LuinaBio

We are a biomanufacturing company based in Australia.

We offer a full suite of cGMP services for the production of Api using bacteria and yeasts. More information can be found on our website http://www.luinabio.com.au/ .

Services
LuinaBio is Australia’s most experienced biopharmaceutical CDMO’s. We perform GMP manufacture of
• Recombinant proteins & vaccines
• Synthetic molecules
• Human & veterinary products
• Material for pre-clinical, clinical & market.
• Aerobic and fully anaerobic fermentation

More specifically Luina carries out microbialaerobic and anerobic fermentation, cell banking, vaccine production, process development ,analytical services and stability studies.

Experience
Through its 20 years’ experience LuinaBio has provided development and production services to clients based in America, Asia, Australia and Europe. Our clients include biopharmaceutical development companies, research institutes, veterinary drug companies and Universities. We have been involved in a wealth of different projects.
Recent projects include:
• Recombinant protein from E.coli for a phase 3 trial in the US under IND
• Recombinant protein from E.coli conjugated to a carbohydrate for a phase 2 in the US under IND and phase 2/3 trial in the EU
• Fermentation source dsemisynthetic carbohydrate for a phase 3 clinical trial in Asia
• Whole cell killed vaccine for a phase 2 trial in the US and Australia under IND

Key facilities and equipment
• Fermentation at 5L, 30L and 500L scale
• Fed batch capabilities
• Cell recovery by discrete continuous centrifugation or ultrafiltration
• Ultrafiltration
• High pressure homogeniser for cell rupture
• Chromatographyo
 -AKTA100systemo
 -AKTABiopiloto
 -AKTABioprocessskido
 -Chromatographycolumnsto200L
• Final product filtration
• Lyophilisation bulk and stoppering up to 40L

Why work with us
• 20 years’ expertise in biopharmaceutical production from bacterial/yeast cell lines
• GMP material for:
 -Pre-clinical 
 -ClinicalPhase1,2&3
 -Market
• Highly cost competitive
• Extremely flexible with fast access and turn around times
• Access R&D tax credit (43.5% up front govt. rebate)
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Locations


Australia
LuinaBio
2806 Ipswich Road
Darra, QLD  4076
Australia, Austalia / New Zealand

Contacts


Massimiliano Rossetto
Business Development Director

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