Search results for " monoclonal"
Article
Continued Process Verification for Biopharma Manufacturing
Its recommendations are based on a typical cell culture production process for making a fictitious monoclonal antibody (mAb) product (3). Although this model plan does not provide examples of all aspe…
Article
Application of Quality by Design to Viral Safety
In two recent papers, Genentech (a member of the Roche group) reported on work it has conducted on developing viral clearance process design spaces for two unit operations commonly used in monoclonal …
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
Single-Domain Antibodies for Brain Targeting
Going single domain
Biologic therapies such as monoclonal antibodies (mAbs) are enabling the targeted, personalized treatment of cancer, inflammatory diseases, infectious diseases, and diseases of…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Three recombinant Chinese hamster ovary (CHO) cell lines, developed in-house to produce three different monoclonal antibodies, were used in this study. Cell lines A and B are dihydrofolate reductase-d…
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Q&As with Industry Leaders
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Jeanne Linke Northrop, BioPharm International
Jakob Liderfelt, Global Product Manager, Monoclonal Antibody Polishing, Cytiva
Top challenges in recombinant protein purification…
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Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
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2014 Manufacturing Trends and Outlook
…oduct
Almost 45% of the respondents reported that their organizations manufacture therapeutic monoclonal antibodies (mAbs); more than 55% of those surveyed said they manufacture protein-based …
Article
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
Moreover, the 5- to 10-fold improvement in product titers for monoclonal antibodies over the past 15 years has nearly eliminated arguments against single-use based on scale. Bioprocessors can now gene…