mAb Development

Apr 25, 2016
By BioPharm International Editors
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
Apr 18, 2016
Linker technology and drug combinations play an important role in the efficacy of ADCs.
Apr 06, 2016
Inflectra is the second biosimilar to hit the market in the United States.
Apr 01, 2016
Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.
Apr 01, 2016
BioPharm International
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.
Mar 31, 2016
Adheren relies on chemical modifications, rather than genetic engineering, to create its cell-based immunotherapies.
Mar 22, 2016
The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.
Mar 01, 2016
BioPharm International
Experts in the field share some best practices for optimizing process economics in biomanufacturing.
Feb 17, 2016
FDA fast-tracked the monoclonal antibody based on early clinical data from a Phase I trial.
Feb 01, 2016
BioPharm International
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
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