Search results for "antibody"
Article
Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies.
Sep 1, 2014
By: Jane Wan
BioPharm International
Volume 27, Issue 9, pp. 8-12
On March 25, 2014, the…
Article
Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.
Aug 2, 2014
By: Cynthia Challener, PhD
Pharmaceutical Technology
Volume 37, Iss…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
Thus, even at low levels, their presence can lead to antibody production against the drug, resulting in more rapid clearance and lower efficacy, and at higher levels, anaphylaxis,” he explains.
In…
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2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
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Drugs, At What Cost?
Generics, market dynamics, and global demand are changing drug spending patterns.
The underlying question for any drug in development is: What price can (or will) patients pay for the needed…
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Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…
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Trends in Downstream Bioprocessing
At present, most industry decision-makers find current Protein A, particularly, in the US and EU (versus the rest of the world), to be an adequate, if expensive, solution for antibody capture. Alterna…
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Stirring up the fermentation game
fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.
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Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“One expects that there will be minor differences in, for example, glycosylation patterns or the extent of deamination in a monoclonal antibody product. One expects that there will be slight differenc…