Our Fill and Finish Services
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. The environments in the two aseptic dispensing rooms fulfill the requirements for handling hazardous products/biologics in the GMO II group. Intermediate warehousing of the Drug Products at various temperatures (RT, +4°C, -20°C and -80°C) is provided on the same European Medicines Agency (EMA) certified site.
Fill and Finish Capabilities
- Two dedicated filling lines for BSL1 and BSL2 products
- Fully automated filling machines with 100% disposable product contact parts
- Range of volumes: from 0,5 mL to 100 mL
- Vial-sizes from 2 mL to 100 mL with custom stoppers and capsules
- Batch size ranges from 50 to 10 000 vials
- BSL1 up to 10 000 vials
- BSL2 up to 1000 vials
- Inhouse safety testing including sterility testing and 100% visual inspection
Examples of biologics for aseptic Fill and Finish
Drug Products can be used e.g. in gene therapies, immuno-oncology and vaccine applications.
- Viral Vectors: AAV, Adenovirus and other BSL2 class Viral Vectors.
- Plasmid DNA
- Recombinant proteins and protein complexes
- Dilution buffers
- Placebos
Future Filling Line for Recombinant Proteins and Plasmid DNA
Our new filling line for recombinant proteins and plasmid DNA, equipped with Restricted-Access Barrier System (RABS), will be in operation early 2021. The fully automated new filling line can be used for batch sizes up to 10 000 vials (2R and 10R). This investment is part of our commitment at Biovian to offer seamless customer service in order to support your individual clinical and commercial needs.
