The immunogenicity of biopharmaceuticals used in clinical practice remains an unsolved
challenge in drug development. Non-human primates (NHPs) are often the only relevant …

Selection of a pharmacologically responsive species can represent a major challenge in
designing nonclinical safety assessment programs for many biopharmaceuticals (eg …

Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from
serious diseases due to their high specificity for their target and low potential for off-target …

The development of mAbs remains high on the therapeutic agenda for the majority of
pharmaceutical and biotechnology companies. Often, the only relevant species for …

the Medicines Evaluation Board in Utrecht, The Netherlands, we had access to drug
registration files with every animal study done to support marketing authorization of all mAbs …

Selecting a pharmacologically relevant animal species for testing the safety and toxicity of
novel monoclonal antibody (mAb) therapies to support clinical testing can be challenging …

Biopharmaceuticals have the potential to raise an immunogenic response in treated
individuals, which may impact the efficacy and safety profile of these drugs. As a result, it is …

A total of 26 toxicology studies performed with biological drugs (monoclonal antibodies and
related immunoglobulins as well as recombinant human proteins) in the primate have been …

Unlike conventional chemical drugs where immunogenicity typically does not occur, the
development of anti-drug antibodies following treatment with biologics has led to concerns …

It has been predicted that the use of non-human primates (NHPs) is going to increase
considerably in the development of monoclonal antibodies (mAbs). Opportunities exist to …