Search results for " bacteria"
Poster
Collaborating to address the bioburden challenge
Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batche…
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Real Time Continuous Microbiological Monitoring
…e detection cell, resulting in the real-time detection of both inert particles and biologics such as bacteria, yeasts, and molds. Fluorescent (or fluorophore) dyes (molecules) can absorb light at one…
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Implications of Cell Culture Conditions on Protein Glycosylation
Certain bacteria can be used for production of the simplest proteins, those that are composed only of amino-acid polymers, with no post-translational modifications (PTMs) such as glycosylation, becaus…
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Aseptic Processing: Keeping it Safe
Filters, in particular, should be analyzed for removal of bacteria (such as challenge organism Brevundimonas diminuta) from the stream per ASTM 838-05, and investigators should be able to demonstrate …
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Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
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Elucidating Biosimilars Characterization
Biological molecules are also manufactured by processes involving living organisms, such as genetically engineered bacteria, yeast, or mammalian cells, and although these processes can be well-defined…
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A Look Ahead at BioPharma Manufacturing and Regulation
Among these species are common water bacteria that CDC [Centers for Disease Control and Prevention] have shown to be difficult to detect using compendial methods. In collaboration with CDC and with he…