Search results for " biologics"
Article
Maximum Output Starts with Optimized Upstream Processing
Significant growth in the development and manufacturing of biologics—from traditional recombinant proteins and monoclonal antibodies (mAbs) to advanced multispecifics, antibody-drug conjugates, viral …
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Ensuring Viral Safety of Viral Vaccines and Vectors
In 2014, using next-generation sequencing (NGS), FDA’s Center for Biologics Evaluation and Research (CBER) retrovirus laboratory identified a novel rhabdovirus in Spodoptera frugiperda type 9 (Sf9) ce…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
FDA, Memorandum: Points to Consider in Characterization of Cell Lines Used to Produce Biologics (Rockville, MD, Jul. 12, 1993).
11. FDA, Memorandum: Points to Consider in the Manufactu…
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Prescribing Caution for Biosimilars
They are also a necessary measure to ensure that patients and their physicians remain in control of their medical treatment decision-making as the market for complex biologics evolves over the next se…
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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 …
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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 …