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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >VIRAL CLEARANCE VALIDATION FOR A FULLY CONTINUOUS MANUFACTURING PROCESS FOR PHASE 1 STUDIES
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VIRAL CLEARANCE VALIDATION FOR A FULLY CONTINUOUS MANUFACTURING PROCESS FOR PHASE 1 STUDIES

机译：阶段1研究的全连续制造过程的病毒清除验证

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摘要

Over the past years, BiosanaPharma has developed a fully continuous process for the manufacturing of antibodies. The objective is to have a continuous production platform for biosimilars. Recently, a phase 1 study was initiated for a biosimilar that was produced using this continuous platform. Using high cell density perfusion, two BioSMB (chromatography) steps, continuous nanofiltration and UFDF, a production campaign was performed under GMP to produce multiple drug substance batches. Given some unorthodox design choices, validation of the viral clearance capacity of this continuous process revealed some interesting challenges. The viral clearance validation focused on three steps: low pH virus inactivation, a membrane anion exchange step and nanofiltration. In this talk, justification for the scale down model is presented alongside with the results of the viral clearance study to demonstrate the safety of the product for a phase 1 study.
机译：在过去的几年中，BiosanaPharma开发了一种完全连续的抗体生产工艺。目的是为生物仿制药提供一个连续的生产平台。最近，开始了使用该连续平台生产的生物仿制药的1期研究。使用高细胞密度灌注，两个BioSMB（色谱）步骤，连续纳滤和UFDF，在GMP下进行了生产活动，以生产多个批次的原料药。考虑到一些非常规的设计选择，对该连续过程的病毒清除能力的验证显示出一些有趣的挑战。病毒清除率验证的重点在于三个步骤：低pH值病毒灭活，膜阴离子交换步骤和纳滤。在本次演讲中，将介绍按比例缩小模型的合理性以及病毒清除研究的结果，以证明该产品在1期研究中的安全性。

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