
25
years of experience
Clinical samples, laboratory services, documentation
Fluart Innovative Vaccines Ltd. is an innovative pharmaceutical company that specializes in vaccine production, research and development. In addition to that the company is capable to produce small-volume biological products and API under GMP conditions, as well as to manufacture preclinical and clinical trial samples.
The company is able to conduct GMP-based contract manufacturing for its potential partners, which includes production activities, quality control, logistics and complete documentation.
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Our company provides for the following production and method verification services:
- Batch production for laboratory-scale
- Batch production for pilot-scale
- GMP-based large-scale production for commercial purposes
- GMP based API production for large-scale
- Preclinical sample production for studies
- Clinical sample production for phase I-III. studies
- Stability studies
- Analytical tests for product
- Fill and finish process
- Process test: simulation of clinical / commercial manufacturing processes (fermentation, mixing, filtration, filling, freeze drying)
- Management of technology transfer and scaling-up to clinical and commercial scale at dedicated manufacturing organizations
- Complete GMP documentation of production for all batch
35+
million vaccines produced
50+
Partners
POC: Zsolt Németh
Phone: +36204197020
Email: zsolt.nemeth[at]fluart.hu