Bioprocess development towards GMP (IDD)

Xendo Bioprocessing, Compliance, Engineering, Regulatory and Validation experts can fully participate as a multidisciplinary team in Integrated Drug Development (IDD) projects when working towards preclinical or GMP manufacturing. All the required expertise can be brought together to realize the manufacture of a preclinical batch or preparation for a tech transfer to a GMP facility. For specific expertise and laboratory activities Xendo’s collaboration with Batavia Bioservices guarantees all necessary support for

• Preclinical Batches     
• Bill of Materials
• Bill of Testing
• Process Validations
• Management of viral clearance studies
• GMP documentation tailor made to the transfer facility
• Process related regulatory documentation