Tuesday, June 14, 2022 Daily Archives

Current Trends in Antibody Drug Conjugates (ADCs) Characterization: Expert Paper

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We bring you a brand-new paper focused on Current Trends in Antibody Drug Conjugates Characterization, focusing on structure. Comprehensive structural, biophysical, and physico-chemical property characterization in alignment with Chemistry, Manufacturing and Controls (CMC) guidance is a requirement to achieve successful regulatory (IND) submissions. Multiple analytical technologies are required for ADC analysis with a focus on the drug’s critical quality attributes (CQA), with data interpretation conducted by experienced biopharmaceutical analytical scientists. In this review, we discuss the current trends in antibody…

June 14, 2022

CO2 Transmission Into Bulk Drug Substance Containers

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Ingress of carbon dioxide into bulk drug substance (BDS) containers that are stored and shipped on dry ice is a serious and often understated problem. Bottles are a container of choice for freezing and shipping BDS due to their durability and convenience, compatibility with standard laboratory equipment, shelving and racking, and standard shipping containers. However, not all bottles are tested for CCI, nor does this testing guarantee leak-free performance once frozen. Carbon dioxide can readily enter bottles either through the…

June 14, 2022

ten23 to add two manufacturing lines at Swiss plant

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The expansion will see the ten23 Health add 5,000 square meters of space over four floors in Visp, Switzerland with the capacity to accommodate three manufacturing lines.  The Swiss contract development manufacturing organization (CDMO) has not disclosed financial details of the expansion at swissfillon’s manufacturing site located in Visp, canton of Valais, Switzerland, which the firm acquired in October 2021. However, ten23 confirmed the new facility in Visp-West will include two additional sterile manufacturing lines, offices, technical areas, and laboratories.…

June 14, 2022