NEWS
Two CDMOs in ADC expansions
Veranova has initiated a “ significant ” expansion of its antibody-drug conjugate ( ADC ) and highly potent compound development and manufacturing capabilities at Devens , Massachusetts , at a cost of about $ 30 million . The company said that this will address growing demand for strong US-based capacity for ADCs and other potent small molecules .
The expansion will include a new high potent process development laboratory and two new cGMP suites designed to handle potent compounds with OELs of < 0.01 µ g / m 3 . These will feature dedicated air handling systems , airlocks for clean-in-place operations , isolator technology and processing capabilities , including synthesis reactors , chromatography , thin film evaporators and lyophilisation .
Meanwhile , Sterling Pharma Solutions has likewise announced a $ 3 million investment in ADCs at its facility at Germantown , Wisconsin . It has commissioned a dedicated GMP suite , which will incorporate a modular isolator with containment capabilities down to less than 1 ng / m 3 .
The isolator can manufacture toxin linkers at up to kilogram scale , which can then be transferred to its dedicated facility for ADCs at Deeside , UK , for the development and finalphase GMP conjugations of ADC drugs . This will also facilitate weighing , dispensing and dissolving of reagents within a fully contained environment .
Additional modules for automated flash , and high-pressure chromatography under a range of normal and reverse-phase conditions , as well as in-process analysis of products have also been installed . A further module , which will allow
ADC production at Germantown
lyophilisation of up to 30-litre batches at -85 ° C , is currently being commissioned .
Sterling has also just commissioned a 210 m 2 bioanalytical laboratory at Deeside . This will provide support for ADC method development projects , plus stand-alone services for biologic drug products and drug substances . It has instruments for the development of release assays for antibodies and other biomolecules , including chromatographic , electrophoretic , UV and ELISA-based techniques .
Elkem to pilot CO 2 -free silicon production
Enova , a state enterprise owned by the Norwegian Ministry of Climate & Environment , has granted Elkem € 2.7 million to build a medium-scale pilot facility at its site in Kristiansand . This will test a new concept Elkem is researching to eliminate almost all direct CO 2 emissions from silicon manufacture . The ultimate aim is to industrialise the process in the 2030s .
In the Sicalo ( Silicon production with carbon looping ) process , the emitted carbon used to produce silicon from quartz in the furnace is captured and reused as a reductant . The first phase of R & D in which the various sub-processes are being tested at laboratory and bench scales with SINTEF Industry and NORCE , is about to be completed .
Elkem ’ s silicon production is based on more than 80 % emission-free electricity and is claimed to be one of the world ’ s most sustainable processes in the industry . Hitherto , however , the emissions from the carbon used have been much harder to abate . The company completed the world ’ s first carbon capture pilot in a silicon smelter in 2023 , with capture rates of up to 95 %.
Testing the concept at Elkem
JUL / AUG 2024 SPECCHEMONLINE . COM
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