Search results for " vaccine"
Article
Process Chromatography Selection for Downstream Processing Applications
…f one excludes mAbs, then the molecules of interest are generally peptides, recombinant proteins, or vaccines. For these molecules, chromatographic techniques such as ion-exchange, hydrophobic intera…
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Generating a Fully Processed Antibody
These include molecules such as virus-like particle (VLP) vaccines, proteins that require cleavage, or other additional post-translational modifications not typically performed by Chinese hamster ovar…
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Affinity chromatography Handbook - Vol. 3: Specific Groups of Biomolecules
Affinity chromatography (AC) separates proteins on the basis of a reversible interaction between a protein (or group of proteins) and a specific ligand coupled to a chromatography matrix. The techni…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
By Mark Plavsic
Use of continuous cell lines in the manufacture of biological therapeutic products, such as vaccines, recombinant proteins, and monoclonal antibodies, is associated with the concom…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Will the facility be manufacturing monoclonal antibodies, recombinant proteins, vaccines, antibody-drug conjugates, or fragment antibodies? Also, will the products be mammalian cell-derived or microbi…
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Innovative Therapies Require Modern Manufacturing Systems
FDA’s Center for Biologics Evaluation and Research (CBER) also approved more than a dozen new biologics, vaccines, blood products, and diagnostics.
In the process, FDA met nearly all the review ti…
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Framing Biopharma Success in 2016
The Center for Biologics Evaluation and Research (CBER) approved more than a dozen new biologics, vaccines, blood products, and diagnostics. These numbers, and types of drugs approved, indicate that t…
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mAbs to Watch in 2016
Ibalizumab—The medication ibalizumab is believed to be a promising treatment for HIV, as it represents a treatment alternative to traditional antiretroviral therapies (ARTs) and HIV vaccines. It repre…
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USP Publishes Monoclonal Antibody Guidelines
Because biologic medicines range from simple structures like certain peptides to complex mixtures, such as vaccines, establishing meaningful quality attributes for each specific product can present ch…
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Technologies and Practices Must Evolve to Meet Demand
A majority of survey respondents work for organizations that develop and manufacture large-molecule drugs, both small- and large-molecule therapies, and vaccines; more than 18% indicated that their or…