Search results for " surfac"
Poster
Accurate comparability assessment of a biosimilar interferon in process development
This application note describes how to achieve accurate comparability assessments using Biacore™ T200 and
Amersham™ WB system in the development of a biosimilar. This is exemplified in this study…
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
However, when it comes to reverse-phase chromatography or HIC, the mathematical description of hydrophobic interactions between surface and proteins are not optimal today making it difficult to use th…
Article
Trends in Single-use Bioreactors
It is still crucial for the end-user to carefully select the product contact surface (film), hardware, and technology, among other things, that best meet their needs.
Ang (Eppendorf): Many link si…
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Concentration and Diafiltration of Cell-Derived, Live Influenza Virus Using 750 C Hollow Fiber Filter Cartridge
In contrast to normal flow (dead-end) filtration (NFF), the feed is recirculated over a permeable membrane surface (cross flow).This application note describes the performance of GE HealthcareLife Sci…
Article
EMA Invites Comments on New Guidance for Vaccine Development
The guidance provided applies to vaccines for which ample regulatory experience has been gained, as well as to some novel types of vaccines based on established surface antigens.
The most notable …
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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…