Search results for " variability" in Articles / App Notes
Article
Considerations for Improving Outcome in Biopharmaceutical Process Development
For example, things like streamlining operations, optimizing titers and yields, evaluating cell lines and cell culture media, and controlling raw material variability can play a pivotal role in obtain…
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
Good Manufacturing Practices: Challenges with Compliance
Biologics are complicated to work with because they come from living materials, which have inherent variability. Therefore, the biggest challenge from a GMP perspective is maintaining consistent produ…
Article
The Importance of Partnering for Bioanalytical Studies
The bioanalytical methods need to be robust enough to work with the variability that comes with such a diverse set of samples.
It is thus important to anticipate these challenges early on while…
Article
Free On-Demand Webinar: Smart Process Development of Chromatography Steps
Management of process variability through deeper process understanding
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Use of high-throughput methodologies
This toolset can help you overcome some of the challenges with time limit…
Article
Tools and Processes for Mature and Emerging Therapies
A digital data exchange collaboration program between Cytiva and Amgen was developed to understand of the relationship between raw material variability and manufacturing process performance. The compa…
Article
Emerging Therapies Test Existing Bioanalytical Methods
…n the guidance, namely demonstrating that the method measures the intended analyte, evaluating assay variability, the range in measurements that provide reliable data, and the effect of sample collec…
Article
Scale-Up Model of a mAb Process from Microbioreactor to XDR-1000
All investigated bioreactor systems displayed similar trends over time and acceptable variability between cultures for viable cell density and viability profile, product titer, lactate, and product qu…
Article
Automating the Biomanufacturing Process
Control has been manifested mainly in minimizing manual interactions and preventing operator error, to prevent variability in production and in product quality that would require correction.
Today…
Article
An Analytical Approach to Biosimilar Drug Development
That is due to the natural variability and inherent complexity in manufacturing of biologics for which the demonstration of identical quality attributes (pharmaceutical equivalence) as required by the…