Search results for " safety" in Articles / App Notes
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Other raw materials used in the manufacture of biotherapeutics, especially those of animal and human origin, could also present a viral safety risk.
Traditionally, the management of inadvertent vi…
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Application of Quality by Design to Viral Safety
The viral safety of a product is an important CQA, and the following is an overview of how QbD can be applied to both the selection and testing of raw materials for adventitious viruses as well as the…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Since then, better safety measures and the use of established and characterized cell lines have improved safety in biologicals. To date, no infectious virus has been transmitted to a patient by a cell…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Although the same concerns for safety are ultimately expected to drive other cell-culture bioprocesses toward this goal, several challenges still remain, including for some of the most promising new o…
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Virus safety challenges: get the job done!
Virus safety is key in bioprocessing. In this free 1-day seminar you’ll learn how to conduct virus filterability trials, including prefiltration.
Click here for more information
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Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
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Reimagining Affordable Biosimilars
Other challenges for biosimilars are frequent failures in demonstration of biosimilarity and establishment of clinical equivalence for efficacy, immunogenicity, and safety (5). There is a growing need…
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Quality by design for biotechnology products—part 1
Next, CQAs of the product are identified, based on the understanding of the impact of various quality attributes on the safety and efficacy of the product. The initial assessment is based on molecular…
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Preclinical Evaluation of Product Related Impurities and Variants
Despite their success, the adoption of biotherapeutics is marred by issues around affordability as well as risks associated to the challenges in assessment of their safety and efficacy arising from th…