List view / Grid view

Immunogenicity

Filter the results

 

article

Immunogenicity: anticipating and avoiding issues for biopharmaceutical development

21 September 2015 | By

All biopharmaceutical products are associated with an intrinsic potential to induce immune responses in treated subjects. Regulatory agencies expect sponsors to evaluate and mitigate these risks during product development, applying a strategy that addresses product- and patient-related factors. Overall, understanding and controlling immunogenicity-related risks are attainable objectives, and approvability should…

article

Developing antibody therapeutics

10 June 2015 | By

Monoclonal antibodies have come of age as therapeutics; there are now more than 30 antibodies on the market and over 200 in clinical trials. The attractions of therapeutic antibodies lie not only in their potential to make potent drugs but also their relative low risk in comparison to small molecule…