Search results for " guidance" in Articles / App Notes
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
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Manufacturers Struggle with Breakthrough Drug Development
FDA briefly outlined the basic components of manufacturing development programs needed for approval of breakthroughs in a June 2013 guidance (1). To ensure availability of a quality product at time of…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
FDA's 2007 draft guidance for industry defines TPP as a format for a summary of a drug development program described in terms of labeling concept (1). QTPP is defined in ICH Q8 (R2) as "a prospective …
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Free handbook for column packing and maintenance
Impossible to get right? This new handbook can help! Packed with valuable guidance for using AxiChrom™, BPG and Chromaflow™ columns, you’ll discover ways to pack every column quickly and consistently.…
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Chromatography for the Diversified Antibody Pipeline
Furthermore, we have experienced that FDA has published their guidance for development of this new class of antibodies. I believe everyone is expecting that they will increase in the future.
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Report from the 12th Plasma Product Biotechnology Forum
Dorothy Scott, FDA’s Branch Chief of the Plasma Derivatives Branch, discussed the challenges on plasma supply and during the Covid-19 pandemic, which forced new regulatory guidance to be applied. One …
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Understanding Protein Production from Start to Finish
This article covers their expert guidance, insight, and tips to help you make fast progress in protein research.
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Reimagining Affordable Biosimilars
European Medicine Agency (EMA) biosimilar guidance provide recommendations for such predictive tools as supportive information for biosimilarity (17).
Thus, establishing biosimilarity requires an…
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EMA Confirms Standards for COVID-19 Treatment Evaluations
It provides guidance on the development of COVID-19 treatments; it reviews and requests data from developers; and it works as an advisor to the Scientific Advice Working Party (SAWP)/Committee for Med…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Automation software can provide guidance in ensuring that a single-use flow-path is properly connected, thereby saving time performing manual validation, Shave adds. The software can also generate aut…