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AAV Vector GMP Production Services
Adeno-associated virus (AAV) vectors are among the most frequently used viral vectors for gene delivery. Biovian’s support for AAV vector projects ranges from process development to clinical and commercial GMP production. We provide technologies for both adherent and suspension cell cultures that enable controlled upscaling. Development or technical transfer of analytical methods is part of our in-house services, as well as automated aseptic filling of viral vector 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.
The AAV vector upstream processes comprise 1) mammalian cell culture, e.g. HEK293, or Sf9 insect cells 2) transfection with plasmids or transduction with baculovirus, depending on the selected approach and serotype 3) cell harvest and lysis, and 4) analysis of harvest.
Biovian provides assistance with the selection of the producer cell line, as well as of culture type, based on the AAV serotype and other factors and needs. Access to some of the newest technologies and production platforms can be provided through our partnerships.
Suspension cell culture – AAVSuspension cultures can be easily upscaled, as the limiting factor for cell growth is the concentration of cells in the medium. If needed, suspension cells can be cultured in serum-free media and are thus free from bovine-derived impurities such as TSE and BSE.
Adherent cell culture – AAVAdherent cell culture is applicable for most cell types. Some AAV vector constructs only produce good yields in adherent cultures. Growth monitoring of adherent cell cultures can be done visually under the microscope. Adherent cell growth is limited by surface area, which may limit product yields.
AAV vector downstream processes – GMPThe AAV vector downstream processes comprise 1) affinity chromatography for AAV capsid binding 2) anion exchange chromatography for removal of empty capsids and host cell contaminants 3) optional polishing step 4) exchange to formulation buffer using tangential flow filtration, and 4) analysis of Drug Substance. Biovian’s multi-step platform purification process is compatible with multiple AAV serotypes. For small-scale batches ultracentrifugation-based purification is available.
AAV vector quality control assaysBiovian provides full access to analytical methods that demonstrate the quality attributes mandatory for AAV vector GMP batches. Compendial assays and sample-type specific validation are performed to meet all regulatory requirements of AAV vectors for human use. Development or technical transfer of product-specific assays, including validation of assays, is part of our expert services.
AAV vector Fill and FinishFill and Finish for AAV vectors is performed in a dedicated aseptic filling suite, grade A/B (EU GMP). The automated aseptic filling line for AAV vectors is validated for 2R and 10R vial-sizes up to 1000 vials per batch. The finished vials may either be kept in intermediate GMP storage at Biovian or be directly shipped to the clinic, once the batch has been released by one of our Qualified Persons.
AAV vector QA documentation package:- TSE/BSE certificate
- Certificate of analysis
- Batch certificate and certificate of GMP compliance
- GMP production summary report
- IND/IMPD CMC documentation support upon request
The stability testing services include the study plan, analytical QC testing and reporting. Stability testing of AAV vector Drug Substances and Drug Products is conducted at Biovian according to ICH guidelines. We have controlled cabinets for stability studies according to ICH guidelines.