Search results for " regulations" in Articles / App Notes
Article
Getting it Right from the Start in the Drug Development Process
Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maintain them at approved levels. As a result, the de…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
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Science Focus Fuels Successful Process Development for Startups
The process of drug development is a long one due to tight regulations by the regulatory bodies in the United States and Europe, and hence, biotechnology is not a suitable investment for an investor w…
Article
Supply Chain Challenges for Single-Use Systems
What will the logistics look like, and how will that impact lead times? The country that any product is manufactured in will have its own resources and regulations, which will affect the ability to in…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
Article
Achieving Process Balance with Perfusion Bioreactors
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.
By Cynthia A. Challener
MG/Stock.Adobe.com
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Article
The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
Increasing demand for biologics is drivin…
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
This article highlights 15 years of changes in biopharmaceutical manufacturing.
By Ronald A. Rader, Eric La…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
Handling sterile liquids in the pharmaceutical industry has traditionally relied on consistent techniques over the past 100 years, and changes in technology and regulations have been relatively slow, …
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…