Modernising pharmaceutical supply chains by onshoring chemical manufacturing
Steve Hedrick , chairman , president & CEO of AVN Corporation , reviews the societal and industry benefits of onshoring pharmaceutical chemical manufacturing
Early in the COVID-19 pandemic , challenges within the global supply chain began to demonstrate the importance of supply chain stability and security . Families and front-line healthcare workers struggled to access the necessary personal protection equipment , disinfectants and other critical equipment .
Today , this theme continues with the healthcare industry facing regular shortages of essential medications . 1 According to a report from the FDA ’ s Drug Shortages Task Force , the number of ongoing drug shortages has been increasing and they are lasting longer . 2
While it seems that attention on the pharmaceutical supply chain is now more heightened than ever , in fact this situation long predated the pandemic , starting with decades-old global supply chain landscapes . The systems and strategies put in place then must be right-sized and modernised for society ’ s needs . This starts with critical raw materials being produced domestically , distributed with purpose and accessed efficiently .
Re-emergence of US-based pharmaceutical chemistries
Pharmaceutical drug manufacturing has gradually moved out of the US . In 2019 , the FDA reported that only 28 % of API manufacturers supplying the US market were located domestically . The remaining 72 % were overseas . 3
Today , the US does not have the manufacturing capability to produce some key raw materials and intermediates at scale to support its pharmaceutical industry . Onshoring chemical manufacturing , specifically aminations fluorinations , and nitrations , has great potential to expand technology innovation that addresses the economic , technical and sustainability challenges presented by the global supply chain .
Recently , the Department of Commerce ’ s Rapid Assistance for Coronavirus Economic Response ( RACER ) grant was awarded to the RAPID Manufacturing Institute , of which AVN Corporation ( formerly Mid-Atlantic Technology , Research & Innovation Centre ( MATRIC )) is a sub-awardee . The grant has created a Centre of Excellence for Process Technology that is based on a new , standardised process development framework to streamline chemical manufacturing processes from bench to commercial production .
This leads to the development of continuous processes for critical materials for the pharmaceutical industry that are currently substantially produced overseas . AVN , applying its infrastructure and subject matter expertise , is focused on accelerated process design through modular processing .
By onshoring the capability to move critical pharmaceutical material manufacturing processes from concept to commercial products , faster response times and fewer supply chain disruptions will be possible within the US . The efforts to onshore bring forth the possibility to ensure
28 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981