Search results for "raw materials"
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Ensuring the Biological Integrity of Raw Materials
Although contamination can occur from the cell culture itself or from labware and the laboratory environment, raw materials are the most significant source of contamination, which can lead to false re…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Starting material variability
The raw materials for allogeneic cell therapies cannot be manufactured on demand, but instead, rely on a network of volunteer donors. This creates variability in cell…
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Raw Material Variability
It would seem that raw materials used in bioprocessing operations are a relatively straightforward factor given the overall complexity of commercial manufacturing. In fact, they give a surprisingly di…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The two raw materials only differ in that resin B has a higher PE molecular weight and comonomer level.
Figure 3 summarizes the results of tracking TBPP-related species in samples from the entire …
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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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Managing Risk in Raw Material Sourcing
“Plant-of-origin information and transparency regarding the source of raw materials is essential for traceability,” he says.
Avantor has globalized and standardized quality systems at its faciliti…
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Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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Raw Material Variability: The Need for Deeper Process Understanding
Principles and methodologies for biopharmaceutical development and manufacturing are well established today. However, the increased molecular diversity and drive for higher productivity brings new c…
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Upstream Processing: Biochemicals and Raw Materials
Experts reveal how to identify the “right” biochemical, the process of sourcing biochemicals, sourcing challenges, and what industry professionals should know about the space.
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Other raw materials used in the manufacture of biotherapeutics, especially those of animal and human origin, could also present a viral safety risk.
Traditionally, the management of inadvertent vi…