Adenovirus Vector GMP Production Services
From Viral Vector GMP Production
Adenoviruses are attractive tools for gene therapy, including immuno-oncology, because of their well-defined biology and characteristics including the possibility for large gene inserts. Biovian has proven expertise in adenovirus vector process development, GMP production, and analytics. Since 2004, we have developed processes and have manufactured over 40 clinical adenovirus GMP batches for our clients. Biovian supports adenovirus vector production in both adherent cell cultures and suspension cell cultures. Scalable technologies enable a straightforward transition to GMP production. Sourcing GMP-grade raw materials and consumables from qualified material providers are included in the services. The One-Stop-Shop concept is finalized with bio-safety level 2 class aseptic filling in a grade A/B production suite, followed by clinical labeling, GMP storage, certification of GMP compliance and Qualified Person (QP) approved release.
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Adenovirus vector upstream processes
Adenovirus vector upstream processes
The adenovirus vector upstream processes comprise 1) mammalian cell culture, e.g. HEK293, A549 in adherent or suspension culture, 2) transduction with adenovirus vector, 3) cell harvest and lysis, and 4) analysis of harvest. The selection of the producer cell line and culture type can be made together with our experts.
Suspension cell culture – adenovirus vector
Adenovirus vector production in suspension cultures enables easy upscaling and reduces process costs. Producer cell lines such as HEK293 cells can be adapted to suspension culture and they can grow in serum-free media, which enhances the safety profile. For small-scale suspension cultures shake flasks with various capacities can be used. For large-scale suspension cultures, the bioreactor options at Biovian include single-use stirred-tank bioreactors, where the GMP volume is up to 200 L. Depending on the project perfusion, fed-batch or batch cultivation will be applied.
Adherent cell culture
Adenovirus vectors can be produced in adherent cell cultures using T-flasks or multilayer flasks such as hyperflasks or cell stacks. Alternatively, adherent cell cultures can be carried out in bioreactors, where the options at Biovian are packed-bed bioreactors or single-use bioreactors with microcarriers. Adherent cultures require tissue-culture treated vessels and repeated passaging, but allow for easy visual inspection under the microscope.
Adenovirus vector downstream processes – GMP
Biovian’s platform approach to downstream processing of adenovirus vectors comprise 1) tangential flow filtration, TFF, for removal of impurities and buffer exchange 2) a capture step, where adenovirus vectors are purified and concentrated 3) polishing chromatography 4) concentration and formulation with TFF, or dialysis for low volumes, and 5) analysis of the Drug Substance according to regulatory requirements.
For small-scale production fast gradient ultracentrifugation- based method can be used to purify the clarified adenovirus vector harvest. The final filtration is performed using a 0.2 µm filter to fulfill the sterility requirement for adenovirus DS.
Adenovirus vector Quality Control assays
Biovian offers full access to QC analytics for the demonstration of the quality of adenovirus vector GMP batches. We use compendial assays and perform sample-type specific validation to comply with all regulatory requirements for adenovirus vectors for human use. Development or technical transfer of product-specific analytical methods, as well as validation of these methods, is part of our services.
Adenovirus vector Fill and Finish
Aseptic Fill and Finish of adenovirus vectors is performed in dedicated suites that fulfill BSL 2 requirements. The automated filling line is validated for 2R and 10R vial-sizes up to 1000 vials per session. The tubing, filling needle and other assemblies are fully disposable. In-house release testing services include sterility testing, and a 100% visual inspection is performed after each filling to ensure the safety of the adenovirus vector Drug Product in each vial. Before shipping the adenovirus vector products for use in clinical trials are certified by one of our Qualified Persons. We also provide intermediate GMP warehousing of the Drug Products at various temperatures (RT, +4°C, -20°C and -80°C) on the same European Medicines Agency certified site.
Adenovirus vector GMP documentation package:
- TSE/BSE certificate
- Certificate of analysis
- Batch certificate and certificate of GMP compliance
- GMP production summary report
CMC documentation
- IND/IMPD CMC documentation support upon request
Adenovirus vector stability studies
Stability testing of adenovirus vector Drug Substances and Drug Products is conducted at Biovian under controlled conditions according to ICH guidelines. The stability study services include study planning, analytical QC testing and reporting.
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