Search results for "biologic" in Articles / App Notes
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
The goals behind the safe and regulated introduction of biosimilars into the market include increasing access to much-needed biologic medicines and reducing costs (2).
A recent report (3) from …
Article
QbD and PAT in Upstream and Downstream Processing
… Rathore, professor, Indian Institute of Technology (IIT) Delhi; Frederic Girard, CEO, Spinnovation Biologics; Thomas J. Vanden Boom, PhD, vice-president, global biologics research, development and m…
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Continuous Manufacturing: A Changing Processing Paradigm
While only a few approved biologic products in the market—less than 10%, according to estimates by Eric Langer, managing partner, BioPlan Associates—are manufactured through perfusion or continuous do…
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The Bullish Outlook for Biosimilars
Most importantly, a number of patents are set to expire on leading biologics, and financially strapped payers across the globe are anxious to embrace biosimilars and their promise of cost savings. Yet…
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Biopharma Advances Demand Specialized Expertise
Lively, PhD, director of biopharmaceutical services, PPD; Scott Lorimer, VP Global Operations, Patheon Biologics; Eugene McNally, PhD, executive director, PPD Consulting; Rekha Patel, global director,…
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Good Manufacturing Practices: Challenges with Compliance
Cohen (Lubrizol): There are various regulations and guidelines around the world regarding the manufacture of biologics, which include information about control of feedlots and cell lines. These addres…
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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
However, because biological materials—cell substrates and often animal-derived products—are used in their manufacture, viral vaccines and vectors are at risk of contamination from micro-organisms, suc…
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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…