Produkt | 02.07.2019 - 15:52 UhrManufacturing Science & Technology
- (Mock-) Audits
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.
Conceptual assistance and management of
Process validation & commercial manufacturing
Study design and documentation for
Process validation incl. OPV/CPV
Elemental impurity / extractables and leachables
Writing of assessments, SOPs, protocols and reports
Process control strategy / contamination control strategy (Annex 1)
Health authority inspection \xe2\x80\x93 preparation & management
Our highly experienced personnel assists in establishing integrated manufacturing processes leading to successful submission.