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May 2024 Featured Report
A cell line development engineering and development featured report
As director of biological content at the ATCC, Fang Tian oversees the preparation, authentication, characterization, quality control, and cryopreservation of more than 3,400 accessioned animal cell lines and hybridomas in the nonprofit organization’s cell-biology general collection. She has been with ATCC for 12 years, during which she served as a scientist and head of cell-biology research and development. Previously she was a research fellow at Harvard Medical School’s Massachusetts General Hospital, where she studied signaling pathways, working with high-throughput, real-time polymerase chain reaction (PCR) screening to study cell death and stress in oncology. Tian did her postdoctoral work at the University of Pittsburgh Cancer Institute after earning her PhD in pharmacology from the Chinese Academy of Sciences.
In April 2024, BPI associate editor Josh Abbott spoke with Tian about the importance of authentication to developing cell lines for biopharmaceutical discovery, production, and testing.
The Im...
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New genetic-engineering techniques, analytical methods, and laboratory technologies are helping to elucidate the inner workings of mammalian and other cells to an extent once never imagined. Cell biologists and process engineers now have an unprecedented ability to refine and control performance in cell cultures. Along with advanced information technologies (ITs), those successes already are changing how biopharmaceutical companies around the world undertake cell-line development (CLD). This past March 2024 at BPI West in San Diego, CA, an entire conference track was devoted to reports of such progress.
Keynotes and Featured Presentations
Key talks from “big-pharma” and academic speakers highlighted advances in digitalization, manufacturing technologies, and genetic modification. In “Digital Transformation: Accelerating Process Development and Enhancing Control Strategies,” Tiago Matos (associate principal scientist at Merck) explored the concept of digital twins for biomanufacturing facilities, highlight...
Sequence variants are amino-acid substitutions that can influence biopharmaceutical efficacy and immunogenicity
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. Sequence variants could be considered as product-related impurities — molecular variants arising during manufacture and/or storage that have properties incompatible with those of a desired product with respect to activity, efficacy, and safety — as outlined in ICH Q6B and related regulatory guidances. Genetic mutation and amino-acid misincorporation are two major sources of sequence variation during protein production
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. In a survey of experts from the biopharmaceutical and biotechnological industries coordinated by the International Consortium for Innovation & Quality in Pharmaceutical Development (IQ), 67% of respondents considered genetic mutation to be the larger of those two concerns. It cannot be mitigated by culture process optimization, and mutation levels are likely to change over cell passaging because of Chinese hamster ovary (CHO) cells’ genomic plasticity
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Per regul...
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