NEWS
HPAPI expansions for four
Lonza has completed an expansion at its API manufacturing site at Nansha , China ( pictured ), as part of its recent investment to expand mid-scale capacity there . This focused on extending the capabilities and capacities of development laboratories and kilo-scale cGMP manufacturing laboratories for clinical supply of HPAPIs . The footprint has been expanded to 250 m 2 , with additional analytical and manufacturing equipment . Operations are scheduled to begin this month . The company also revealed that the first European and US-based customers have signed HPAPI programmes for the new laboratories . Among these is the drug substance for Cantrixil , a late-stage ovarian cancer therapy in development by Sweden ’ s Oasmia Pharmaceutical . Lonza has already begun kilogram-scale synthesis , purification and stability testing , and will deliver cGMP batches of drug substance for clinical supply in Phase II . Meanwhile , Novasep will invest a further € 5.1 million at its site in Le Mans , France . It will add a new chemical synthesis workshop for HPAPIs , which will be commissioned in late 2023 , creating ten full-time jobs . The company said that this will support its growth in the strategic ADC sector , where there has been a wave of approvals .
Switzerland ’ s Cerbios-Pharma has revealed that it is near to finalising the structure of its new HPAPI facility at Lugano . This will host two cGMP SafeBridge Category 4 lines for cytotoxic molecules in batches of 200 mg to 2 kg , and additional space for dedicated R & D and QC labs . This is due to be operational in Q2 2023 , following fitting and installation of the equipment HPAPIs will also be part of the expansion recently announced by Japan ’ s AGC in a 7,500 m 2 building at the site of its AGC Pharma Chemicals Europe operation in Spain . Costing about $ 100 million , this is scheduled to begin operation in 1H 2024 and will add 30 % to the site ’ s capacity . This comes on top of a 30 % increase in capacity announced in April 2020 .
Sanofi outlines plans for EuroAPI
Sanofi ’ s newly established API manufacturer EuroAPI will begin trading on the Euronext Paris on 6 May , subject to shareholder approval at a meeting three days before . Following this , EuroAPI will operate independently . “ This important step towards our listing is a key milestone for EuroAPI and is part of the deployment of our strategy and our independence from Sanofi ,” said CEO Karl Rotthier . The firm will be 58 % owned by Sanofi shareholders following a share distribution in addition to a proposed € 3.33 / share cash dividend . Sanofi itself will retain a 30 % stake and “ will remain a long-term strategic partner , supporting EuroAPI ’ s growth ambitions as an independent company ”. It represented nearly half of EuroAPI ’ s revenues in 2021 . Bpifrance , acting on behalf of the French State under the French Tech Sovereignty Convention of December 2020 , will hold the remaining 12 % for up to € 150 million . The exact price will be determined based upon the thirtyday volume weighted average trading price , starting on 6 May . It will also have two board members .
6 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981