Search results for "raw material variability"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
Raw Material Variability
Raw material variability may lead to quality compliance issues, process inconsistency, or bioprocess productivity problems. Many of these issues would be upstream in the cell-culture or fermentation s…
Article
The Evolution of Supply Chain Security: Increasing Focus on Raw Material Variability
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened raw material control.
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Article
Managing Risk in Raw Material Sourcing
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
By Agnes Shanley
Choosing excipients and supplie…
Article
Raw Material Variability: The Need for Deeper Process Understanding
This article shares some insights into how raw material variability is a potential source for process variation. The focus lies on chromatography resins.
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Article
Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Manufacturing
In this video, Christopher Woolstenhulme, Lead Analytical Scientist of Manufacturing Sciences at Cytiva, is interviewed by BioPharm International and provides insight into t…
Article
Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…