Search results for " variability"
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…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
Article
Leveraging Data for Better Biopharmaceutical Process Control
…ess so that changes in peak shape can be used to better understand the underlying buffer preparation variability or to anticipate packing problems that might have been overlooked.
BioPharm: In…
Article
Making the Move to Continuous Chromatography
Continuous chromatography is not recommended when a chromatography step is not well understood, is expected to experience significant variability, or may be modified later, according to Najera. “One t…
Article
Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
By Feliza Mirasol
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