Search results for " variability" in Articles / App Notes
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
zli…
Article
Impurity Testing of Biologic Drug Products
Validation of the method will then serve to confirm the robustness of these elements and assess the variability introduced by different analysts and equipment.
Both the number of replicat…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Being Thorough When Transferring Technology
Due to the inherent variability and complexity of biologics, the design space and strategy should take into account future scale-up considerations and risks. This can be met with qualified scale-down …
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Optimize Column Loading Strategy to Gain Productivity in Protein Purification
Are you looking for a way to improve productivity in your affinity chromatography step? Have you ever applied the concept of variable loading to gain productivity? By varying residence time (RT) ove…