PHARMA SPECIAL
Snapdragon honoured for API development
Cambrex ’ s recently acquired operation Snapdragon Chemistry won the API Development Award at CPHI Barcelona . This is presented to a company that demonstrates innovation in technologies , products , processes and services for the development and manufacture of APIs .
The award honoured the development of an ultra-high temperature continuous flow manufacturing process for the racemisation of sotorsib P-dione by-product from a commercial manufacturing process at Amgen . This resulted in a 58 % reduction of process mass intensity and is projected to save thousands of tonnes of waste .
Cambrex recently completed a 1,100 m 2 expansion at Snapdragon ’ s facility in Waltham , Massachusetts , adding new process R & D suites , a GMP stability suite and a fifth GMP kilo lab . The company has also just completed a $ 38 million doubling of capacity at its small molecule API facility in High Point , North Carolina . issues , later because of supply chain security . Now , questions are being asked about how real this trend is .
Luzeau of Seqens has observed a growing ‘ regionalisation ’ as customers diversify their supply chains to keep more production nearer to home . However , he said , globalisation has not stopped and inter-regional trade is returning after the end of the pandemic
Suven ’ s Shaughnessy noted a shift in Big Pharma priorities . The focus is now on cost-containment ahead of a big patent cliff , leading to a lot of pressure on CDMOs but also to a quiet shift away from the ‘ China + 1 ’ strategy so many had previously announced . “ The low cost of China has brought them back ,” he said . Poncet of Minakem has seen evidence of reshoring in the US , largely as a result of the Biden administration ’ s active promotion of US-based manufacturing via the Inflation Reduction Act . In
Europe , he said , there is more talk than action . By contrast , Adrian Hanrahan , managing director of Robinson Brothers , said he had seen “ a real drive ” to it in the EU and the UK .
Geopolitics , as ever is the great imponderable . Neither the Ukraine war or the current Middle East crisis has had huge impacts , according to Kaus of Curia , but rivalry between the US and China could change everything . Then there are energy costs , which may have reached a plateau but are still higher than expected and are showing no signs of returning to pre-COVID levels .
Rise of China
Stanton also highlighted the emergence of China in biopharmaceuticals . According to Bioplan Associates , China is now the world ’ s second largest pharmaceuticals producer ; other estimates say that it accounts for 15 % of the roughly 6,000 drugs in clinical development , up from just 2 % in 2007 , largely at Europe ’ s expense .
The top Chinese companies are now , like their Western counterparts , developing drugs with innovative mechanisms of action and targets . It is still hard to say when China will be launching bestin-class biologics globally , Stanton added , but China is no longer a low-cost manufacturing hub . Input costs , including wages , have soared and the average cost of producing a gram of recombinant protein is now higher in China than the US .
Some see China as the land of opportunity for Western CDMOs . Unlike in India , where they are clearly growing strongly , China has relatively few . The exception is WuXi Apptec , which had the largest single stand at CPHI . Asymchem and SCA are believed to be the next largest but they are a long way behind in their marketing and general presence . ●
NOV / DEC 2023 SPECCHEMONLINE . COM
21