Clik here to view.
Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal
Xenotropic murine leukemia virus (XMuLV), one of the model viruses used in this study. WIKIMEDIA COMMONS (HTTPS://COMMONS.WIKIMEDIA.ORG) Most recombinant monoclonal antibodies (MAbs) are produced by...
View ArticleClik here to view.
Advanced Viral Clearance Study Design: A Total Viral Challenge Approach to...
Table 1: Traditional viral clearance (VC) execution (percent virus spiking without large-volume testing) compared with total viral challenge (including large-volume testing) — anticipated VC results...
View ArticleClik here to view.
IgG Purification By Ultrafiltration: Time for Another Look
Figure 1: Fouling of chromatography particle surfaces by compound contaminant associations One of the early disappointments in development of immunoglobulin G (IgG) purification technology was...
View ArticleClik here to view.
Filter-Based Clarification of Viral Vaccines and Vectors
Figure 1: Usual clarification options for viral vaccines and vectors Viral vaccines rely on the antigen properties of a virus or virus-like entity to trigger an immune response and induce immune...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal
Xenotropic murine leukemia virus (XMuLV), one of the model viruses used in this study. WIKIMEDIA COMMONS (HTTPS://COMMONS.WIKIMEDIA.ORG) Most recombinant monoclonal antibodies (MAbs) are produced by...
View ArticleClik here to view.
Advanced Viral Clearance Study Design: A Total Viral Challenge Approach to...
Table 1: Traditional viral clearance (VC) execution (percent virus spiking without large-volume testing) compared with total viral challenge (including large-volume testing) — anticipated VC results...
View ArticleClik here to view.
IgG Purification By Ultrafiltration: Time for Another Look
Figure 1: Fouling of chromatography particle surfaces by compound contaminant associations One of the early disappointments in development of immunoglobulin G (IgG) purification technology was...
View ArticleClik here to view.
Filter-Based Clarification of Viral Vaccines and Vectors
Figure 1: Usual clarification options for viral vaccines and vectors Viral vaccines rely on the antigen properties of a virus or virus-like entity to trigger an immune response and induce immune...
View ArticleClik here to view.
A UF–DF Screening System for Bioprocess Development: Efficient and...
Photo 1: Five-station tangential-flow filtration (TFF) screening system design agreed upon by the collaborators Ultrafiltration and diafiltration (UF–DF) of therapeutic proteins are performed in either...
View ArticleClik here to view.
eBook: Making Filtration Work
Steady improvements in batch-fed cell culture have led to bottlenecks in downstream processing. Filter suppliers are working to improve available tools for purifying therapeutic proteins, to wring...
View ArticleClik here to view.
Making Downstream Processing Continuous and Robust: A Virtual Roundtable
Current biomanufacturing is driven to pursue continuous processing for cost reduction and increased productivity, especially for monoclonal antibody (MAb) production and manufacturing. Although many...
View ArticleClik here to view.
An Integrated Bioprocess for Antibodies: From Harvest to Purified Bulk in Six...
Antibody production platform processes have been widely adopted in biomanufacturing, but many unit operations are not suitable for integration and automation. Here we describe the work of integrating...
View ArticleAddressing Regulatory Requirements for Filter Integrity Testing
Filter integrity is a fundamental element of sterility assurance during production of biopharmaceutical and vaccine products. Integrity test results are a key foundation for drug lot release, so any...
View ArticleViral Nanofilter Integrity: Using Variable-Pathlength UV-Vis Spectroscopy for...
Viral filtration (VF) using nanofilters removes endogenous and/or adventitious viruses from biologic drug-substance manufacturing processes (1). The gold particle test (GPT) is performed as part of...
View ArticleDevelopment of a Single-Use Hermetic Centrifuge System for Mammalian Harvest...
The production of increasingly higher cell densities has stressed the already limited solids-handling capabilities for traditional intermittent ejection centrifuge systems. By contrast, a single-use...
View Article