Friday, August 12, 2022 Daily Archives

Small Samples, Big Discoveries: Characterizing AAV Aggregates at Low Volumes and Identifying Their Root Causes

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Gene therapies that use AAVs have shown great promise, but can be unstable due to their fragile composite DNA/protein nature, which presents an analytical challenge when determining root cause of subvisible particle (SVP) formation and product instability. Understanding how these proteins interact with leaked payloads will allow better insight into avoiding aggregate buildup. Yet, this has been difficult, hampered by legacy systems that cannot conduct low volume SVP analysis or interrogate for DNA content. That’s about to change. In one…

August 12, 2022

Best Practices in Mycoplasma Testing for Cell and Gene Therapies

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This webcast features: Kajal Brahmbhatt, Director of QC Analytical Services, WuXi Advanced Therapies. Mycoplasma bacteria frequently and easily contaminates cell cultures and can have devastating effects on the manufacture of cell and gene therapies. To avoid extensive destruction of product batches and delayed provision of treatment to patients, it is critical that robust mycoplasma testing processes are implemented. In this webinar, learn best practices for mycoplasma testing, helping innovators to plan their strategy for cell and gene therapy development. Key…

August 12, 2022

Lilly working ‘around the clock’ to ensure Mounjaro supply

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Two US drug substance and two drug product manufacturing plants are in the works to support the rollout of Eli Lilly’s recently approved type 2 diabetes GLP-1 receptor Mounjaro (tirzepatide). In May, the US Food and Drug Administration (FDA) approved Mounjaro, a once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor. Mounjaro represents the first new class of type 2 diabetes medication introduced in almost a decade, and a boost for developer Eli Lilly, which has begun rolling out…

August 12, 2022

Tosoh to increase media capacity by 70% at Japan plant

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Tosoh Bioscience aims to meet the increased demand for separation and purification media by investing $120 million to expand its Nanyo Complex in Shunan City, Japan. According to Tosoh, separation and purification media are critical products of its bioscience division, which are required in the purification process of biopharmaceutical production and various other processes. The firm noted that one of the most important applications is the purification of antibody-derived molecules. Meanwhile, demand for RNA-based vaccines and drugs, other modalities, and…

August 12, 2022

Podcast: Turning out talent and the trials of training in the bioprocess space

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Training, virtual reality, and uptake in courses are all critical factors that need to be addressed to meet the demand for talent in the advanced therapy space, according to industry academics. This episode of the BioProcess Insider Expression Platform (BIEP) podcast brings you an in-depth conversation with Stuart Curbishley, head of business and project development, advanced therapies at University of Birmingham and Ivan Wall, CEO, Four-Plus and director of the National Training Center for advanced therapies manufacturing. We delve deep into…

August 12, 2022