海报

Kuhner TOM For Off-Gas Analysis in Shake Flasks

To facilitate and speed up process- and media development, online measurement techniques for shake flasks accompany manual sampling for maximum information output per cultivation. Off-gas analysis gives oxygen transfer rate (OTR), carbon dioxide transfer rate (CTR) and respiratory quotient (RQ) as quantitative measures of the physiological state of the culture. On shake flask scale, multiple cultivations are usually run in parallel. Off-gas analysis should therefore be cost effective, easy to handle and versatile to match various applications. Therefore, we developed…

Evaluation Of a New Glucose Control Strategy Using CITSens Bio APC (Automated Process Control) for CHO Fed-Batch Application

为了在研发中培养细胞,高细胞密度和可重复性是基本目标。对于这个目标,高度自动化有利于降低批次之间污染和偏差的风险。由于葡萄糖是细胞的主要能源之一,因此维持恒定和受控的自动葡萄糖供应至关重要。因此,Citsens Bio APC一个合并的系统来测量和控制细胞培养应用中的葡萄糖浓度是…

使用Octet™平台的GXP应用中的高生产率和过程经济

Using the label-free optical technique of Bio-Layer Interferometry (BLI), the Octet platform provides real-time analysis of molecular interactions. It relies on the robust and easy-to-use Dip and Read™ format, which provides faster time to results relative to technologies like ELISA and SPR. It also operates in a fluidics-free format, thereby minimizing the complexity in analyte detection by fluidics-based technologies like SPR. It provides high-throughput analysis, with the option of analyzing to 96 samples simultaneously, thereby increasing analytical productivity. It has…

通过完全集成的封闭CAR-T细胞治疗平台加速细胞和基因疗法的开发和制造

多年来,癌症治疗的主要形式一直是化学疗法,放射线和手术。正在研究一种惊人的突破,称为嵌合抗原受体(CAR)T细胞疗法在治疗各种类型的癌症中,包括急性和慢性淋巴细胞白血病,非霍奇金淋巴瘤,骨髓瘤和固体肿瘤。开发创新的先进疗法是我们大大改善患者生活的最大机会之一。Wuxi Advanced Thrapies最近宣布通过提供完全集成的服务来扩展其服务能力…

双特异性分子的结构和功能特征研究的表征平台

双特异性抗体(BSAB)与可能是不同的抗原或不同表位的两个或多个靶标结合。从结构上讲,一种类型的双特异性抗体与包含FC区域的IgG相似,而其他双特异性则没有FC区域,并且通常具有相对较小的分子量。因此,由于这种结构变化,双特异性的表征比典型的单克隆抗体更具挑战性。这里的海报讨论了一组平台…

在Beacon®平台上具有超过99%单克隆性的自动细胞系开发

对于所有commerci细胞株用于生产al therapeutics, FDA guidelines require assurance of monoclonality. This standard means that typical cell line development (CLD) campaigns often require multiple rounds of cloning easily spanning several weeks to months. However, Berkeley Lights, Inc. (BLI) has developed the ability to save time and money spent on CLD processes via automation. The uniquely powerful Beacon® optofluidic platform performs single-cell cloning, growth and titer measurements, and recovery of top clones with unrivaled (>99%) monoclonality…

用于治疗应用的高滴度重组慢病毒和腺相关病毒生产

Increase your recombinant lentivirus and adeno-associated virus (AAV) production with a novel transfection formulation, TransIT-VirusGEN® Transfection Reagent, specifically designed for large-scale virus production to support gene and cell therapies. This poster highlights TransIT-VirusGEN® for use in adherent or suspension cell culture platforms along with enhancers that significantly increase functional virus titers over PEI based formulations. Testing was performed with multiple serum-free media formulations and examined using different plasmid DNA concentrations to better address compatibility within various workflows. Download the poster…

在一次性袋中合格液体处理的新方法

2DFlexSAFE®袋和贝壳提供了强有力的验证:完整的后勤解决方案,用于在2DFlexSafe®袋和外壳质量中按照ASTM,NF和ISO等准则,在2DFlexsafe®袋和外壳质量中使用液体散装药物的质量进行了全面和创新的测试计划。允许安全可变运输量为标称填充量的10-120%,最终用户可以利用其自己的流程验证填写以下表格以查看完整的海报…

Antibody Affinity Extraction Enables Identification of Host Cell Proteins by Mass Spectrometry

Host cell proteins (HCP) constitute a major group of impurities for biologic drugs produced using cell culture technology. Even at nanogram per milligram concentrations of HCP to drug substance (DS), HCPs can elicit undesired immune response, interfere with drug safety and efficacy, or impact DS stability. A broadly-reactive HCP ELISA should be used during the purification processes to ensure removal of HCPs and to demonstrate process consistency and final DS purity. Regulatory authorities are requesting biopharmaceutical companies employ orthogonal methods…

Step-wise strategy to address process characterization and late phase development – toward the definition of a standardized approach

Drivers for process characterization and late phase development include improving process understanding, enhancing process robustness, and assurance that the process delivers consistent product quality within all Proven Acceptable Ranges (PARs). Regulator’s expectations for biologic submissions include the application of statistical methods to improve the confidence of the PARs and knowledge of the design space for a process. Different approaches have been reported for process characterization but contain common elements including risk assessment, scale-down model qualification, and statistical design of experiments.…