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Chromatography

How to Remove Trace Impurities in Chromatography Analytics

| Author / Editor: RAMESH MUNDLAMURI, SUDHA JAYAN / Dominik Stephan

Quality Control of Virus Filters: Biopharmaceutical companies check the filterability of their product, such as monoclonal antibodies, initially by performing lab-scale test series. In these series, they filter their product using different membrane types and check the flow rates, total throughput and binding capacity to determine the optimal membrane and filter area for their product and particular process step. During in-house quality control, the virus-retentive membrane is also routinely tested for its capacity to retain viruses.
Quality Control of Virus Filters: Biopharmaceutical companies check the filterability of their product, such as monoclonal antibodies, initially by performing lab-scale test series. In these series, they filter their product using different membrane types and check the flow rates, total throughput and binding capacity to determine the optimal membrane and filter area for their product and particular process step. During in-house quality control, the virus-retentive membrane is also routinely tested for its capacity to retain viruses. (Picture: Sartorius)

Wether tracking proteins, DNA or endotoxins, adsorber capsules play an important role in all kinds of chromatography analytics. Yet, impurities can affect the precision of the measurement significantly. Now, a new dsevelopment effectively removes various impurities from protein feedstocks and are available in lab and process scale.

Sartobind Q Membrane Adsorber capsules represent an already well established generation of ion exchange chromatography devices based on macroporous membranes. Sartobind Q capsules are disposable and help in effectively removing the trace impurities including host cell protein (HCP), DNA, endotoxins and viruses from monoclonal antibody or other protein feedstocks during polishing step. These single-use devices significantly reduce validation requirements, capital equipment expenditures, time and labor when compared to traditional column based anion exchange resins.

Sartobind IEX SingleSep Pico, Nano and Mini have been developed for working with small sample volumes and they are perfect for small scale applications, screening purposes and laboratory scale flow-through purifications.

Sartobind IEX SingleSep 5“, 10“, 20“, 30“ and mega have been developed for intermediate and pilot scale up to production scale in the biopharmaceutical industry. Here we have provided the data regarding physico and chemical characteristics, technical performance of Membrane Adsorbers and scalability studies. Characteristics of Membrane Adsorbers with 4 mm bed height Membrane Adsorber features:

  • ●●Ready-to-use
  • ●●Easy and simple handling (like a filter)
  • ●●Pore size > 3 μm allowing high flow rates
  • ●●Low bed height (4 mm)
  • ●●Negligible diffusion limitation
  • ●●No bed cracking, channeling, air entrapment
  • ●●Scalable to production volumes
  • ●●Robust high performance separations
  • ●●High dynamic binding capacity
  • at high flow rates
  • ●●Recommended flow rates of ion exchange
  • membranes are 10-30 bed volumes per minute
  • ●●Units can be utilized e.g. by peristaltic
  • pumps or liquid chromatography systems
  • ●●Cost reduction during purification of valuable
  • proteins and viruses by smallest bed size

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