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Despite hitting a speed bump over the summer, automated cell therapy manufacturing specialist Cellares has continued to sign new partners at a steady pace, now inking a second agreement with an Asia-based organization in just over a week. The latest tie-up will see Cellares, which positions itself as an integrated development and manufacturing organization (IDMO), link arms with Seoul National University Hospital (SNUH) in South Korea. Under the accord, for which financial details were not disclosed, the partners will assess whether SNUH’s gene-modified hematopoietic stem and progenitor cell (HSPC) manufacturing process can be translated to the Cell Shuttle, Cellares’ automated platform for cell therapy production. In particular, SNUH, a translational medical center in South Korea’s capital, will assess the tech on an investigational cell therapy targeting paroxysmal nocturnal hemoglobinuria (PNH). The production trial will incorporate a two-step transfection workflow using the integrated electroporator in Cellares’ Cell Shuttle configuration, CEO and co-founder Fabian Gerlinghaus said in an interview. Electroporation uses electrical pulses to temporarily create openings in cell membranes, while transfection refers to the process of introducing genetic material or other substances into cells. In Cellares’ setup, the company’s electroporator is integrated into a single-use cartridge, automating multiple steps in the manufacturing process. The cartridge moves through the Cell Shuttle, which Gerlinghaus has previously referred to as “basically a lab in a box.” In testing SNUH’s manufacturing process on the Cell Shuttle, the partners are aiming to establish an automated production strategy that could underpin future U.S. clinical development of the Korean hospital’s PNH candidate, the Cellares CEO said. Meanwhile, the emphasis on transfection and electroporation echoes the deal Cellares struck with Taiwan’s GenomeFrontier Therapeutics last week, with Gerlinghaus noting that both outfits’ non-viral cell therapy programs “require sophisticated electroporation workflows, which is, I’d say, one of the key areas where the cell shuttle is strongly differentiated in terms of capabilities.” The Cell Shuttle, according to the Cellares helmsman, “is the only end-to-end cell therapy manufacturing platform that has onboard electroporation abilities and is proven in the clinic,” highlighting his company’s first-in-patient dosing milestone earlier this year as a “proof point.” That dosing milestone with partner Cabaletta Bio in April has also had the added benefit of helping more than double Cellares’ customer base since the start of the year, Gerlinghaus said. As Cellares builds up its roster of partners, the IDMO’s ultimate commercial manufacturing trajectory will likely be a “numbers game,” Gerlinghaus said. While “not everyone is going to cross the finish line,” Gerlinghaus noted that Cellares has “signed a dozen customers this year.” “We expect to keep going at this rate,” he continued, “and build a really sizable portfolio of cell therapy companies on our platform and ultimately get a handful of drugs across the finish line to commercial manufacturing.” The CEO espoused that continued confidence as Cellares comes off a setback over the summer, when the loss of a “large pharmaceutical customer” prompted a series of layoffs in California and New Jersey . The partner was ultimately revealed to be Bristol Myers Squibb, which inked a deal in 2024 for Cell Shuttle capacity that was worth up to $380 million at the time. But “BMS was only one customer out of many,” Gerlinghaus said, noting that the pharma has subsequently “made some public statements that we have publicly disagreed with strongly.” “Specifically,” the CEO said, his company disputes “the BMS characterization that the Cell Shuttle could not meet the requirements for commercial Breyanzi manufacturing,” referring to the pharma’s approved CAR-T therapy. BMS has said its determination was specific to Breyanzi and its existing regulatory-approved manufacturing process, rather than a broader assessment of the Cell Shuttle platform. Gerlinghaus stressed, citing the company’s own comments, that BMS’ determination was specific to that CAR-T cell therapy. Moreover, the BMS program “ended before we generated comparability data that was sent to the FDA, so the FDA actually never made a comparability determination on Breyanzi," Gerlinghaus explained. “Ultimately, BMS terminated the partnership before we could complete the work.” Still, Cellares doesn’t appear to be letting the situation rattle its confidence. In terms of the company’s overall trajectory moving forward, “the strategy really remains unchanged,” Gerlinghaus said.

CellSeal冻存管：CellSealClosed-SystemCryogenicVials（SEXTONCELLSEAL冻存管）是在符合ISO13485认证质量体系的清洁、受控的制造环境中制造的，用于样品的低温冻存。产品构造概述：Sexton冻存管为空管，内部具有无菌、非致热的液体路径，适用于单次使用，主要用于GxP环境的研究，例如GMPZui终产品制造。结构组成：SEXTONCELLSEAL冻存管由瓶体、相关管道和三个端口组成：一个填充口、一个带盖的提取口和一个带微生物屏障的通气孔。严格的质控保障了产品的可靠性，为科研工作提供了稳定的实验基础。Sexton的冻存盒与CellSeal无菌全密闭冻存管完美搭配，兼容2ml和5ml冻存管，每盒64支。采用聚丙烯材质，耐低温，方便清洗。组件拆卸方便，确保冻存系统的整洁与高效。上海曼博生物是SextonBiotechnologies在中国地区的官方指定代理商，如想购买Sexton细胞冻存管、细胞灌装系统等相关产品，欢迎咨询！CellSeal用途-细胞制剂的药包材容器（直接接触药品的包装容器）。Sexton冻存管DMF Sexton公司成立于2014年，是生命科学孵化器/加速器CookRegentec的衍生产品。Sexton Biotechnologies 是一家收入阶段的生物技术公司，专注于开发和销售用于细胞和基因zhi liao的生物生产工具。Sexton冻存管：材质优越，保障样本稳定性。Sexton冻存管采用you zhi材料，经过精密设计，保障样本完整性。适配器专为穿透CellSeal Vial的隔膜设计，尽可能确保回收率。这种管子不*结构坚固，还能满足细胞与基因zhi liao领域对样本质量的高要求。Sexton的冻存盒与CellSeal无菌全密闭冻存管完美搭配，兼容2ml和5ml冻存管，每盒64支。冷冻冻存管使用方法有人知道冻存管的价格吗？ SextonBiotechnologies是一家收入阶段的生物技术公司，专注于开发和销售用于细胞和基因zhiliao的生物生产工具。Sexton公司成立于2014年，是生命科学孵化器/加速器CookRegentec的衍生产品。Sexton开发了专门构建的细胞和基因zhiliao(CGT)工具和培养基产品，以实现细胞制造过程的灵活自动化和规模化，以增加获得积极临床结果的可能性，并减少上市时间、故障点和劳动力成本。Sexton冻存架：不锈钢材质，耐受极低至较高温度。Sexton的冻存架专为冻存盒设计，主要分为4层和5层两种款式。采用不锈钢材质，耐受温度范围从-196℃到121℃。架面清洁便捷，确保样本在极端温度下的稳定存储。 Sexton冻存管：材质优越，保障样本稳定性。Sexton冻存管采用youzhi材料，经过精密设计，保障样本完整性。适配器专为穿透CellSealVial的隔膜设计，尽可能确保回收率。这种管子不*结构坚固，还能满足细胞与基因zhiliao领域对样本质量的高要求。Sexton的冻存盒与CellSeal无菌全密闭冻存管完美搭配，兼容2ml和5ml冻存管，每盒64支。采用聚丙烯材质，耐低温，方便清洗。美国Sexton品牌CellSeal无菌冷冻冻存管主要特点如下：•CellSeal用途：细胞制剂的Zui终药包材容器（直接接触药品的包装容器）•CellSeal结构设计：CellSeal无菌冻存管精密设计，结合了冻存袋和硬瓶的优点，为满足细胞zhiliao行业需求而生；•CellSeal选材考究：美国药典Zui高等级的医用塑料USPClassVI，选材考究，耐低温、耐DMSO、抗断裂；•CellSeal药包材测试清单齐全：批次放行测试清单、设计测试项目清单以及其他冻存管制造过程控制等清单•CellSeal全球已有IND和BLA案例丰富：十几个国家40多种IND药物，2个上市药物（一个是中国，一个在美国）上海曼博生物是SextonBiotechnologies在中国地区的官方指定代理商，如想购买Sexton细胞冻存管、细胞灌装系统等相关产品，欢迎咨询！哪里可以购买冻存管？ 美国Sexton Biotechnologies专注于细胞和基因zhi liao行业生产工具的开发和销售，开发了适用于CGT行业生产的工具和产品，以实现细胞制造过程的灵活自动化和规模化，从而提高临床结果成功的概率，减少上市时间和劳动力成本。美国Sexton品牌CellSeal无菌冷冻冻存管是可作为生物制剂药包容器用于储存和运输生物制剂的一种封闭系统低温存储设备。与市场上已有的对照产品-康宁冻存管相比，CellSeal冻存管中细胞的冷却和解冻速度以及解冻后的存活率等关键参数并无明显差异。Sexton的冻存盒与CellSeal无菌全密闭冻存管完美搭配，兼容2ml和5ml冻存管，每盒64支。采用聚丙烯材质，耐低温，方便清洗。组件拆卸方便，确保冻存系统的整洁与高效。Sexton冻存管：材质优越，保障样本稳定性。Sexton冻存管采用youzhi材料，经过精密设计，保障样本完整性。适配器专为穿透CellSealVial的隔膜设计，尽可能确保回收率。CellSeal选材考究：美国药典高等级的医用塑料USP Class VI，选材考究，耐低温、耐DMSO、抗断裂。天津冻存管安全性数据 Sexton品牌CellSeal无菌冷冻冻存管已在十几个国家40多种IND药物，2个上市药物（中国及美国）。Sexton冻存管DMF Sexton的细胞和基因zhiliao生物生产工具组合包括：•CellSeal封闭系统无菌冷冻冻存管，其中包含有利于zhiliao制造商的多种差异化功能；目前被纳入美国FDA批准的来自百时美施贵宝的CAR-T细胞疗法Breyanzi和其他全球几十项细胞疗法正在临床试验中。•nLivenPR、T-LivenPR和Stemulate人血小板裂解物(hPL)培养基产品，这些产品是细胞zhiliao体外扩增培养补充剂，旨在满足zhiliao企业用户性能和全球监管期望。•AF-500自动灌装设备，用于中间和Zui终细胞zhiliao产品的高通量灌装系统。•SignataCT-5，这是diyi个真正灵活的用于细胞zhiliao处理和灌装填充的流体管理系统。程序降温盒：智能化的样本冷冻过程：Sexton的程序降温盒简化了样本冷冻过程。无需添加醇类等添加剂，在-80℃冰箱中放置4小时即可转移样本。兼容2ml和5ml冻存管，每次可处理12支，降温速率为1℃/min，保障样本冷冻的均匀性与稳定性。Sexton冻存盒：完美配合CellSeal无菌全密闭冻存管。Sexton的冻存盒与CellSeal无菌全密闭冻存管完美搭配，兼容2ml和5ml冻存管，每盒64支。Sexton冻存管DMF