Biopharmaceutical consultancy

© Fraunhofer ITEM

Many years of experience are an asset which the division of Pharmaceutical Biotechnology uses for consultancy services with regard to a wide variety of biopharmaceutical drug candidates over their entire development life cycle, from the initial idea to first-in-man trials.

Our Services

Selection of mammalian or microbial expression systems suitable for production of the desired molecule

Outline of appropriate cloning strategies

Assurance of technical and regulatory requirements for the production cell line/cell substrate

Scheme for master, working, and post production cell bank characterization

Evaluation and qualification of analytical service laboratories for cell bank and drug substance/drug product characterization

Development of cultivation and purification strategies

Identification and assessment of critical product and process attributes

ICH-associated/-compliant stability studies for biopharmaceutical drug substances and investigational medicinal products (IMP)

Design of protocols for transfer of processes and analytical procedures from and/or to third parties (CMOs, contract laboratories)

Due diligences of CMOs and contract laboratories

Strategy development, document preparation, and client support in preparation of and during scientific meetings/scientific advice with regulatory agencies

Preparation of CMC sections of IMPDs/medical writing