Search results for " approval" in Articles / App Notes
Article
Genetic Vaccine Platforms Demonstrate Their Potential
This situation has started to change with FDA granting Emergency Use Authorizations to the mRNA vaccines from Pfizer-BioNTech and Moderna for COVID-19 in late 2020 and approval for the viral-vector va…
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Virus-like Particles as Therapeutic Moieties of the Future
A VLP-based vaccine for malaria, Mosquirix (RTS/S), has received approval from regulatory authorities. This is the first vaccine for malaria in the world (9).
Attempts have been taken to widen …
Article
The Importance of Partnering for Bioanalytical Studies
Bioanalytical work serves to supplement pivotal studies and aid in the decision-making process for approval, safety, and/or labeling of a drug or biologic; in short, without proper bioanalytical data,…
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New Therapies Present Scaling Challenges
By Feliza Mirasol
The approval of emerging biologic-based therapeutics—such as cell and gene therapies—presents challenges and decisions for drug companies looking to increase the manu…
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Biosimilar Quality Requirements
By Feliza Mirasol
Recent guidelines released by FDA emphasize the agency’s efforts to ease the path toward regulatory approval for biosimilars and marks significant action taken by the agency to h…
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Biosimilars undergo limited clinical examination prior to approval under the premise that comparability to the corresponding innovator product using an exhaustive analytical characterization exercise …
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A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Article
CDMOs Driving Emerging Bio/Pharma Success
…l therapies
• A favorable regulatory environment that offers faster routes to new drug approval
• A robust equity investment environment across the economy
• Aggressive partnerin…
Article
Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …