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.
Affinity Chromatography
Protein A affinity chromatography is a robust, highly selective purification step that effectively captures monoclonal antibody (mAb) molecules separating them from impurities in complex clarified harvest material. This results in efficient mAb purity and recovery.
Consistent purification performance is required at all scales, from process development to production, and should be maintained through the long resin lifetime for optimized process economics.
For intensified or continuous processes, multi-column capture chromatography offers an effective approach to affinity separation which leverages the benefits of familiar protein A technology while reducing bottlenecks and increasing productivity.
Overview of our Protein A affinity chromatography portfolio for your capture purification challenges:
- Millipore® Affinity Chromatography Resins
- Millipore® / SAFC® Buffer Filtration & Preparation
- Millipore® Chromatography Systems & Columns
- SAFC® Pharma Raw Materials (buffers, salts and stabilizers, CIP solutions)
- Millipore® / BioReliance® Services (single-use and filter validation, viral clearance & safety, 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
- What is multi column chromatography?
In this article, we will discuss one of the methods used to intensify the capture chromatography process: multi column chromatography (MCC).
- Application Note: Multi-Column Capture
Prototype Tests for Monoclonal Antibody Capture During Project nextBioPharmDSP (Horizon 2020).
- Chromatography Purification Selection Guide
A guide to select your chromatography resins.
- Data Sheet: Eshmuno® A Resin
Eshmuno® A media is a rigid, high-capacity, acid and alkaline resistant Protein A affinity chromatography media for the purification of Fc-containing proteins, including but not limited to monoclonal antibodies.
- Application Note: Increase your Eshmuno® A resin lifetime with Ethylene Glycol Emprove® Evolve
Sodium hydroxide (NaOH) is a standard cleaning agent for protein A chromatography resins. Typically, a concentration of 0.1 mol/L NaOH is used. The inclusion of 20% ethylene glycol in a 0.1 mol/L NaOH cleaning solution increases the lifetime of Eshmuno® A columns significantly.
- Application Note: Detection and Quantification of Leached Protein A from Eshmuno® A Resin Using Cygnus F400 Protein A ELISA Kit
This app note describes qualification and successful implementation of the Cygnus Protein A ELISA Kit (Cat# F400) for quantitation of residual Eshmuno® A protein A resin in bioprocessing intermediate samples.
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