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Taking your viral vector manufacturing to commercial scale
The last 4 years have seen an increased number of clinical studies in both cell and gene therapies, carrying high hopes.
The growing demand for targeted therapies creates high needs for specialized capacities.
If you are looking to outsource your viral vector commercial manufacturing to a reliable CDMO (Contract and Development Manufacturing Organization) partner, check out how Novasep can address all your needs.
- 20 years of viral vector CDMO (Contract Development and Manufacturing Organization) experience
- 2 manufacturing sites in Belgium: Gosselies and Seneffe
- More than 100 cGMP batches produced and released in the last five years
- AAV vectors
- Lentivirus vectors
- Adenovirus vectors
- Other types of viral vectors: HSV (Herpes Simplex Virus), VSV (Vesicular Stomatitis Virus)
Therapeutic indication examples:
- Neuromuscular diseases
- Ocular diseases
- Hematologic diseases
- Cardiovascular diseases
- Production process
- CQA (Critical Quality Attribute)
- CPP (Critical Process Parameter)
- CMA (Critical Material Attribute)
- Preliminary Control Strategy
- PVMP (Process Validation Master Plan)
- Facility and equipment qualification
- Validation studies
- Final Control Strategy
- PPQ (Process Performance Qualification) campaign
3. Continued process verification
- Analytical methods
3. Validated methods
Commercial manufacturing and release
Senrise-IV for Drug Substance: commercial production facility for viral vectors
- 2 manufacturing lines
- Up to 2,000L
- Adherent and suspension modes
- Seneffe, Belgium
Senefill for Drug Product: commercial facility for aseptic Fill & Finish
- State-of-the-art facility
- Automatic filling
- Up to 10,000 vials per session
Want to learn more about our capabilities?
Download our brochure!