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mAbs Downstream

Products for Development and Manufacturing

HomeIntegrated OfferingsMonoclonal Antibodies (mAbs)Process Development and ManufacturingDownstream ProcessingVirus Inactivation

 

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. 

Downstream Processing
Clarification
Prefiltration & Bioburden Control
Affinity Chromatography
Virus Inactivation
Polishing Chromatography
Virus Filtration
Concentration and Diafiltration

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 Products
Product NumberProduct NameProduct DescriptionPricing
A6964Accutase® solutionsterile-filtered, suitable for cell culture
C-29912Freezing Medium Cryo-SFMSerum-free medium for cryopreservation, 125 ml
C-29910Freezing Medium Cryo-SFMSerum-free medium for cryopreservation, 30 ml
C-14090Human Mesenchymal Stem Cells (hMSC)Derived from bone marrow, 1 million cells per pellet
C-14091Human Mesenchymal Stem Cells (hMSC)Derived from umbilical cord matrix, 1 million cells per pellet
C-14092Human Mesenchymal Stem Cells (hMSC)Derived from adipose tissue, 1 million cells per pellet
C-28016Mesenchymal Stem Cell Adipogenic Differentiation Medium 2Ready-to-use kit including Basal Medium and SupplementMix, 100 ml
C-28012Mesenchymal Stem Cell Chondrogenic Differentiation MediumReady-to use kit including Basal Medium and SupplementMix (with Inducers), 100 ml
C-28014Mesenchymal Stem Cell Chondrogenic Differentiation MediumReady-to use kit including Basal Medium and SupplementMix (without Inducers), 100 ml
C-28009Mesenchymal Stem Cell Growth Medium 2Ready-to-use kit including Basal Medium and SupplementMix, 500 ml
C-28019Mesenchymal Stem Cell Growth Medium DXFReady-to-use kit including Basal Medium and SupplementMix, 500 ml
C-28015Mesenchymal Stem Cell Neurogenic Differentiation MediumReady-to-use kit including Basal Medium and SupplementMix, 100 ml
C-28013Mesenchymal Stem Cell Osteogenic Differentiation MediumReady-to-use kit including Basal Medium and SupplementMix, 100 ml

Related Categories

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Buffers & pH Adjusters

Our broad portfolio of buffer materials manufactured under appropriate controls is tailored to your needs.

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An industrial clarification filter system featuring multiple cylindrical units mounted on a metal frame, complete with gauges and valves, designed for large-scale filtration processes.
Clarification & Harvest

Clarification steps prepare your bioreactor harvest material for downstream purification by reducing the levels of impurities and particulates.

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Chromatograph system for bioprocessing, featuring various tubes, dials, and components, predominantly silver with blue accents and a logo featuring the letter ‘M’ on the side panel.
Chromatography

Downstream purification in bioprocessing includes one or more chromatographic separation steps to purify your molecule and remove impurities.

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Sterile Filtration and Bioburden Control

Our broad portfolio of membrane filters offers options for efficient processing of every pharma and biopharma stream.

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Viral Clearance

Our viral clearance portfolio includes the virus filtration solutions, chemicals, holders and systems.

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Mobius® FlexReady Solution for TFF
Ultrafiltration & Diafiltration

Ultrafiltration & diafiltration increase capacity, concentration, and recovery in bioprocessing.

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