With some medical interventions, immunogenicity is the whole point—hence the “good” immunogenicity provoked by vaccines. Immunogenicity is much to be avoided, however, when biotherapeutics are ...
With drug development costs increasing, it is now critical for the biopharmaceutical industry to focus its efforts on identifying new technologies and methods that can predict the efficacy and safety ...
The first patents of recombinant-DNA-derived biopharmaceuticals will expire in the near future, which should allow the marketing of 'generics'. With classical drugs, generics can be marketed on the ...
SAN DIEGO, Dec. 19, 2023 /PRNewswire/ -- Abzena, the leading end-to-end CDMO for complex biologics and bioconjugates, has co-authored a publication with the US Food and Drug Administration (FDA) ...
Determining the safety and efficacy of biotherapeutics is a key part of the drug development process. There is a need to develop assays that accurately and reliably detect and quantify immune ...
Serum samples for anti-panitumumab antibody testing were collected from mCRC patients enrolled in 4 panitumumab clinical trials (20050184, 20060277, 20050181, and 20050203). Patients in these studies ...
This article is based on a poster originally authored by Ebru Aydin Kurtulmus, Dagmar Hildebrand, Fiordiligie Casilag, Verena Banschbach, Jessica Heckmann, Sarah Schott, Marc Botcherby and Volker ...
The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown. Part 1 of this ongoing phase 2–3 trial was open ...
Pharmaceutical Technology spoke with John Pirro, senior director of large molecule bioanalysis at WuXi AppTec, which provides anti-drug antibody (ADA) and neutralizing antibody (Nab) assay development ...