Cerbios’ state-of-the-art cGMP production facilities comply with international regulatory requirements and guarantee a Swiss quality assurance system with extensive technical and regulatory expertise. A multidisciplinary team of experts from the R&D, Manufacturing and Quality Assurance departments involved from early process development to cGMP manufacturing enables a flawless transition from preclinical to advanced clinical phases and commercial.
Moreover, process development activities are performed using a QbD approach with the adoption of DOE coupled to PAT instrumentation to allow full process characterization minimizing project risks. Advanced analytical competencies using state-of-the-art instrumentation necessary for in-depth biopharmaceutical product characterization are available including formulation development. Cerbios’ fully equipped Quality Control laboratories support all projects from method development through method validation to cGMP batch release.