AUGUST 2023LIFE SCIENCES REVIEW8IN MY OPINIONMHOW CMOs/CDMOs CAN ADD VALUE FOR PHARMA COMPANIESBy Ozgur Akbulut, Director, Global Divestments and Contract Manufacturing Lead, Takeda [NYSE:TAK]ore and more pharma companies are interested in shifting volumes to CMOs / CDMOs. The level of contract manufacturing in more conventional technologies like small molecules ­ solids have reached to 40+ percent of industry volume. The rest of small molecules technologies such as liquids, semi-solids, injectables have increased dramatically. CMOs/ CDMOs are becoming more and more sophisticated, and we see CMOs/CDMOs very active and successful in Oncology, Steroids, Highly-Actives and large molecules. Thanks to CMOs/CDMOs that we are able to get Covid-19 vaccines in large quantities. Some resources estimate that 70 percent of small molecules will be manufactured by CMOs/CDMOs in next 10 years and the share for the more complex technologies are still in the early phase and will grow significantly.The demand for Contract Development is also increasing significantly. To accelerate, increase and optimize their product development cost, many pharma companies use CDMOs at an accelerated rate. However, the scope of this article is CMO space which is closer to my area of expertise.Another factor in CMO/CDO space is manufacturing site divestment by big pharma companies. Traditionally, big pharma companies had their own manufacturing sites and manufactured their own products. Big pharma companies have 10 to 80 manufacturing sites and employ up to a few ten thousands of highly qualified employees. As a part of product life-cycle, pharma companies divest their mature products and divest the relevant manufacturing site together with the product and or separately to a CMO/CDMO organization. More and more CMO/CDMO and investment institutions are interested in acquiring manufacturing sites from big pharma, optimizing them, piping in new volumes and turning into profitable businesses.Let's start with the question. What are the expectations of pharma companies from CMOs? Here are few main things to consider;1. Quality and Safety: This are the foundations of the making business with pharma companies. In other words, these are the licenses to operate. Pharma companies do not take risk in these areas and CMOs/CDMOs should have solid Quality and Safety organizations and procedures in place. Quality departments should be independent from the site management and should make its decisions freely. Luckily, more and more pharma companies Ozgur Akbulut
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