使用稳定的生产者HEK293细胞对病毒载体制造的细胞系
基因和细胞疗法工作流程经常利用稳定的生产者HEK293 / 293T细胞在生物载体的生产中，是先进治疗药品（ATMPS）的一个例子。188金宝搏亚洲真人与瞬态转染方法相比，稳定的生产者线可以提供更可扩展，更高的滴度的生产方法，提供改进的批量批量一致性，并且还可以是2018年FDA草案指南中所述“用于测序材料”的源。
Seeding and Evidence of Clonality with HEK293 Cells
The 2020 FDA guidance on CMC and INDs for cell and gene therapy spoke to both regulators and manufacturers looking to standardize best practices around viral vector production workflows. This includes avoiding the use of animal-derived reagents and using assurance of clonality as part of production quality control was highlighted.
Incorporate the Solentim VIPS™ for high efficiency single cell seeding and in-well verification by imaging and Cell Metric® for Day 0 single cell assurance and outgrowth imaging into your workflow.
增加克隆的过度生长，并通过我们的无动物试剂，Instigro，InsteShakeake和Insthotaw来保护细胞在冷冻和解冻时为HEK细胞进行免受保护细胞。
用渗透压提高产量
Consistency is critical throughout gene therapy vector production for therapeutics, including viral vector delivery and gene editing. Small deviations in the composition of cell growth media can have unwanted effects on cell density, cell composition, and virus yield.
渗透can help you meet these goals as well as optimize the physiological range for transfection complexes, identify media needs, and determine the effects of osmotic pressure on the stability of a complex.
Delivering Assurance For Viral Vector Production
The 2020 FDA guidance on CMC and INDs for cell and gene therapy spoke to both regulators and manufacturers looking to standardize best practices around viral vector production workflows. This includes avoiding the use of animal-derived reagents and using assurance of clonality as part of production quality control was highlighted.
With the OsmoTECH XT, we are able to test 20 microliter samples. Other osmometers have a sample volume of 100 microliters, which doesn’t seem like a lot. But when you are in the cell and gene therapy field, where you are working on therapies that will go into patients right away, or you are doing patient samples, you want to use the smallest sample possible.
Kayla Pasake, Research Associate for Analytical Development at The Center for Breakthrough Medicines
Popular Educational Resources
了解更多about how our technologies can be utilized to help accelerate your gene therapy vector production by checking out our educational resources below
Application Note
Clonality and improved outgrowth for HEK 293 cells when developing stable producer cell lines for viral vector production in gene therapy.
Associated Products
Osmotech.®XT Single-Sample Micro-Osmometer
Best-in-class osmolality performance, designed for the toughest samples
Solentim VIPS™
High efficiency, high viability single cell cloning for cell line development and cell therapy
Next Generation Cell Culture Growth Supplements
Animal component-free cell culture supplements for CHO and HEK cells
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