HIGH POTENCY APIS
Evonik is expanding at two sites
‣ for the development of the plant ,” said Mossi . “ Together with academic partners , we are also developing a new concept for HPAPI development , including the possibility of combining manufacturing technologies with engineering controls and robotics .” ( While not a part of the DCAT Week announcements , yet another Swissbased CDMO , Cerbios-Pharma , has also recently launched and secured Swissmedic approval for a new HPAPI drug substance plant . This features containment allowing OELs down to 30 ng / m 3 and can manufacture batches of up to 35 kg in reactors of up to 1,000 litres .)
Glovebox at Helsinn ’ s Biasca site
CEO Dr Mark Cassidy revealed that Ajinimoto Biopharma Services is in the midst of a global , three-year investment programme in capacities and capabilities . This , he said , has been driven by such familiar trends as sustainability , digitalisation , the need for simpler supply chains at a time of global crisis and unmet clinical needs in all areas . The investment includes debottlenecking the pilot plant to add a new HPAPI plant and filterdryer , as well as additional capacity for continuous photochemistry at the firm ’ s small molecule centre of excellence at Wetteren in Belgium , which operates at OEB 5 . This will be operational by October 2022 . As well as ADC capabilities , automation and a multi-purpose fillfinish line , a high-potency fill-finish line was added at the company ’ s centre of excellence for large molecules in San Diego in July , Cassidy added . Further investments are being made in midsized molecule capabilities , particularly oligonucleotides , at Ajinomoto ’ s other centre of excellence in Japan , and to double general API capacity by adding a second block at Vizag , India . Driven by the parallel trends of onshoring of API manufacture , increasing API complexity and sustainability in production , Evonik is expanding its cGMP plants at Hanau and Dossenheim in Germany , said Dr Stefan Randl , vice-president for research , development and innovation in Evonik Healthcare . The first stage , to 2024 , will see an investment of € 25 million . “ We will invest in new and nonstandard technologies to support the demand for complex APIs , particularly for oncology and antivirals ,” Randl said . As well as HPAPIs , these will include continuous processing , microbial fermentation , high potency PEG and MPEGs , chiral and carbohydrate chemistry , polymer APIs , and organometallic and cryogenic chemistry . •
22 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981