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