Naobios at a glance

Over 200 years of combined experience in Process Development and GMP manufacturing of virus-based products

Strong experience with various types of cells and viruses

  • Cell lines: Vero, MRC-5, BHK-21, EB66®, CAP cells, AGE1®CR
  • Viruses: Measles, Rubella, Poliovirus, MVA, Influenza, NDV, Sindbis

Manufacturing in BSL2 and BSL3 suites

Aseptic Process Manufacturing in Grade A in B and Isolator in C with Aseptic Process Simulation

Manufacturing up to 200L STR or 200m2 fixed bed bioreactor

Able to deliver a drug product within 11 months (using a process developed in house)

Strong experience in development and GMP manufacturing of microcarrier based processes using Vero cells: more than 100 USP runs in STRs (glass and SUB) at various scales of production

Project team covering development & GMP manufacturing phases – seamless transfer of developed processes to GMP

Experience with the iCELLis system (nano scale, iCELLis 500+) under GMP

Manufactured over 10 virus seeds and over 20 drug substance batches for clinical Phases I to III

Process & analytical method validations for clinical Phase III DS Production

GMP Production in compliance with EMA, WHO and FDA regulations

Management of up to 4 GMP Manufacturing areas & 5 projects in parallel