Search results for " system" in Articles / App Notes
Article
Early Communication with Regulators is Essential for SMEs
Understanding the route to drug approval
“From a survey we did in 2011, we found that a lot of SMEs lack personnel with experience of bringing products through the regulatory system. As a result, …
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Implementing QbD in Sterile Manufacturing
They include the process performance as well as the applied systems and the environment, for example, optimized and reduced lyophilization process cycles.
Based on various studies, differing…
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Trends in Downstream Bioprocessing
• Expression systems are producing 5 times what they were 10 years ago.
• Current downstream/purification areas were not designed to handle this increase in production.
• Buffer capacity, colu…
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FDA Seeks Metrics to Define Drug Quality
To move more breakthrough drugs quickly through the approval process, pharmaceutical and biotech companies need to establish high quality production systems early in development. These imperatives put…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013
Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As this new class of biologic medicines is introduced into healthcare systems worldwide, there must be an uncompromising commitment to patient safety, which starts with high regulatory approval standa…
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Essentials in Quality Risk Management
ICH, Q10 Pharmaceutical Quality System (ICH, 2009).
5. ICH, Q11 Development and Manufacture of Drug Substances (ICH, May 2012).
6. FDA, PAT—A Framework for Innovative Pharmaceutical Developmen…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Implementing the infrastructure of a QbD approach to process development involves formalizing the commitment and the strategy and integrating execution into quality systems. The end result is a road m…
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Quality by design for biotechnology products—part 1
Quality by Design (QbD) is a concept applied to the design and development of biopharmaceutical molecules and manufacturing that entails building quality into the process and product in a systematic, …