Tuesday, November 6, 2018 Daily Archives

Singapore swing: Lonza transfers Tracon Ab to single-use plant

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CDMO Lonza has produced the first 2,000 L batch of Tracon Pharmaceuticals’ antibody TRC105 from its Singapore facility after transferring production from the UK. Californian biopharma firm Tracon has been using Swiss contract development and manufacturing organization (CDMO) Lonza for the manufacture of its lead candidate TRC105 (carotuximab) since the pre-clinical phase of development. The candidate is an antibody to endoglin – a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel…

November 6, 2018

Flow Cytometry News: Does your lab comply with 21 CFR Part 11?

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21 CFR Part 11 refers to the section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice), relating to the pharmaceutical and healthcare industries. Part 11 covers all FDA regulated issues pertaining to electronic records and electronic signatures. All computer systems that store…

November 6, 2018