Search results for " biologics" in Articles / App Notes
Article
Regulatory Challenges in the QbD Paradigm
These products were transferred from the Center for Biologics Evaluation and Research to CDER in 2003 and are rather complex, because they are produced from living organisms that are variable and not …
Article
Pharma Investments Reflect Key Industry Trends
“As a consequence, there is an opportunity to scale down biologics manufacturing, and newer facilities are typically based on 2000-L or smaller reactors and are much less cash-intensive, which is a ke…
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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…
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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
Conventional protocols no longer suitable for traditional biologics
Microbiology testing of pharmaceutical products is performed with a view to detection, enumeration, and identification of 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
…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…
Article
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 …