Search results for " activity"
Article
Witnessing Major Growth in Next-Generation Antibodies
The company is also developing trispecific candidates, including one product that targets two different antigens on the same cancer cell and also modulates the activity of immune cells, recruiting the…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Single-Domain Antibodies for Brain Targeting
Favorable properties, such as good expression, thermal stability, and solubility, are co-selected with binding activity using phage libraries, such as in the case of human VH domain antibodies (21), a…
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Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Article
What is process development?
What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recomb…
Article
Impurity Testing of Biologic Drug Products
They can also be identified as a sub-form of the therapeutic protein, possessing a biological activity either higher or lower than the one of the drug product.”
The second type of impurit…
Article
Quality by design for biotechnology products—part 1
Murine and chimeric antibodies used as human therapeutics frequently produce an immune response that can result in a reduction in or loss of activity and an unfavorable pharmokinetic (PK) profile requ…
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Reviewing the Importance of Biosimilarity and Interchangeability
Among these criteria are comparability, biological activity, impurity assessment, and stability studies, Stamm notes. He explains that, for comparability, the biosimilar needs to demonstrate similarit…
Article
Maximum Output Starts with Optimized Upstream Processing
This activity was certainly serendipitous,” he comments.
Lipinski believes, however, that CDMOs are likely to be more impacted than biopharma companies by upstream capacity issues because they can…