Search results for " comparability"

Article Reimagining Affordable Biosimilars
Typical comparability exercises involve use of an arsenal of analytical and functional tools capable of characterizing various facets of these molecules (see Table I). Table I. Analytical a…

Article Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioproc…

Article 2019’s Top Bioprocessing Trends and What to Expect in 2020
2019 proved to be an exciting year for biopharmaceutical developers and process engineers, filled with both advancements and lessons. Considering how far the industry has come, what direction will 2…

Article The Evolving Role of Starting Materials in Cell and Gene Therapy
Manufacturing change validation/product comparability studies:Necessary to re-validate process with starting material that is essentially indistinguishable from original material in terms of quality, …

Article Best Practices for Selecting a Top-Quality Cell Line
…lection and process development and can lead to a scenario where titer may have to be sacrificed for comparability, Collins notes. It is also desirable to leverage a cell-line development tech…

Article A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape New ligands are being developed to meet the separation and purification needs of next-gen biologics. By Cynthia A. Challener …

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 Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins This study outlines methods for an alternative protein-polishing process for challenging proteins. …

Article Will My Buffers Work When Using an Inline Conditioning System?
Buffer preparation can be both time and space consuming and can easily become a challenge in biomanufacturing. In-line preparation of buffers from highly concentrated, single-component stock soluti…

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