Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Applicability of Scientific Guidelines to Allergens of Biological and Biotechnological Origin - A User Manual ***

Dr. Christa Lamping (Abschlußjahr: 2015)

Summary
There are only few allergen-specific guidelines available which provide advice on chemistry, manufacturing, and controls (CMC) issues concerning allergen extracts. Therefore, all further and in depths advice needs to be drawn from a multitude of regulatory documents. For recombinant allergens the allergen specific regulatory documents as well as all documents for biotechnological active substances and products can be applied. In total there is a considerable number of regulatory documents applicable to allergen extracts and recombinant allergens.
The objective of this master thesis is to provide guidance on the applicability of CMC-related existing regulatory documents to allergen extracts and recombinant allergens for diagnosis and immunotherapy of Type I allergies in humans.
The master thesis reflects on regulatory documents concerning the development, the manufacturing, the control and the stability of allergens while excluding all clinical issues from its scope. Considering the number of documents available, this reflection is not comprehensive and application of regulatory documents to the individual product always should be considered case-by-case.
Extensive information regarding allergen extracts and recombinant allergens can be found in the European Pharmacopoeia. Several general monographs joined by a wide range of general chapters provide advice on the quality of allergen products.
A variety of ICH/EMA guidelines are also applicable to allergen products. The guideline EMEA/CHMP/BWP/304831/07 is the core guideline for CMC related issues. Guidelines addressing biological/biotechnological products may apply partially to allergen extracts while being applicable to recombinant allergens to their full extent. Further guidelines may be applied based on the "principles" provided in these guidelines.
The reader can find a table in the Annex which lists the documents discussed in this review and a brief indication on their applicability. Therefore, the reader may use this thesis as a “user manual” to navigate through the range of regulatory documents in order to find the guidance she/he may find useful.
Pages: 73 pages
Annexes: 4 pages