Supporting you from bench to clinic to market
LuinaBio is one of
Australia’s most experienced
biopharmaceutical contract
manufacturing organisations.
2806 Ipswich Road, Darra, QLD 4076
www.luinabio.com.au
Phone: +61 (07) 3273 9176
Fax:
+61 (07) 3375 1168
Manufacturing Capabilities
Our capabilities
• cGMP Manufacture of APIs
• Microbial/Yeast Fermentation
• Small Molecule Synthesis
• Process Development/Scaleup
• Cell Banking
• Stability Testing
• Licensed by the TGA and APVMA
Processes and Equipment
• Fermentation at 5l, 30l and 500l scale
• Fed batch capabilities
• Cell recovery by discrete or continuous
centrifugation or ultrafiltration
• Ultrafiltration
• Microfluidics high pressure homogeniser for cell
rupture
• Chromatography
– AKTA 100 system
– AKTA Biopilot
– AKTA Bioprocess skid
• Chromatography columns to 200l
• Final product filtration
• Lyophilisation bulk and stoppering up to 40l
• Independent Cell Culture Suites
• State-of-the-Art Testing Laboratories – with a full
array of testing capabilities
• cGMP Compliant Warehousing – for raw materials
and formulated bulk product
LuinaBio recommends the use of disposable
product contact equipment to reduce cleaning
validation requirements and reduce product
changeover costs.
It’s all about your product
LuinaBio has close to 20 years track record in successful technology transfer and
manufacture of biopharmaceutical products. Today we offer the experience, knowledge,
and resources to satisfy client’s requirements for reliable, cost-effective and high-quality
biopharmaceutical contract manufacturing services.
Our offerings include analytical and regulatory services to rapidly move through technical
transfer to successful manufacturing of your product. Our in-house testing laboratories have
a comprehensive array of testing capabilities, computer tracking, control and GMP compliant
warehousing for raw materials and formulated bulk product.
Strategic location
LuinaBio is located in the key biotech hub of Brisbane, Queensland Australia. Brisbane
provides excellent access to all major international ports. LuinaBio has developed effective
global freight processes for moving clinical trial material and perishable products quickly and
securely on behalf of clients.
LuinaBio licenses and
code compliance
LuinaBio is licensed by the Australian Therapeutic goods
Administration (TGA). Our open licence allows the manufacture
of active pharmaceutical ingredients (API) from biologic sources
or synthesis, and as such not limited to only clinical trial API
material. We are further licensed to review, label and release of
drug product for clinical supply.
The LuinaBio facility follows the international GMP
guidelines as setout into the (PIC/S) “Guide to Good
Manufacturing Practice for Medicinal Products Part II
(PIC/S 009-8). Australia is a founding member state of the
Pharmaceutical Inspection Co-operation Scheme resulting in the
guidelines being adopted by the TGA. As such our TGA licence
is recognized by other PIC/S member countries.
LuinaBio also carries a license from the Office of the Gene
technology Regulator (OGTR) allowing us to manufacture
recombinant proteins using genetically modified organisms.
LuinaBio welcomes inspections by client companies,
organisations and their consultants.
8 key reasons for choosing LuinaBio
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Proven Track Record
We have worked successfully with small, mid tier and large pharmaceutical
companies across all phases of clinical development. LuinaBio has
developed on going relationships with many clients.
Impeccable Inspection History
To date we have been inspected and audited by the TGA, APVMA, health,
safety and environmental agencies including the OGTR and AQIS and by our
customers and their consultants. LuinaBio has never received a critical
observation in the company’s history.
Strong regulatory support
LuinaBio delivers comprehensive reporting and documentation for process
and method development. Our quality system generates all necessary GMP
documents which are in compliance with applicable regulatory guidelines.
Commercial Sensitivity and IP
LuinaBio values the importance of protecting IP for the client. All project and
confidential information is handled with care and intellectual property contractual
arrangements typically ensure our customers own all results and IP generated.
Flexibility
We understand time to clinic is a critical success factor for biotech companies.
LuinaBio is structured to be responsive to our client needs and offers
flexibility that larger CMO’s cannot.
Effective communications
LuinaBioproject management is tasked with keeping the project on track
and communicating project progress regularly with clients. Regular meetings are
conducted by the project management team at the convenience of our clients.
Our team
Our experienced team of scientists deliver our clients products and project work
on time and on budget. All our highly qualified team has substantial experience
and knowledge in a broad range of bioprocess unit operations as well as
aqueous chemistry, production of cellular products, vaccines, recombinant
proteins, carbohydrates, other biomolecules and bio-conjugates.
Cost effectiveness
LuinaBio understands the need to control costs in early phase clinical
development. We have developed a cost efficiency strategy that enables
us to offer highly cost effective services to support our clients through their
development challenges.
Your key to early phase manufacturing
Our services provide cost effective manufacturing of your GMP clinical trial material. We offer
rapid technology transfer, scale-up development and manufacturing of microbial cell-derived
proteins at up to 500L scale for the preparation of active pharmaceutical ingredient (API)
products to world class standard to provide a key to your product development success.
Contact Information
Contact us via our web site, www.luinabio.com.au or email us at
[email protected] or call +61 7 3273 9170 to discuss our services.
Supporting you from Bench to Clinic to Market
2806 Ipswich Road, Darra, QLD 4076
www.luinabio.com.au
Phone: +61 (07) 3273 9176
Fax:
+61 (07) 3375 1168