Search results for " monoclonal"
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Data were available for 15 measurements over 16 time points for 20 cultures (19 Chinese hamster ovary cell lines) making the same recombinant monoclonal antibody (mAb) giving a 240-dimensional data se…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The extent of glycosylation can also vary depending on the basal and feed media, even with a single clone producing a single monoclonal antibody, or single basal media with varied feeds.
Effects of…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
To date, the majority of monoclonal antibodies (mAbs) have generally targeted a particular antigen; however, there are several additional antibody formats currently in the development pipelines of pha…
Article
Antibody Fragments and Their Purification by Protein L Affinity Chromatography
A majority of such molecules are monoclonal antibodies; however, many new entities are antibody fragments. Due to their structural, physiological, and pharmacological properties, antibody fragments of…
Article
Best Practices in Qualification of Single-Use Systems
Figure 1 depicts a typical monoclonal antibody (mAb) drug manufacturing process. Single-use bioreactors are widely used in cell line expansion, and the use at production scale is increasing, notably i…
Poster
Purification platform challenges and strategies for handling of "tricky" MAbs
In the work presented here, capture using high-capacity protein A medium (resin) was followed by polishing using a novel cation exchange chromatography medium.
Article
Ensuring the Quality of Biologicals
has established general monographs that cover common quality attributes and that are applicable to a specific class of biologicals such as monoclonal antibodies (mAbs), rDNA products, or vaccines for …
Article
Modular Manufacturing Platforms for Biologics
By using modularization and the other aforementioned technologies such as continuous manufacturing, facilities to produce monoclonal antibodies (mAbs) can also be operational 12 months after project i…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
This structure replaces specific divisions for monoclonal antibodies and for other proteins staffed by more specialized reviewers. The change should help OBP manage its workload more effectively as bi…