Thursday, October 21, 2021 Daily Archives

Cell Line Development: Accelerating Process Optimization by Combining Ambr® 15 Cell Culture with Octet® Titer Measurements

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Cell line development (CLD) involves the screening of thousands of clones to find those that are stable, produce high yields of the bioproduct and exhibit desired critical quality attributes (CQAs). Typically screening and process optimization activities will be carried out at the small scale in bioreactor cultures to ensure that results translate up to larger bioreactor scales. Performance data is primarily based on cell growth, cell viability, metabolite analysis and product titer, and assessed over the entire culture process duration.…

October 21, 2021

Novartis to make 24m doses of Pfizer vaccine from Slovenian plant

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Novartis will further support production of the Pfizer-BioNTech COVID-19 vaccine through fill-finish capabilities at its Ljubljana, Slovenia site. Earlier this year, Swiss pharma giant Novartis signed an agreement to provide aseptic manufacturing services from its Stein, Switzerland, to support the production of Pfizer and BioNTech’s COVID-19 vaccine. The arrangement was described at the time as part of the “unprecedented level of collaboration†occurring across the industry, and nine months on such collaboration continues, with Novartis signing a new agreement to…

October 21, 2021

ISCT partners to provide ‘urgent’ training programs for CGT workforce

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The International Society for Cell and Gene Therapy (ISCT) and the National Science Foundation (NSF) have partnered to provide training to upskill personnel. Led by the Georgia Institute of Technology, the global collaboration between ISCT and NSF’s Engineering Research Center for Cell Manufacturing Technologies (CMaT) aims to bridge the critical skills gap in the cell and gene therapy (CGT) industry by delivering educational programs. The joint-training program entitled ‘‘Workforce Development in Biomanufacturing – A Global Partnership with ISCT and CMaTâ€,…

October 21, 2021

J&J preps to enter cell therapy space as CAR-T approval decision approaches

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J&J says it will learn from pioneers in the cell therapy space as it preps its production network for the potential launch of its BCMA CAR-T product. J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell candidate specifically targeting the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China . Nearly four years on, and the…

October 21, 2021