from bench to clinic to market - luina...
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
From Bench to Clinic to Market
2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Who are we?
LuinaBio is one of Australia’s most experienced
biopharmaceutical CDMO’s.
We offer two types of services:
– GMP manufacture of:• Recombinant proteins & vaccines
• Synthetic molecules
– Warehousing and distribution of I.P. for clinical
studies
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
LuinaBio Experience
More than 20 years of CDMO experience
across all phases of clinical development– Bacterial & Yeast Fermentation
– Recombinant proteins
– Carbohydrates and carbohydrate conjugates
– Synthetic molecules
– Vaccines and immunotherapies
– DNA/Gene therapies
– Phase I, II, III warehousing and distribution
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Track Record
LuinaBio provides services to global, multi-national and local clients. 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 sourced Semisynthetic 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.
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Global customers
LuinaBio has worked with clients from Asia, Europe, America & Australia.
– Our clients include biopharmaceutical developmentcompanies, research institutes, veterinary drugcompanies and Universities
– We routinely repeat manufacture to support ongoingproduct development
– LuinaBio has developed effective global freightprocesses for moving clinical trial material and otherperishable products quickly and securely on behalf ofclients.
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Cost comparison USA
Australia
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100 72 44
USA
Australia
Australia ( with R&DTax)
Currency conversion rate AUD1 = USD 0.9Study By Frost and Sullivan 2016
Cost comparison for a standardized early phase trial conducted in Australia and USA
The savings for process development and manufacturing are comparable
2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Why work with us?
• Expertise in biopharmaceutical production from
bacterial / yeast cell lines
• GMP material for:
– Pre-clinical
– Clinical Phase 1, 2 & 3
– Market
• Warehousing and distribution of I.P.
• Highly cost competitive
• Extremely flexible with fast access and turnaround times
• Access R&D tax credit (43.5% upfront govt. rebate)
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Contract Manufacturing
2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Microbial Fermentation
Luina Bio offers the following services in microbial fermentation for both bacterial and yeast strains:
– Master and working cell bank preparation, validation and storage
– Fermentation and subsequent downstream purification
– Downstream processing optimisation and development
– Up/downscale Fermentation
– Multiple feed strategies and media options
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Anaerobic Fermentation
LuinaBio is highly experienced in working with
strict anaerobic cultures:
– Anaerobic cell bank preparation and qualification
– Anaerobic fermentation up to 500L
– Anaerobic mid stream and downstream
processing
– Anaerobic lyophilisation of live cultures
– Anaerobic product packaging
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Vaccine Production
Luina Bio offers cGMP production of viral
vaccines– Dedicated manufacturing area for production of viral
vaccines
– Production of live or killed bacterial vaccines
– Specialty in formalin killing and removal
– Documentation
– Support services
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Process development
In addition LuinaBio offers the following
services to ensure success of your project– Process validation
– QC assay performance / development / validation
– GMP document preparation
– Regulatory advice
– CMC package development
– Product labelling
– Product distribution
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Facilities
LuinaBio's 1,200m2 facility is located in
Brisbane, Australia
– It comprises of a series of modular clean room
laboratories with ISO 8 fermentation suites and
support areas.
– Purification and final product isolation suites are ISO
7 clean rooms.
– The laboratory area is supported by a range of raw
material, in-process and finished product storage
areas ranging from -80°C to controlled ambient.
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Layout
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Processes & Equipment• Fermentation at 5l, 30l, 75l and 500l
scale
• Fed batch capabilities
• Cell recovery – discrete centrifugation
– continuous centrifugation
– ultrafiltration
• Microfluidics high pressure homogeniser for cell rupture
• Final product filtration
• Lyophilisation – bulk (up to 40l)
– vials
– stoppering
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Processes & Equipment• Chromatography
– AKTA 100 system (100ml/min)
– AKTA Biopilot (800ml/min)
– AKTA Bioprocess skid (2,000ml/min)
• Chromatography columns 2l to 200l
• 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
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Quality Assurance
LuinaBio invests heavily in QA
– We operate under and comply with the PIC/S GMP
code
– Audited and certified by the TGA
– Audited by clients including the
Pfizer and Zoetis global audit teams
– Audited to USFDA requirements
by independent consultants
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Facility Licenses
LuinaBio has the following operating licenses:
– TGA (Australian FDA equivalent) license for the manufacture of human therapeutic API's from biological and synthetic sources
– APVMA (Veterinary equivalent of the TGA) license for manufacture of sterile immunobiological products
– OGTR license for the production of products from genetically modified organisms
– DAF (formerly AQIS) facility license for import and use of biologic materials
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
• Packaging Room
• Dedicated grade D equipment wash room
• Dedicated Equipment Store Room
• Dedicated Fermentation Rooms
• Dedicated Purification Rooms
• All rooms are continuously monitored:
– temperature
– humidity
Manufacturing Rooms
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Warehousing and distribution
2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
– In addition to manufacturing API we can secondary
package, warehouse and distribute clinical trial
batches for use in Australia and New Zealand
– LuinaBio holds licenses for manufacturing and
storage both clinical stage and commercial API’s and
finished pharmaceutical goods
– LuinaBio can import API and finished products for
clinical trials and store them in Quarantine prior to
local ethics approvals to enable faster trial start up
Services
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
• Warehouse:
– Dedicated secure quarantine area
– Warehouse with temperature <27⁰C
– Walk in 2-8⁰C Cool Room
– -20⁰C Freezers
– -80⁰C Freezers
– 24/7 Automated monitoring of ambient conditions and
facilities
– Finished product warehouse for distribution to clinical
sites
Warehouse
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
• Labelling of clinical trial batches, including blinding
• Review and preparation of labels and ancillary labels complying with APVMA, TGA and MEDSAFE requirements
• Design and manufacture of investigators’ kits
• Labelling machine and printer
• Multilingual labelling (Collaboration with ABF)
• Re-labelling, over-labelling and shelf life extensions under cGMP
• Complete randomisation and blinding of products
• QP Release for Supply to Europe
Packaging
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
• Distribution in Australia and New Zealand through
network of high quality carriers
• Import/Export permits:
– API
– Finished products
– Relevant permits (DAF, Restricted Substances, Controlled
substances etc)
• Mutual qualification with ABF (www.abf-pharma.com)
allows for expedited import/export from/to EU/US
• Recall protocols established
Distribution
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2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168
Thank youMax Rossetto
Head, Business Development
T: +61 400 987 334
Supporting you
From Bench to Clinic to Market