill or to compensate for a lack of in-house, internal capacity. However, over the last decade or so, the decision to outsource has been strategically embraced as a way for pharmaceutical companies to: 1) reduced costs, 2) lower drug development risks, 3) adapt to shifting manufacturing requirements, 3) gain access to manufacturing expertise and, 4) reduce drug commercialization development times

  • Contract manufacturing arrangements for drugs: Quality agreements
  • Establishing responsibilities of contract manufacturing
  • Analytical services for contract manufacturing
  • Production and filling of pharmaceuticals
  • Validation process
  • Use of CMO in life sciences
  • Advantages & disadvantages of using CMOs

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