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MENARINI BIOTECH Biotechnology centre
Biotechnology (a fusion of biochemistry, molecular biology, cell engineering, chemical and process engineering, protein chemistry, immunology and other novel technologies) has in the last 25 years matured into a discipline discovering exciting and innovative new drugs often for previously untreatable conditions.
Menarini since 1986 has been at the forefront of this maturation of biotechnology in Italy, culminating in the establishment of a biotechnology centre of excellence at Pomezia. This centre is a beacon for biotechnology in Italy in being able to develop a biologic drug from the bench to pilot plant through to industrial scale production. The centre has embraced the highest standards of regulatory compliance (cGMP) and is licenced by the Italian Ministry of Health for the manufacture of clinical supply for human use. Menarini Biotech operates exclusively in the pharmaceutical sector and currently has several products in late phase clinical programmes (coronary infarction and oncology).
Menarini Biotech offers a secure, compliant and cost effective partner in the development and manufacture of biologic medicines derived from mammalian or microbial host and would be delighted to discuss how we can help you get your product to the market.
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PILOT AND INDUSTRIAL PLANTS
Menarini Biotech has the following ‘state of the art’ manufacturing and development facilities together with cutting edge analytical and protein charaterisation laboratories.
These are staffed with noted international experts in their fields fully committed to enhancing Pomezia as a biotechnology centre of excellence.
Cell culture and Fermentation
- Mammalian cells (somatic/hybridoma cells)
• Pilot scale 2-20-75 litres (stirred tanks, perfusion, hollow fibre, fluididsed bed, single use systems)
• Industrial scale 300-1500 litres (stirred tanks)
- Clean Rooms
- • Upstream Class D• Downstream Class C
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FROM THE LAB TO INDUSTRIAL SCALE
- Molecular biology
- Cell engineering
- Fermentation and downstream technologies
- Development and validation of bio-process with genetically-modified organisms
- State of the art characterisation of recombinant proteins
- Excellent Quality Control
- Full Quality Assurance
- Italian Ministry of Health Approved for clinical phase drugs for human use
- A secure, compliant, cost effective partner
- Consultancy on all aspects of drug development and registration
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