Search results for " comparability" in Articles / App Notes

Article Challenges in Analytical Method Development and Validation
Besides providing sufficient qualification or validation results for the new method, method comparability results should also be provided. In some cases, product specifications may need to be re-evalu…

Article Trends in BioPharma Approvals in 2013
In 2013,  20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…

Article Outsourcing Trends in Biopharmaceutical Manufacturing
The author highlights the top 10 outsourcing trends revealed during a survey of biopharmaceutical manufacturers. The biopharmaceutical industry is changing the way it manufactures. According to …

Article EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe. Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a…

Article Determining Criticality, Part Two: DoE and Data-Driven Criticality
Establishing similar run conditions at multiple scales is an important consideration when trying to qualify the comparability between full-scale and small-scale experiments. Substantial prior experien…

Article 2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement. In a recent survey of current trends and practices in biopharmaceutical manufacturing…

Article FDA Seeks Metrics to Define Drug Quality
…n policies; and reduce preapproval requirements for site transfers, assay improvements, and extended comparability protocols particularly for “good actors” in GMP compliance. From the agency’s pe…

Article Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East. The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…

Article The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…

Article Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.  ABSTRACT The use of small-interf…

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