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Virus Risk Mitigation for Raw Materials
Recombinant protein–based medicinal products and modern cell-based vaccines have a very strong safety history with respect to viral and microbial contamination. However, virus contamination incidents...
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Effects of Pressure Sensor Calibration Offset on Filter Integrity Test Values
Food and Drug Administration (FDA) and European good manufacturing practices (GMPs) require integrity testing of sterilizing-grade filters for producing injectables and other biologics. The diffusion...
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Accounting for the Donnan Effect in Diafiltration Optimization for...
The biopharmaceutical industry is targeting high-concentration protein formulations to enable subcutaneous administrations. Such administration can provide better patient convenience than intravenous...
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Nucleic Acid Impurity Reduction in Viral Vaccine Manufacturing
Commercial-scale viral vaccine manufacturing requires production of large quantities of virus as an antigenic source. To deliver those quantities, a number of systems are used for viral replication...
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Diatomaceous Earth Filtration: Innovative Single-Use Concepts for...
Figure 1: Filtration principle of dynamic body-feed filtration (DBF) with diatomaceous earth (DE) (left) and conventional filtration (right) In the past decade, biopharmaceutical manufacturers have...
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Preuse, Poststerilization Filter Integrity Testing for Single-Use and...
http://www.bioprocessintl.com/wp-content/uploads/2014/10/102014_Stering.mp3 According to current European Union good manufacturing practice (EU GMP), integrity testing of sterilizing-grade product...
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Evolving Clarification Strategies to Meet New Challenges
Increasingly efficient bioreactors allow biopharmaceutical manufacturers to achieve higher cell densities. That improved upstream efficiency has led to new purification challenges resulting from high...
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Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal
To date, the majority of recombinant monoclonal antibodies (MAbs) have been produced by mammalian cells. During such production processes, the potential risk of entrained viruses must be critically...
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Characterization of Postcapture Impurity Removal Across an Adsorptive Depth...
EMD MILLIPORE (WWW.EMDMILLIPORE.COM) In the manufacture of monoclonal antibodies (MAbs), the first purification step following harvest clarification is normally protein A affinity chromatography...
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Factors Affecting Sterile Filtration of Sodium-Carboxymethylcellulose–Based...
Figure 1: Idealized possible unit structure of sodium carboxymethylcellulose (CMC) with a DS of 1.0; the DS would be 3.0 if all three hydroxyl groups on anhydroglucose unit were substituted. A DS of...
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Virus-Filtration Process Development Optimization: The Key to a More...
Figure 4: Description of Viresolve Prefilter (left) and Viresolve Pro Shield (right) adsorptive prefilters Size-exclusion–based parvovirus filtration is an important step toward drug product safety in...
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Best Practices for Critical Sterile Filter Operation: A Case Study
Figure 1: Design and layout of Millidisk and Millipak barrier filters A number of regulatory guidelines recommend preuse integrity testing of critical sterilizing liquid filters for aseptic processing...
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Membrane-Based Clarification of Polysaccharide Vaccines
Figure 1: General polysaccharide conjugate vaccine process (UF/DF = ultrafiltration/diafiltration) Polysaccharide vaccines are essential for protection against infectious diseases, which remain an...
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Membrane Adsorbers, Columns: Single-Use Alternatives to Resin Chromatography
Figure 1: Right-sizing and rapid multicycling enables small-footprint downstream processing to match high-productivity upstream production (adapted from reference 1). Filtration membranes are used...
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Single-Use Depth Filters: Application in Clarifying Industrial Cell Cultures
Depth filtration at Rentschler (WWW.RENTSCHLER.DE) For current process development phases, many biomanufacturers’ attention is directed increasingly to the first unit operation in downstream...
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Downstream Disposables: The Latest Single-Use Solutions for Downstream...
Single-step harvesting of a high-density cell culture from a Biostat STR bioreactor with Sartoclear Dynamics body-feed filtration from Sartorius Stedim Biotech (WWW.SARTORIUS.COM) Downstream processing...
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Examining Single-Use Harvest Clarification Options: A Case Study Comparing...
Figure 1: Harvest clarification options Steadily increasing demand for biopharmaceutical drugs has led the industry to examine its manufacturing scales while pressuring research and development groups...
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Scaling Considerations to Maximize the High-Area Advantage
Figure 1: Conventional and M-pleat pattern Maximizing filtration-area density is a design strategy to minimize filter footprint and improve filtration process economics. Pleated membrane formats...
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New Dimensions in Single-Use Filtration
The ready-to-use MaxiCaps MR system is entirely disposable and enables the integration of three, six, or nine 30-inch filter capsules. Whether viral vectors are clarified or the bioburden after cell...
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eBook: Development of a Representative Scale-Down UF/DF Model: Overcoming...
Scale-down models (SDM) are physical, small-scale models of commercial-scale unit operations or processes that are used throughout the biopharmaceutical industry for validation studies, commercial...
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