Search results for " safety" in Articles / App Notes
Article
Going Small to Achieve Success on the Commercial Scale
Unlike initial processes that are used during the discovery and early development phases to produce material for characterization, efficacy, safety, and other studies, scale-down models are intended t…
Article
Tools for Continuous Bioprocessing Development
These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.
The ability to codify…
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Biopharma in 2015: A Year for Approvals and Innovations
Biosimilars have an exemplary safety track record in the EU, Japan, and Canada. The EU was the first geographic market to develop the process of authorization of biosimilars, setting an example for ma…
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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 …
Article
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…