from bench to clinic to market - luina...

2806 Ipswich Road, Darra, QLD 4076 | T: +61 (07) 3273 9176 | F: +61 (07) 3375 1168

From Bench to Clinic to Market


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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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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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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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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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


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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Contract Manufacturing


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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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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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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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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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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Layout

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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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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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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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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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• 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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Warehousing and distribution


– 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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• 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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• 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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• 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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http://www.abf-pharma.com/


Thank youMax Rossetto

Head, Business Development

E: [email protected]

T: +61 400 987 334

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From Bench to Clinic to Market

from bench to clinic to market - luina...

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