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.
Clarification
Clarification, both primary and secondary, is used to separate secreted monoclonal antibodies (mAbs) from whole cells, colloids, aggregated and non-product proteins, lipids, and large particles in the cell culture fluid harvest. More than one clarification step is typically required for removal of these impurities and to prepare the feedstream for further downstream purification. Various types of pre-treatments (e.g., precipitation/flocculation) are increasingly employed as effective methods to clarify high density cell cultures and to make the clarification process more efficient. Centrifugation, depth filtration, and sterile filtration are the most common approaches to clarify mammalian cell harvest material and effectively recover antibody for downstream processing.
Our comprehensive offering for harvest clarification in monoclonal antibody (mAb) development and production processes includes:
- Milliporeยฎ Filters (clarification depth filters & pretreatment solutions, prefilters)
- Milliporeยฎ / SAFCยฎ Buffer and Media Preparation
- Milliporeยฎ Single-Use Systems and Filter Holders
- SAFCยฎ Buffers and CIP Solutions
- Milliporeยฎ Services (single-use and filter validation, equipment installation, system qualification, system training)
- Milliporeยฎ 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
- Clarification Portfolio Guide
Discover Millistak+ยฎ family and Clarisolveยฎ depth filters at a glance.
- Millistak+ยฎ Pod Disposable Depth Filter Performance Guide
The Millistak+ยฎ Pod Disposable Depth Filter Performance Guide is a reference document to provide assistance in evaluating and validating Millistak+ยฎ Pod depth filters for clarification applications.
- How a Bioburden Reduction Filter can Improve Process Efficiency
This report summarizes capacity advantages of Milligardยฎ PES as compared to Millipore Expressยฎ SHC filters following clarification and ultrafiltration and diafiltration (UFDF) steps.
- pDADMAC Flocculation in Monoclonal Antibody Production Processes โ Overcoming Regulatory Challenges with Quality Risk Management
The use of a flocculation agent such as a polycationic polymer polydiallyldimethylammonium chloride (pDADMAC), can improve clarification performance of high density feedstreams.
- Application Note: pDADMAC Flocculant Reagent for Use with Clarisolveยฎ Depth Filters
pDADMAC improves the removal of contaminants by driving the charged flocculation of the negatively charged entities.
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