mAbs Downstream
Products for Development and Manufacturing
Higher cell densities and antibody titers from increasingly advanced upstream processes result in complex downstream purification challenges. The focus of downstream bioprocessing is efficient recovery and purification while controlling bioburden and assuring viral safety to provide drug safety for patients. The downstream workflow, which includes clarification, chromatography, concentration, viral clearance, and sterile filtration steps, is essential for ensuring monoclonal antibody (mAb) product quality, yield, safety, and sterility.
Concentration and Diafiltration (UF/DF)
Tangential flow filtration (TFF) including ultrafiltration (UF) and diafiltration (DF) are used throughout monoclonal antibody (mAb) production, to remove process chemicals, exchange buffers, reduce volumes and concentrate drug substance. These steps improve yields and enable formulation at the high concentrations necessary for subcutaneous administration of drug product.
Key considerations for any TFF operation include maximizing the capacity of filtration device and molecule recovery. Additionally, with higher molecule concentrations, strategies for managing increased aggregation and viscosity must be implemented.
Single-pass tangential flow filtration (SPTFF) is increasingly being implemented in intensified and continuous processes to reduce in-process volumes either before or after column chromatography, or before formulation.
To help you overcome your UF/DF challenges, we provide the following solutions:
- Millipore® TFF Devices (cassettes, capsules, SPTFF)
- Millipore® Buffer Filtration
- Millipore® Single-Use and Multi-Use Solutions (systems & holders, connectors) from Bench to Process-Scale
- SAFC® Pharma Raw Materials (buffers, salts, stabilizers, CIP solutions, viscosity reduction platform, liquid buffers)
- Millipore® Services (single-use and filter validation, equipment installation, system qualification, system training, system services)
- Millipore® Automation and Analytics Software
Related Categories
Our broad portfolio of buffer materials manufactured under appropriate controls is tailored to your needs.
Clarification steps prepare your bioreactor harvest material for downstream purification by reducing the levels of impurities and particulates.
Downstream purification in bioprocessing includes one or more chromatographic separation steps to purify your molecule and remove impurities.
Our broad portfolio of membrane filters offers options for efficient processing of every pharma and biopharma stream.
Our viral clearance portfolio includes the virus filtration solutions, chemicals, holders and systems.
Ultrafiltration & diafiltration increase capacity, concentration, and recovery in bioprocessing.
Related Resources
- 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.
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