Search results for "biologic"
Article
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…
Article
Prescribing Caution for Biosimilars
These legislative efforts represent a significant step in recognizing the important and complex role biologic medicines play in the future of healthcare and chronic disease management. They are also a…
Article
Regulatory Challenges in the QbD Paradigm
This model is especially evident in FDA's Center for Drug Evaluation and Research (CDER) as used for therapeutic biological products, such as proteins and monoclonal antibodies. These products were tr…
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Pharma Investments Reflect Key Industry Trends
First is the shift to biologic-based drugs, which has occurred along with a dramatic increase in the productivity, mainly in terms of much higher titers, of biopharmaceutical processes. “While demand …
Article
Elucidating Biosimilars Characterization
The growth corresponds to a 20% increase from last year’s figures and accounts for approximately 2% of the overall biologics market. Although narrowly focused on only a small number of therapy areas a…
Article
Reimagining Affordable Biosimilars
With an anticipated valuation of over $200 billion by 2022, this popularity of protein-based biologics can be attributed to their unique target specificity in protein–protein interactions for the trea…
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Microbiological Testing: Time is of the Essence
Challener
Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbi…
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Preclinical Evaluation of Product Related Impurities and Variants
Not all biologics can be subjected to a uniform panel of tests owing to their differences in their modes of action as well as their inherent biological/chemical complexities (8). In this 38th article …
Article
Managing Residual Impurities During Downstream Processing
Challener
Manufacture of protein and other biologic drug substances via cell culture or fermentation occurs with the natural, simultaneous production of other unwanted materials, particularly host-…
Article
Unifying Continuous Biomanufacturing Operations
The most efficient upstream processing systems in biologics manufacturing seek to mimic the body’s treatment of cells, so a constant level of incoming nutrients and outgoing waste products is necessar…