Capabilities

GLP Tox/Bio Animal Study

Preclinical R&D

  • ​Plasmid production

  • Plasmid testing​

  • AAV development​

  • Lockdown for Tox​

  • Preclinical material manufacturing​

  • Assay development (optional)

Phase 1/2 Clinical Study

Process Development

  • Production/Purification

  • Cell line improvements​

  • Tech transfer

  • Oversee cGMP​

  • Assay development (product)​

  • Preclinical material manufacturing​

GMP Production & Testing

  • Release testing​

  • Cell, plasmid banks​

  • Clinical trial material​

  • Stability testing

  • Compendial methods

Pivotal Clinical Study

Pivotal Process

  • Viral clearance​

  • Design space definition​

  • Validation​

  • Manufacturing​