Search results for " surfac" in Articles / App Notes
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Novavax’ seasonal and pandemic influenza vaccines consist of VLPs or recombinant particles with matrix proteins that provide a structure onto which the surface proteins hemagglutinin and neuraminidase…
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Trends in BioPharma Approvals in 2013
Like Genentech’s already well-established product Rituxan (rituximab), Gazyva targets the CD20 surface protein associated with B lymphocytes and is approved to treat chronic lymphocytic leukaemia, one…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
These mathematical expressions can be represented graphically as either contour or 3-D response surface plots.
Even this view of the design space is too simplistic. To ensure a process has a…
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Predicting Progress in Protein Aggregation
The properties of the peptide segments of interest generally include the polarity, charge, dipole moment, hydrophilicity and hydrophobicity patterns, accessible surface area, charge, and number and lo…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
From binary to continuum
On the surface, deciding whether an attribute or parameter is critical or not may seem clear and simple. After all, data are compared to acceptance criteria in countless…
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QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Process characterization is often an iterative process involving parameter screening, range identification and response surface mapping. This method enables revisiting the original process development…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
A novel assay for influenza virus quantification using surface plasmon
resonance. Vaccine 28:759–766 (2010)
8. Recommendations for the production and control of influenza vaccine (inactivated)…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
The molecular weight cut-off for the membrane filters was 1 KD and the membrane surface area was 1 ft2. The product step endpoints were as shown in Table I.
An example of the m…
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A Look Ahead at BioPharma Manufacturing and Regulation
Future steps in the research will look into solution conditions that encourage miniaturization of the cells, neutralize cells, or filter surface charges that enhance cell entrapment on filter membrane…