下游 mAbs

开发和制造产品

越来越先进的上游工艺所产生的更高细胞密度和抗体滴度带来了复杂的下游纯化挑战。下游生物处理的重点是高效回收和纯化，同时控制生物负荷并确保病毒安全性，从而为患者提供安全的药物。下游工作流程包括澄清、层析、浓缩、病毒清除和无菌过滤步骤，对于确保单克隆抗体 (mAb) 产品的质量、产量、安全性和无菌性至关重要。

下游处理

病毒过滤

浓缩和渗滤

浓缩和渗滤（UF/DF）

切向流过滤（TFF）包括超滤（UF）和重滤（DF），在单克隆抗体（mAb）生产过程中被广泛使用，以去除工艺化学品、交换缓冲液、减少体积并浓缩药物物质。

任何 TFF 操作的主要考虑因素包括最大限度地提高过滤设备的容量和分子回收率。

单程切向流过滤（SPTFF）正越来越多地应用于强化和连续工艺中，以减少柱层析前后或配制前的工艺中体积。

为帮助您克服 UF/DF 面临的挑战，我们提供以下解决方案：

Millipore^® TFF设备（盒、胶囊、SPTFF）
Millipore^® 缓冲液过滤
密理博单用途和多用途解决方案（系统和支架，连接器。从工作台到工艺规模）
SAFC^® 制药原料（缓冲剂、盐、稳定剂 , CIP 解决方案 , 降粘平台, 液体缓冲剂）
Millipore^® ；服务（一次性使用和过滤器验证、设备安装、系统鉴定、系统培训、系统服务）
密理博^® 自动化和分析软件

相关资源

Tangential Flow Filtration in Downstream Bioprocessing
This article explains the different types of TFF, including single-use and multi-use, single pass TFF and batch TFF.
Single-Pass Tangential Flow Filtration Implementation and Scaling
This article discusses how to implement and scale-up SPTFF using Pellicon^® Capsules.
White Paper: Streamlining Bioprocessing Using Pellicon^® Cassettes for Single-pass Operation
Single-pass TFF is an enhanced approach to the existing TFF technology that has been used for the purification of monoclonal antibodies, therapeutic proteins, and vaccines at different steps within downstream processing.
Application Note: Pellicon^® 3 Cassettes with High Viscosity Feed Screen
Pellicon^® 3 Cassettes with Ultracel^® and Biomax^® 30 kD Membrane utilizing D screen geometry are engineered to efficiently process higher viscosity products.
Application Note: Process Optimization and Scalability Evaluation of Pellicon^® Capsules for Single-pass Tangential Flow Filtration of mAb-Based Biomolecules
Single-pass tangential flow filtration (SPTFF) is a method of ultrafiltration that is used to either reduce volume or increase protein concentration.
Application Note: Pellicon^® Capsules for Single-use Tangential Flow Filtration
The Pellicon^® Capsule is the first of its kind—a true single-use TFF device that streamlines bioprocessing with its innovative, simplified design and user-friendly features.
Application Note: Running a TFF optimization study with Cogent^® Lab Systems and Bio4C^® Control Software
This application note describes the recommended methods and techniques for optimizing a tangential flow filtration (TFF) process using a Cogent^® Lab system.
Brochure: Process Development and Drug Manufacturing: Support Services
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.