Recombinant proteins as active ingredients of biotechnologically-derived medicinal products (biopharmaceuticals) are manufactured by applying complex multi-stage processes:
These processes are usually roughly divided into the stages of Upstream Processing and Downstream Processing.
Host cells carrying the nucleotide sequence of the gene of interest are cultivated in bioreactors (culture vessels) and by this means are stimulated to express the polypeptide for which they code.
The active substance is subjected to extraction, purification and concentration. Additionally, measures are taken to prevent transmission of infectious agents and thus ensuring adequate safety.
Alternatively to established cell lines (host cells mentioned above), transgenic organisms like plants and a number of animal species may be used to gain recombinant proteins.
In contrast to medicinal products derived from chemical synthesis, recombinant proteins exhibit both a complex molecular structure and microheterogenicity.
Consequently, biological and immunological characterization have to include a broad range of techniques that cover different analytical aspects such as structure, post-translational modifications, product-specific variants, impurities and biological activity.
Marketing authorisation of medicinal products derived by recombinant DNA technology
Marketing authorisation of medicinal products derived by recombinant DNA technology within European Economic Area (EEA) is performed by using the centralised authorisation procedure , coordinated by EMA (European Medicines Agency).
Expert group „Biologicals -Quality“
Within the AGES/Austrian Medicines and Medical Devices Agency scientific evaluation regarding manufacture and quality of medicinal products derived by recombinant DNA technology, is performed by assessors of the expert group Biologicals - Quality
The group’s core competencies in respect with recombinant therapeutic proteins are:
- Assessment of the quality part in centralised procedures with Austria as Rapporteur or Co-Rapporteur
- Assessment of the IMPD within clinical trial applications
- European and national scientific advice procedures (EMA-SA & NASA)
- Involvement in the Biologics Working Party (BWP)
AGES/Austrian Medicines and Medical Devices Agency holds expertise regarding recombinant proteins with the main focus on recombinant coagulation factors, monoclonal antibodies and fusion proteins as well as biosimilars. Consequently, AGES is frequently assigned to scientific evaluation within EMA-Scientific Advice procedures as well as centralised authorisation procedures.
Christian Mayer: +43 (0) 50555 36826
Created: 12.11.2014 | Page last modified: 03.10.2018