Search results for " approval"
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
What are some challenges in bringing new manufacturing technologies to commercial operations?
Developing a process to produce a biologic-based drug—and gaining regulatory approval for that process…
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Biosimilars to Drive Modern Manufacturing Approaches
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch additional programs to develop competitive biotech therapies, regulatory authorities and in…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Manufacturing changes may be frequent and approval times for changed products can be lengthy (17).
In this article, the use of SPR in the characterization of bispecific antibodies--including under…
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Continuous Manufacturing: A Changing Processing Paradigm
…re to establish and validate its manufacturing process could negatively affect its ability to obtain approval for or launch of lumacaftor in combination with ivacaftor. “While we believe continuous p…
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Essentials in Establishing and Using Design Space
Design space is proposed by the applicant and is subject to regulatory assessment and approval. Movement within the characterized design space is not considered as a change and, therefore, allows for …
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Biosimilars Development and Supply: How Complex Can the Process Be?
As this new class of biologic medicines is introduced into healthcare systems worldwide, there must be an uncompromising commitment to patient safety, which starts with high regulatory approval standa…
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Novavax Reports on Two Vaccine Efficacy Studies
Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.
Novavax announced on June 14, 2021, results from two studies of is recombinant…
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Getting Your Investigational Drug Regulatory Ready
This article outlines basic strategies for efficient regulatory review and drug approval.
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Best Practices for Selecting a Top-Quality Cell Line
“Whichever method is used for clonal selection should be well validated and ideally utilized in programs that have gained regulatory approval,” he states.
The sharp increase in the complexity o…
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Tools and Processes for Mature and Emerging Therapies
Budget constraints, uncertainty about unproven technology, and concerns about gaining regulatory approval were some reasons biopharma companies hesitate to adopt new technologies.
Emerging therapi…