Search results for " biologics"
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Managing Residual Impurities During Downstream Processing
…that assures access to high quality medicines,” according to Fouad Atouf, vice-president of global biologics with the United States Pharmacopeial Convention (USP). “They are intended,” he adds, “to s…
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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…
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Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
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The Importance of Partnering for Bioanalytical Studies
…CROs), about the need for bioanalytical testing programs and regulatory strategies for potential new biologics.
Importance of bioanalytical studies
BioPharm: Why is it so important to conduct …
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical industry by attacking disease using the mechanisms of the cell and immune system. These therapies are fragile…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes changed dramatically once it was discovered in 1996 that a fatal disease (variant Creut…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Notably, the latter changes, which will take effect in early 2016, include expectations for authentication of key biological and/or chemical resources, such as cell lines, antibodies, and other biolog…
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Setting Standards for Biotech Therapeutics in India
With the ongoing shift from small molecules to biologics, the Indian biopharmaceutical industry is also set to replicate the success received by the Indian pharmaceutical companies (Figure 1B) (1). Th…
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Enhancing Resins Addresses Purification Concerns
There are, however, similarities in certain classes of biologics, such as monoclonal antibodies. “Because traditional monoclonal immunoglobulin G (IgG) products share a similar structural and chemical…
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An Analytical Approach to Biosimilar Drug Development
That is due to the natural variability and inherent complexity in manufacturing of biologics for which the demonstration of identical quality attributes (pharmaceutical equivalence) as required by the…