Dr. Martin Zühlsdorf

Qualification of pharmaceutical equipment

Responsible for implementation of ICH Q3D guideline, technology transfers (establishing new CMOs, reviewing analytical and process validation documents), integration of acquired products into the portfolio, preparation of SOPs

I was responsible for Module 2.3 and Module 3 of several medicinal products (capsules, tablets, sugar-coated tablets, film-coated tablets and sterile ophthalmic solutions) with about 15 national marketing authorisations in Europe. I have experience in handling APIs with CEPs, ASMFs, in-house monographs as well as atypical APIs. Furthermore, I was part of the ICH Q3D implementation team.

Currently, I am finalizing the refinement of a potentially pharmaceutic relevant protein structure which will likely result in a very interesting publication. My second project is a review on a class of serine proteases I have worked on.

Quality assurance; assessment of resources; got to know GMP-environment; updated safety data sheets

Molecular biology, structural molecular biology, protein expression in E. coli, protein purification

Molecular biology and structural biology