Viral Vector Services
Viral Vector Fill & Finish
We provide fill and finish services for AAV and adenovirus-based products.
The complete Fill and Finish service chain for Drug Products include formulation, aseptic Fill and Finish, terminal sterilization or aseptic processing, visual inspection, in-house sterility testing, labelling, packaging, and Qualified Person certified release.
Aseptically filled GMP-certified Drug Products can be used for clinical trials or for commercial purposes. Disposable components are used, and in-house release testing includes sterility testing and 100% visual inspection to ensure product safety.
We offer EMA-certified warehousing solutions for pharmaceuticals at controlled temperatures (RT, +4°C, -20°C, and -80°C) on-site. Once approved by our Qualified Persons, finished vials can either remain in our intermediate GMP storage or be promptly dispatched to clinics.
For AAV vectors, fill and finish are conducted in a dedicated aseptic suite (grade A/B, EU GMP) using an automated line validated for 2R and 10R vials, handling up to 1000 vials per batch.
Adenovirus vectors are processed in dedicated BSL-2 suites with an automated line also validated for 2R and 10R vials, up to 1000 vials per session.
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
Stability studies
- Stability study services for both AAV and adenovirus vector Drug Substances and Drug Products adhere to ICH guidelines. We conduct comprehensive studies encompassing study planning, analytical QC testing, and reporting, utilizing controlled cabinets to ensure the stability of these products.
With you all the way…
together, making advanced biologics, and tomorrow’s life-transforming therapies.
We deliver unparalleled end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for Drug Substances and Drug Products, from pre-clinical to clinical development and commercial phases.
We support our customers wherever they are on their journey, from early-stage development to commercialization. We are passionate, precise, and always close, together, making advanced biologics and tomorrow’s life-transforming therapies.
Pre-Clinical
Phase I
Phase II
Phase III
Commercial