Search results for " regulations"
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Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
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Best Practices for Selecting a Top-Quality Cell Line
Challenges with variability, complexity, and regulations
Selecting the optimum cell line must occur in the face of several challenges. For Fisch, the biggest hurdle to overcome is the varia…
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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…
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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
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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…
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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 …
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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
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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…
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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…