Speciality Chemicals Magazine SEP / OCT 2021 | Page 21

HIGH POTENCY APIS
HPAPI production at Lonza ’ s main site in Visp .
announced a CHF 100 million investment in API and drug product capacity . This was driven , said CEO Mark Griffiths , by patient needs , the growing velocity of development and customisation , particularly in the form of personalised medicine and multiple indications for both APIs and formulated products . The company is building small molecule API capacity at Hunzenschwil in order to meet anticipated growth in demand in the next ten years and beyond . This initially includes four reactor trains , all
high potency-capable and equipped with three vessels of up to 4,000 litres capacity , plus cGMP filterdrying and centrifugation capabilities . Construction will begin in October and it should be ready for customer projects in mid-2024 . This will create about 150 jobs . Carbogen-Amcis is also already expanding its drug product site at Riom , France , enabling it to take projects into Phase III and small-scale commercial manufacturing . About 60 new jobs will be created . Due to be complete in Q1 2022 and ready for operation in Q1 2023 , this will have two fully automated lines , one for sterile liquids and one for sterile solids with lyophilisation . Both will be high potency-capable at the highest OEL . This will give the firm niche-scale commercial capacity for the most complex of molecules , Griffiths said . Also in Switzerland , Helsinn Advanced Synthsis will spend CHF 70-80 million between 2022 and 2027 to build the ‘ Synthesis D ’ block at its Biasca site . This , general manager Waldo Mossi revealed , will have three HPAPI bays at OELs down to 1 μg / m 3 , with a separate area for technical services . Alongside this , a QC laboratory centre is already being built , with a dedicated area for oncology , in which Helsinn invested heavily in the past eight years . Construction on Synthesis D will begin next year . The first bay , UP1 , will be available in 2025 and will feature both Hastelloy and glass-lined vessels , probably of about 4,000 litres capacity . UP2 and UP3 will follow in 2026 and 2027 respectively . Each will have two reactors , plus associated technologies like milling , depending on client needs . Two further production units may be added in the next phase of investment between 2027 and 2030 , though the detail is yet to be decided . “ Innovation , digitalisation and sustainability are central in our vision ‣
Riom is the focus of Carbogen Amcis ’ s drug product investment
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