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.
Polishing Chromatography
Ion exchange chromatography (IEC or IEX) is used in downstream processing to further purify monoclonal antibodies (mAbs) from product and process-related impurities, and viruses. Cation exchange (CEX) chromatography removes DNA, endotoxins, host cell proteins (HCPs), and leached Protein A ligands from the mAb feedstream. This step can also help reduce mAb aggregates. Anion exchange (AEX) chromatography removes trace contaminants such as nucleic acids and HCPs and can also contribute to virus clearance. Besides cation and anion exchangers, hydrophobic interaction chromatography (HIC) or mixed mode/multimodal chromatography can also be deployed in this polishing step. To optimize chromatographic separation and quickly evaluate media performance, high throughput screening (HTS) using pre-packed mini or robotic columns can be used. Both, resin (conventional beads) and membrane (adsorbers) formats, can be used for these applications.
For these polishing steps, we offer the following solutions:
- Millipore® Resins & Membranes
- Bioreliance® Contract Testing Viral Clearance Testing
- Millipore® / SAFC® Buffer Filtration and Preparation
- Millipore® Single-Use and Multi-Use Chromatography Systems and Columns
- SAFC® Pharma Raw Materials (buffers, salts and stabilizers, CIP solutions)
- 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
- Chromatography Purification Selection Guide
A guide to select your chromatography resins.
- Development Strategy for a Cation Exchange (CEX) Chromatography Step in a Monoclonal Antibody (mAb) Process
The aim of this technical note is to provide a description of the steps followed and considerations taken during the development of a CEX chromatography step in a mAb process.
- Viral Clearance in Antibody Purification Using Tentacle Ion Exchangers
Manufacturers strive toward cost-effective purification of target molecules and a high level of confidence that their biologics are safe and not compromised by the presence of endogenous retrovirus-like particles or adventitious viruses.
- Intensified Polishing Using Single-pass Tangential Flow Filtration (SPTFF) with Anion Exchange Chromatography
The bioprocessing industry is interested in Next Generation Processes with higher flexibility, lower costs, and higher product quality.
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