The VTU Manufacturing Science and Technology expert group offers the highest expertise in process characterization, technology transfer including a successful ramp-up and commercial manufacturing. We provide up-to-date regulatory, technical and scientific expertise customized to pharmaceutical manufacturers and process owners in the area of biologics production.

This includes:
Conceptual assistance and management of
Process characterization
Tech transfer
Process validation & commercial manufacturing
QbD concepts

Study design and documentation for
Process characterization
Process validation incl. OPV/CPV
Cleaning validation
Elemental impurity / extractables and leachables

Writing of assessments, SOPs, protocols and reports
Process control strategy / contamination control strategy (Annex 1)
Health authority inspection xe2x80x93 preparation & management

Our highly experienced personnel assists in establishing integrated manufacturing processes leading to successful submission.