Search results for " variability"
Article
Quality by design in biotherapeutics purification white paper
One of these challenges is how process developers might gain a deeper understanding for sources of variability and set mitigation strategies. This white paper summarizes information around resin varia…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
Serum is used to inactivate the trypsin, but lot-to-lot variability and the instability of the serum may fluctuate the degree of trypsin inactivation, and thereby result in less control over the host-…
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Remote Monitoring and Big Data Advance Upstream Automation
Such innovations, Vann stresses, are critical to increasing digital maturity to the point where predictions can enable adaptation to inherent process variability so that consistent performance and qua…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
When it comes to raw material variability, process developers face a range of challenges as a result of molecular diversity and a need for higher productivity, such gaining a deeper understanding for …
Article
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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Cell-Culture Advances Test Bioreactor Performance Models
Mistretta agrees that variability of single-use systems does impact cell culture, but Amgen has been able to rapidly detect and determine the root cause for this cell culture variation through the acc…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Biopharmaceutical glycosylation variability is determined by manufacturing bioprocess conditions (1). Large-scale mammalian cell culture is used for the manufacture of all therapeutic glycoproteins (T…
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Nurturing Knowledge from Disparate Data Streams
Because biologic drug substances are produced in cells or microorganisms, their structures and compositions can vary slightly from batch to batch, leading to inherent variability, according to Tiffani…
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QbD Improves Cell-Culture Process Control
Even in a bioprocess with identical process settings, however, variability in end-product quality output is still likely to occur due to the variability of inputs, such as the raw materials and the li…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
There were many questions about dealing with variability in raw materials, evaluation of stability, and addressing unique supply chain issues.
Bryan Silvey, senior director for quality compli…