Tue 13 Jun 2017 @ 11:00
Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of two new courses on monoclonal antibody-based products:
- ESS02: Essentials of Monoclonal Antibodies
- SUB12: Registration of Medicinal Products Based on Monoclonal Antibodies
Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Worldwide sales of mAb products are predicted to exceed $120 billion dollars by 2020. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, in laboratory analysis, and in the biotechnology industry itself.
ESS02 introduces the learner to monoclonal antibodies, explaining how mAb-based products work, how they are made, and the many uses to which they are put.
SUB12 addresses characteristic issues influencing the registration of medicinal products based on mAbs, for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture. This course focuses on distinctive issues in the production and testing of mAbs, in the context of relevant regulatory guidance. It discusses manufacturing quality, nonclinical and clinical issues, and aspects specific to radiolabelled mAbs. Finally, it identifies the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA.