Search results for " safety"
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Getting your investigational drug regulatory ready
From the submission of an investigational new drug (IND) application, regulators will want to see a purposeful plan to assess drug safety, quality, and efficacy over time. In this article, we outline …
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Developing a Robust Bioprocess Using Mechanistic Models
The safety and efficacy of a biopharmaceutical drug are of the highest priority. Therefore, manufacturers have to design, implement and maintain measures to ensure that the bioprocess con…
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Analysis of mRNA Therapeutics and Vaccines
Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.
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In silico Approaches towards Automated Biomanufacturing
The goal of manufacturing is to control and maintain a commercial process capable of consistently producing a drug of the highest quality and safety. As part of manufacturing science and t…
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Novavax Reports on Two Vaccine Efficacy Studies
A large study of the NVX-CoV2373 vaccine enrolled nearly 30,000 participants in the United States and Mexico to evaluate efficacy, safety, and immunogenicity. The results showed an overall efficacy of…
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EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
The paper will address options for introducing a new strain into an existing approved vaccine; the minimal regulatory requirements for quality, safety, and efficacy; and bridging studies required to p…
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Process Development: 2020 Reflections and 2021 Possibilities
Among the many vaccine challenges in relation to the urgency provoked by COVID-19 are safety and the ability to scale up the manufacturing process. Scaling up viral vector and virus manufacturing proc…
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Virus-like Particles as Therapeutic Moieties of the Future
Several VLPs can be easily produced at a large scale (4) and have a better safety profile due to the lack of viral genome. Further, owing to their highly repetitive surface structure and resemblance t…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
With the changing industry tide favoring multiproduct manufacturing facilities, methods to enhance efficiency without sacrificing quality or safety are needed,” he says.
Several activities must be…
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Can Vaccine Development Be Safely Accelerated?
Inovio began animal testing of INO-4800, its COVID-19 vaccine candidate, in February 2020 and is aiming to begin human safety testing in early summer 2020. The company will conduct tests in both the U…