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.
Virus Inactivation
Many well-characterized cell lines commonly used for mAb production contain endogenous retrovirus-like particles that are constitutively expressed and transmitted through sequential cell passage. Viral inactivation treatments, using low pH or detergents, are typically performed during downstream mAb purification to reduce the levels of infectious enveloped viruses and help ensure patient safety.
Inactivation relies on high-quality raw materials to minimize the risk of microbial contamination and meet Pharmacopoeia requirements. Performing the necessary raw material qualification tests and compiling the required documentation can be costly and time-consuming.
Our full suite of virus inactivation products, services, and expertise include:
- Bioreliance® Viral Clearance Testing
- Millipore® Single-Use Solutions (mixing, 2D/3D assemblies and storage)
- Millipore® Buffer Filters
- Millipore® Equipment and Systems (mixer)
- Millipore® Sampling Solution (offline system)
- SAFC® Pharma Raw Materials (solvent/detergents, reagents, liquid CCM & 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
- Article: Viral Safety in Bioprocessing
This article discusses viral safety strategies and invites you to download our Viral Safety eHandbook for more detailed information on all aspects of viral safety in mAb processing.
- Flyer: Emprove® Detergents for a Sustainable Triton™ X-100 Replacement in Biologics Manufacturing
Comparison of Deviron® C16 Emprove® Evolve detergent and the Deviron® 13-S9 Emprove® Expert detergent, with Triton™ X-100 Emprove® Expert Detergent.
- Brochure: Greener Alternatives to Triton™ X-100 for Biopharmaceutical Applications
Viral inactivation with Deviron® Detergents, cell lysis with Deviron® Detergent, detection and process removal of Deviron® Detergent.
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