Search results for " safety"
Article
Quality by Design and Extractable and Leachable Testing
Feb 01, 2015
By Anthony Grilli
BioPharm International
Biopharmaceutical packaging performs several vital functions in assuring the drug product safety. First and foremost, packaging must b…
Article
Securing the Single-Use Supply Chain
Different views of dual sourcing
The ultimate goal of multisourcing is to have the ability to seamlessly transfer from one single-use product source to another without risk to patient safety, acco…
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Biopharma Manufacturers Respond to Ebola Crisis
Accelerating vaccines
The WHO consultation identified two vaccines with sufficient data on immune response in primates and fast production potential to warrant initial safety testing in humans. Gl…
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Using Quality by Design to Develop Robust Chromatographic Methods
The ATP criteria, as with ICH method validation criteria, are established based on considerations for patient safety and product quality and are consistent with the capability of analytical methodolog…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
…mAbs, including information on pharmaco-toxicologic, pharmacokinetic, pharmacodynamic, efficacy, and safety studies. In 2013, the agency also issued a draft concept paper on the comparison of biosimi…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The safety margin of 0.5 °C is applied to narrow the CPP limit from the design space. Therefore, if the design space is 25.0 °C to 35.0 °C, the NOR becomes 25.5 °C to 34.5 °C. Additional factors, such…
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EMA Collaborates with HTA Assessment Networks
First a drug has to be approved for its quality, safety, and efficacy by one or more regulatory authorities. This approval can be either by the central London-based European Medicines Agency (EMA) for…
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FDA Seeks Metrics to Define Drug Quality
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern about drug quality and safety. Despite a decade of encouragement and guidance from FDA, manuf…
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Report from the 12th Plasma Product Biotechnology Forum
…o negative effects from the alterations to centers needed to accommodate social distancing and other safety measures. Even after the availability of new vaccines and relaxed restrictions, the plasma …
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Pandemic Alters Policies and Practices for Drug Development and Regulation
At the same time, the regulators required vaccine trials to test thousands of patients to assure the public of the safety and viability of these new preventives. Vaccine experts at the Center for Biol…