Thursday, January 26, 2023 Daily Archives

Benefits of Real-Time Analytics to Overcome Common Cell Culture Challenges

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This webcast features: Nick Randall, Bioprocessing Product Manager, 908 Devices. Faster development cycles, intensified processes, and automation of process control are key initiatives in biotherapeutics manufacturing. However, offline analytics requiring manual intervention are commonly used to monitor critical and time-sensitive process parameters. We describe a new automated approach for optimal growth and production, leveraging sensitive, on-line (sample-free) monitoring of glucose and lactate with automated feed control, and its impact on growth/viability, lower toxic metabolite, and improved PQA. Key takeaways: Explore…

January 26, 2023

Lonza experiences CGT headwinds but hails pipeline for bounce back

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Lonza says a slowdown in funding and clinical trial issues in 2022 led to slower cell and gene therapy (CGT) sales growth compared to 2021. Contract development manufacturing organization (CDMO) Lonza reported sales of 6.2 billion CHF ($6.7 billion) in Q4 2022, a 15.1% sales increase on 2021. Its biologics division sales grew by 21.7% compared to 2021 and the firm’s CGT business sales increased by 13.6%. Lonza’s chief financial officer (CFO) Philippe Deecke attributed the smaller sales growth of…

January 26, 2023

CGT myth-busting: ‘The process is NOT the product’

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Deeper characterization and quality-by-design (QbD) approaches demonstrate the cell and gene therapy space has outgrown the lazy ‘process is the product’ rhetoric, say experts. Journalists and industry alike have clung onto the concept that ‘the process is the product’ when it comes to cell and gene therapies (CGTs). For years, the catchy phrase has been banded around convention centers and company boardrooms but as the field matures – 10 CGTs won approval in the US and Europe last year –…

January 26, 2023

TTP spins-out Cellular Origins to tackle CGT scalability

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Independent technology and product development company TTP  announced the launch of spin-out company Cellular Origins during Advanced Therapies Week in Miami, Florida. TTP launched Cellular Origins to develop a commercial manufacturing platform that will enable biopharmaceutical companies to increase scale dramatically for advanced cell and gene therapy (CGT) production, addressing the difficulties that developers have in meeting manufacturing demand. Matthew Carr, head of life sciences at TTP, said, “We have every confidence that Cellular Origins will deliver on its mission…

January 26, 2023

AGC builds on Provention partnership with diabetes mAb production

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AGC Biologics’ Bothwell, Washington site is commercially manufacturing Provention Bio’s type 1 diabetes (T1D) monoclonal antibody Tzield (teplizumab). Provention Bio said it selected AGC Bio to produce Tzield – the first authorized drug that can delay onset T1D –  after the contract development manufacturing organization (CDMO) supported the drug ahead of its approval by the US Food and Drug Administration (FDA) in November 2022. Tepilzumab is manufactured in two main stages: the upstream process followed by the downstream process,” Kevin…

January 26, 2023