Search results for " biologics" in Articles / App Notes
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
Bringing these crucial medicines to market, however, is a challenging process because of the complex nature of biologics. For approximately every 5000 to 10,000 pharmaceutical and biologic discoveries…
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QbD and PAT in Upstream and Downstream Processing
…g 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 …
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Continuous Manufacturing: A Changing Processing Paradigm
GlaxoSmithKline, Johnson & Johnson, Genzyme, Bristol-Myers Squibb, AstraZeneca, Samsung BioLogics, and Novartis AG are among the pharmaceutical companies and contract organizations building or expandi…
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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
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…