Masterarbeit

Determination and comparison of the regulatory requirements of human recombinant antibodies, Fab-fragments and aptamers regarding product and manufacturing quality

Dr. Erik Schneider (2010)

Language: English

Today, a total of twenty-two therapeutic antibodies are marketed in the US as well as in numerous other countries. This number is continuously increasing. Eight of these products have annual sales each of more than billion. These extraordinary annual sales lead to aggressive investment by the pharmaceutical industry in therapeutic antibody research and development by internal programs and acquiring companies that focus on this area. Due to this fact and driven by the low probability of generic threats, therapeutic antibodies are now the largest class of biological therapies under development. This development is still in progress. A number of more than 200 therapeutic antibodies is estimated as currently in clinical development. The pathways to establish the three key features for approval of therapeutic antibodies safety, efficacy and quality- today are well defined. In the light of the huge number of coming therapeutic antibody-based medicinal products drug regulatory affairs professionals as well as scientists in this field should be familiar with the regulatory requirements regarding the approval of therapeutic antibody-based medicinal products.

In this master thesis the regulatory requirements regarding the product and manufacturing quality of recombinant human antibodies are represented. The author lists all relevant guidelines and explains their application in conjunction to a theoretically development and manufacturing process. To provide a better insight the process is illustrated by several diagrams.

The great success and the huge number of coming therapeutic antibody-based medicinal products also generate problems. These kinds of products are expensive. Their high costs conflict with the financially stressed health systems, setting reimbursement by the payers as the major limiting factor of growth.

Therefore, in this master thesis the regulatory requirements regarding the product and manufacturing quality of Fab-fragment- and aptamer-based medicinal products as low cost alternatives to recombinant human antibodies are represented. For this the author lists all relevant guidelines and explain their application in conjunction to the related theoretically development and manufacturing processes. To provide a better insight several diagrams illustrate the processes.

Additionally, a comparison of the regulatory requirements regarding the quality of all three types of molecules is given. Finally, the impact of the different regulatory requirements on the costs of development and manufacturing of these molecules is described.

Pages: 49,
Annexes: 9 pages