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Viral Vector GMP Production Facility Service
The state-of-the-art production facility allows for flexible viral vector production scenarios. The cleanroom class C (EU GMP) and biosafety level 2 facility is designed for the manufacturing of GMP-grade viral vectors. The space design follows a modular ballroom concept and unidirectional process flow. The equipment are mobile, allowing for easy reconfiguring, and the operations are performed according to one-way process principles from incoming to outgoing material. Production is campaign-based – a single product is produced at a time, and disposable materials and closed systems are used. Open processes are executed in biosafety cabinets with HEPA 14 filters, with air exhaust directly out of the building.
Utilities
- The production area is equipped with HVAC technology with a single-pass ventilation design, without any recirculation of air.
- The facility includes a restricted passage with electronic access control and pressured air-locks for material and personnel entry and exit. The air-locks are composed of two-parts (D- and C-grade) and controlled with inter-locks. HEPA filters are placed across the operating area and air-locks.
- Other utilities include gas supplies (CO2, O2, N2) and compressed air outlets.
- The facility is equipped with 24/7 monitoring and an alarm system.
Track record in viral vector development and manufacturing
- Biovian has been developing viral vector processes since 2004.
- Over 40 clinical GMP batches have been manufactured, including batches for clinical phases up to Phase III as well as commercial validation batches.
- Longest-lasting customer relationship >10 years and still active.
Cell Banks and Virus Seed Stocks
- Research Cell Bank
- Master Cell Bank and Working Cell Bank
- Master Viral Seed Stock and Working Seed Stock
Upstream Processes
- Suspension Cell Culture in single-use bioreactors – up to 200 L
- Adherent Cell Culture in multilayer flasks, packed-bed bioreactor and single-use bioreactors on microcarriers
Downstream Processes
- Ultracentrifugation-based Downstream Processes
- Chromatography-based Downstream Processes
- Comprehensive purification solutions – chromatography, membrane processes, Tangential Flow Filtration processes (TFF)
Aseptic Fill and Finish
- Formulation and final Drug Product manufacturing
- Automated Aseptic Filling line for live Viral Vectors
- Typical batch sizes 200 – 1000 vials
Quality Assurance and Quality Control
- Product-specific assays
- Impurity analysis
- Cell-based assays
- Microbiological QC and safety assays (sterility, bioburden, endotoxin etc.)
- QP Certification and full GMP documentation