Search results for " quality" in Articles / App Notes
Article
USP Stresses Pharmacopeial Standards at CPhI China
The seminar was designed to explain the latest quality standards and regulatory updates to the more than 120 participants. Topics included global harmonization with industry standards and regulations,…
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Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
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Re-use of Protein A Resin: Fouling and Economics
Typical parameters that are used for column monitoring include yield, height equivalent to theoretical plate (HETP), impurities in eluate, product quality, and chromatographic profile (19–21). More re…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Immunogenicity and efficacy
High levels of aggregates can reduce therapeutic efficacy of a biologic, or impair product quality or stability. This could increase the risk of an immunogenic response…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Third is increased focus on relating the quality attributes of a biotech product to its clinical safety and efficacy. Fourth is the extension of the QbD concepts from the traditional process developme…
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Relationship Building at Top of Mind for Clients
…mall scale and large scale when a CMO has been engaged, and clients will always demand expertise and quality.
But the trends in the data suggest that as the CMO market becomes more competitive and…
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EMA Invites Comments on New Guidance for Vaccine Development
It follows the publication of a module on the quality requirements.
The new modular guideline is intended to cover and update in one single, consolidated document the existing guidance on regulato…
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Outsourcing Trends in Biopharmaceutical Manufacturing
Process development was the only area where over half of respondents plan to offshore in the next five years (although with increased emphasis on QbD and related quality issues, one would presume less…
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Navigating Emerging Markets: Middle East and North Africa
As the standard of living in the region generally improves, healthcare providers will face rising expectations for more and better quality services. These expectations, together with population growth…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
That topic was discussed more in detail by Christophe Segard and Catherine de Coupade from LFB in the Manufacturing and Quality sessions.
On the topic of Pathogen Safety, Sally Bayliss from Paul…