Adeno-Associated Viral Vectors GMP Manufacturing services
The Innovavector’s manufacturing site, AIFA-inspected and licensed, is able to supports AAV vector production in both adherent cell cultures and suspension cell cultures, able to delivery from 12L to 50L upstream scale.
The facility consists of classified areas from Grade D to grade A in which Upstream and Downstream are carried out in compliance with Eudralex Vol. 4, Part I, III, IV and related Annexes, as well as semi-automated aseptic filling of Drug Products.
Full GMP documentation and detailed batch records are provided, and our Qualified Persons are at your service to ensure that products are certified for clinical use before shipping.
AAV vector suspension serum free process
Upstream
- mammalian cell culture, e.g. HEK293
- cell amplification
- transfection with plasmids
Downstream processes
The AAV vector downstream processes entails:
- Broth clarification
- Tangential Flow Filtration (TFF)
- Purification by chromatography (affinity and AEX)
- Formulation and sterile filtration of Drug Substance
Aseptic Fill& Finish
The AAV vector aseptic fill&finish entails:
- Sterile Filtration of Drug Product bulk
- Semi automated vials filling from 1 to 5 mL
- Vials crimping
Fill and Finish for AAV vectors is performed in a dedicated aseptic filling suite, grade A/B (EU GMP). The semi-automated aseptic filling line for AAV vectors is validated for 3 mL vial-sizes up to 450 vials per batch. The Drug Product may either be kept in intermediate GMP storage at Innovavector or be directly shipped to the clinic, once the batch has been released by our Qualified Persons.