Process validation is an integral part to prepare drug marketing authorization. The Boehringer Ingelheim BioXcellence™ service offering for process validation covers all related disciplines. Our highly professional process validation group provides a lean but state-of-the-art validation strategy for biotech drug substances—from working cell bank to cell cultivation and harvest through protein purification and formulation to drug product processes—whether for lyophilized or liquid dosage forms.
Our validation services also include supportive validations such as lifetime studies for chromatography resins and membrane systems, hold time validations, refiltration etc. and are performed by our process validation specialists. They are involved starting from the end of process development to commercial scale production including process qualification runs. Boehringer Ingelheim BioXcellence™ process validation also provides support for regulatory submissions. During commercial manufacturing, our validation experts are involved in change control and deviation procedures to keep the drug production process in a validated state.
At Boehringer Ingelheim BioXcellence™ we pride ourselves on our biopharmaceutical validation know-how. Each year several new processes or process variants are successfully transferred to routine manufacturing. For our clients' convenience and to facilitate regulatory filings, all process validation documents can be provided in English.