Nanomosaic published a scientific

Nanomosaic发表了一篇科学论文

white paper

白皮书

detailing a study conducted with Bristol Myers Squibb (BMS) that explores the potential of nanoneedle technology as a tool for advancing the understanding of adeno-associated virus (AAV) manufacturing processes and product quality.

详细介绍了与百时美施贵宝（BMS）进行的一项研究，该研究探索了纳米针技术作为促进对腺相关病毒（AAV）制造过程和产品质量的理解的工具的潜力。

During AAV production, natural variations in the viral genome lead to the formation of subpopulations within a single batch. These variations can negatively impact the efficiency of the vector, potentially compromising therapeutic efficacy or causing unintended side effects due to suboptimal AAV subpopulations..

在AAV生产过程中，病毒基因组的自然变异导致在单个批次内形成亚群。这些变化可能会对载体的效率产生负面影响，可能会影响治疗效果或由于次优的AAV亚群而引起意外的副作用。。

The NanoMosaic system is comprised of two parts: the instrument, Tessie, and the Nanoplate consumables. Tessie is a fully automated plate reader that accepts the Nanoplates, performs the image acquisition, and uploads the data to a cloud-based image processing platform, according to the company. [Nanomosaic].

纳米镶嵌系统由两部分组成：仪器，Tessie和纳米板耗材。。[纳米马赛克]。

To mitigate these risks, AAV developers and manufacturers implement strategies to selectively enrich preparations with particles containing a complete transgene capable of delivering the desired therapeutic effect.

为了减轻这些风险，AAV开发人员和制造商实施了策略，用含有能够提供所需治疗效果的完整转基因的颗粒选择性地富集制剂。

“The nanoneedle technology offers a unique capability to simultaneously quantify titers of true, full viral genomes as well as a range of partial species, making it an invaluable tool for the next generation of process optimization,” said Daniel Hurwit, senior principal scientist, BMS. “By accurately and quantitatively distinguishing between sub-species of particles and providing a true readout of full-length genomes, the technology enables an improved approach to understanding manufacturing performance and product quality.”.

“纳米针技术提供了一种独特的能力，可以同时量化真实的全病毒基因组以及一系列部分物种的滴度，使其成为下一代过程优化的宝贵工具，”BMS高级首席科学家丹尼尔·赫维特（DanielHurwit）说。“通过准确和定量地区分颗粒的亚物种并提供全长基因组的真实读数，该技术可以改进理解制造性能和产品质量的方法。”。

The study demonstrated that the nanoneedle technology can effectively quantify AAV subpopulations, offering critical insights into the production of full-length vectors, according to Hurwit. It also identified pools of partial genomes that may persist in AAV feed streams, addressing major limitations in traditional methods, such as ITR-based tittering, which can misrepresent viral genome content, he continued.

据Hurwit称，这项研究表明，纳米针技术可以有效地量化AAV亚群，为全长载体的生产提供了重要的见解。他继续说，它还确定了可能持续存在于AAV饲料流中的部分基因组库，解决了传统方法的主要局限性，例如基于ITR的滴定，这可能会歪曲病毒基因组的含量。

“With just 2 L of sample, this scalable, high-throughput assay can be applied to a wide range of matrices, from crude lysates to purified vectors, enabling more precise monitoring and optimization throughout the AAV manufacturing process,” added Qimin Quan, PhD, co-founder and CSO, Nanomosaic..

“仅需2 L样品，这种可扩展的高通量测定法就可以应用于从粗裂解物到纯化载体的各种基质，从而能够在整个AAV制造过程中进行更精确的监测和优化，”Nanomosaic联合创始人兼CSO Qimin Quan博士补充道。。

News

新闻