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.
Prefiltration & Bioburden Control
Particulate and bioburden contaminants can cause premature fouling of aseptic filters and interfere with downstream purification. Prefilters remove particulate impurities such as colloids, aggregated and non-product proteins, lipids, and cellular debris. They also provide a cost-effective option for improving process efficiency by extending the capacity of costly sterilizing filters and reducing the impact of particulate contaminants in chromatographic separation.
Bioburden reduction filters remove particulate impurities and different types of bioburden. Downstream operations operate as “low bioburden” or “bioburden-controlled,” where bioburden is present but controlled and routinely monitored. Bioburden control strategies include assessing bioburden, mitigating the risk of occurrence, and monitoring to assure process control.
Our integrated offering of prefilters and bioburden reduction filters includes:
- Millipore® Filters
- Millipore® Integrity Testers
- Millipore® Equipment and Systems (housings)
- Millipore® Sterile Sampling
- 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
- Brochure: Mission: Control - Strategies for Effective Bioburden and Aseptic Control
In this series of articles, we provide information to highlight the differing objectives for bioburden control by unit operation and discuss the parameters that guide filter selection and optimization.
- How Membrane Prefilters Enhance Bioprocessing Efficiency
Milligard® PES filters improve sterilizing-grade filter capacity and process economics.
- Bioburden Reduction and Particulate Retention Using Milligard® PES Filters
Learn how Milligard® PES filters can be used as standalone filters in less critical process steps to remove particulates, reduce bioburden and provide high throughput.
- Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
Filter integrity testing doesn’t always go smoothly. Learn how to avoid costly mistakes and troubleshoot integrity test challenges.
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