Search results for " safety"
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Selecting a Comprehensive Bioburden Reduction Plan
This comprehensive approach will lead to greater assurance of patient safety.
Mittelman and Anicetti (PDA task force): There is no single process that will ensure effective bioburden control in a …
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Fluid Handling in Biopharma Facilities
The fluid handling process will be defined by regulatory compliance, economics, safety, sterilization, risk management, process control, automation, productivity, cleanliness, and flexibility. For exa…
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What’s In a Name? For Biosimilars, A Lot
…to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. Our flagship compendia of public standards—United Stat…
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Quality Systems Key to Lifecycle Drug Management
And new policies and procedures at FDA aim to streamline oversight of manufacturing changes for firms that adopt modern production methods able to ensure the continued safety and efficacy of products …
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Use of Multivariate Data Analysis in Bioprocessing
Further, any optimization efforts targeted to improve product yield or productivity need to be carefully monitored for any possible negative impact on a product’s safety and/or efficacy. To achieve th…
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Ensuring the Quality of Biologicals
…lity studies are needed to generate evidence substantiating the similar nature, in terms of quality, safety and efficacy, of the similar biological medicinal product and the chosen reference medicina…
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Modern Manufacturing Systems Key to FDA Quality Initiative
Changes in OPQ’s Office of Biotechnology Products (OBP), for example, aim to enhance its capacity for assessing the quality and safety of a broader range of biotech therapies in development or under r…
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Vaccine Development and Production Challenges Manufacturers
The planned three-arm randomized, double-blinded trial began in early February 2015, and aims to enroll 27,000 healthy volunteers to support this effort to collect clear evidence of safety, efficacy, …
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Tackling Analytical Method Development for ADCs
Testing for safety and quality attributes (bioburden, endotoxin, pH, osmolality, excipients, and appearance) are either verified using compendial-based platform methods or developed per product.
A…
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FDA Approves First Biosimilar
…a, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data—all of which support Zarxio’s use in clinical practice, said Dr. Lou…