Below is a listing of our services and quality control.

Services

  • Manufacturing of GMP-grade and GMP-comparable AAV and LV vectors
  • Long-term stability testing services consistent with the duration of the Phase 1/2 study
  • Device compatibility and short-term stability studies
  • Manufacturing of GMP-grade and non-GMP grade excipient
  • Regulatory support for Investigational New Drug (IND) applications
  • Letter of cross reference to our Drug Master File (DMF)

Quality Control

  • Bioburden/Sterility
  • Bacteriostasis/Fungistasis
  • Mycoplasma
  • Endotoxin
  • Replication Competent AAV
  • Replication Competent LV
  • Adventitious agents
  • Other