Health and life sciences

Agility and innovation make Australia’s Linear a top clinical trials host

There was a time when Jayden Rogers had to explain to potential clients where Australia was and why they should conduct clinical trials here. Today, Australia is known as one of the best places in the world for clinical trials. This is in part due to the high-quality work undertaken by Rogers’ company, Linear Clinical Research.

Linear is an Australian not-for-profit organisation offering Phase I to Phase III clinical trials. To date, Linear has carried out over 420 studies in 20 therapeutic areas. It has worked with more than 300 sponsors from 18 countries. During the pandemic, the company saw record patient enrolments. It undertook over a dozen trials for COVID-19 therapeutics, two of which are now approved.

‘Australia has a well-deserved reputation as a world leader in clinical trials,’ says Rogers, Linear’s CEO. ‘We have a high-quality, advanced healthcare system, brilliant scientists and clinicians, and excellent R&D. Our streamlined regulatory approval process and generous research incentives also support international companies to conduct trials here.’

Tech innovation supports world-class trials

Founded in 2010, Linear has 2 state-of-the-art facilities in Western Australia. One of these is in the QEII Medical Centre, the largest medical precinct in the Southern Hemisphere.

Linear has a strong focus on Phase I healthy volunteer and Phase I cancer trials. The company has more than 100 early-phase cancer trials in its portfolio. It has one of the most active cancer trials team in the Asia-Pacific region.

Later in 2023, Linear will open a dedicated clinical trial private hospital for early-phase cancer trials. This will be the only one of its kind in Australia and it will triple Linear’s existing capacity.

Innovation has also played a part in Linear’s success. In 2017, the company was the first in Australia to install the eSource platform to capture data at the point of entry. It has also invested in telemetry and technology to monitor vital signs remotely. This investment in technology came to the fore during the pandemic.

‘Because we had electronic systems in place, we were able to switch to remote monitoring in just 7 days,’ says Rogers. ‘Our clinicians in Australia and clients in the US, Europe and China could view trial data in real time. It’s a collaborative way to run clinical trials.’

Clinical trials during COVID-19

Finding clinical trial participants during the pandemic was not an issue. In Western Australia, there is strong reach into many patient groups which are often consolidated into a small number of hospitals. This supports strong patient recruitment for clinical trials.

Linear also has over 40,000 healthy volunteer participants in its database. Australia’s multicultural population – 29% of citizens are born overseas – ensures a diverse patient cohort for clinical trials.

‘We delivered record enrolments for our cancer trials,’ says Rogers. ‘These patients would not have received treatment in other facilities. And we’re seeing amazing response rates. Up to 75% of patients observe some form of response with a small number experiencing complete responses (full remission) as a result of new therapeutics. It’s lifechanging.’

Linear also deployed its capabilities to support COVID-19 vaccine and therapeutic trials. The company worked with Chinese biotech Clover to undertake Phase I clinical trials for a vaccine candidate. It had the trial up and running in two weeks following ethics submission. The Phase I trial recruited 140 volunteers as a single site. This enabled a subsequent global Phase II/III trial that went on to demonstrate successful protection against COVID-19.

‘The Clover vaccine is now among the group of vaccines used in China,’ says Rogers. ‘It was thrilling to play a role in its development.’

Australia’s accelerated trial approval process

Linear undertook more than a dozen COVID-19 trials and prophylactic studies across a range of therapeutic modalities from 2020–2022. One of these was with Stanford University to trial an antibody to prevent COVID-19.

‘We worked around the clock with the Stanford researchers to help design the protocol,’ says Rogers. ‘Then we obtained ethics committee approval within 15 days, recruited patients and had the trial running within 20 days. It was the quickest clinical trial Linear has ever done. It is probably one of the quickest clinical trials in history, from the point of engagement to clinical execution and the delivery of data.’

Linear works with Bellberry, an organisation providing scientific and ethical review of human research projects. During the pandemic, Bellberry had an accelerated approval process for COVID-19 therapeutics and vaccines.

‘Australia’s pragmatic regulatory environment is one of our key strengths,’ says Rogers. ‘The Therapeutic Goods Administration delegates trial reviews to human-research ethics committees like Bellberry. This speeds approval times so clinical trials can be set up quickly but safely.’

Austrade paves entry into China

Almost all of Linear’s clients are international pharmaceutical or biotech firms. Most of them are from the US, followed by China and the EU. Rogers says Austrade was instrumental in helping Linear enter the Chinese market in 2017.

‘We’ve had tremendous support from Austrade over years,’ says Rogers. ‘The on-the-ground support in China was an important aspect of our growth in that market. Their staff went above and beyond. I would happily recommend Austrade to any business wanting to expand their overseas markets.’

Keeping innovation on the agenda

The past few years have seen major changes in therapeutics and approaches to clinical trials.

‘We’re seeing new molecules being tested, including bi-specific antibodies and drugs that target certain mutations based on genomics,’ say Rogers. ‘COVID-19 saw a shift to new treatments for infectious diseases and respiratory viruses. We’re seeing more targeted therapeutics, particularly mRNA therapeutics and cell therapies.

‘The world made a vaccine for COVID-19 in 12 months, thanks to research, industry and government working together,’ says Rogers. ‘At Linear, we want to keep pushing the innovation agenda. It’s the only way we can keep creating drugs that save lives.’

Read more about why Australia is a go-to destination for clinical trials.

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Contact an Austrade Investment Specialist in your region for more information about conducting clinical trials in Australia.

Published: 30 March 2023

Australian bovine tissue keeps hearts beating worldwide

Since 2015, tens of thousands of Australians have benefited from Edwards Lifesciences’ transcatheter aortic heart valve device. These lifechanging devices are made from Australian bovine tissue. Australian cows – raised in clean, green environments and famed for their health – provide the high-quality tissue needed to produce these devices. 

‘We have sourced bovine tissue from Australia for almost 20 years,’ says Polo Guilbert-Wright, Government Affairs Senior Director at Edwards Lifesciences Australia. ‘We look for tissue that is consistently healthy, and our Australian suppliers always deliver. We also have full traceability across the supply chain.’ 

Sourcing lifesaving bovine tissue from Australia  

Edwards Lifesciences designs, develops and manufactures products for structural heart disease and critical care monitoring. The California-based company set up a subsidiary in Australia in 2001 and now employs over 100 people across 5 states.  

A critical component of Edwards Lifesciences’ heart valves is bovine pericardium tissue (the sac that surrounds a cow’s heart). This thin but durable tissue is a key part of the transcatheter aortic valve implantation (TAVI) used to treat aortic stenosis. 

Edwards Lifesciences sources this tissue from multiple suppliers in the US and Australia. Australia provides more than half of the company’s tissue supply. It sources tissue from multiple suppliers in Queensland. Guilbert-Wright says Australian bovine tissue is outstanding. 

‘We need to make sure the thickness and performance of the “leaflets” (the thin flaps of tissue used to make heart valves) are consistent,’ he explains. ‘Otherwise, they will affect how blood flows through the heart. We find the tissue coming out of Australia is consistent and of a high quality.’ 

Fully traceable from paddock to patient 

Edwards Lifesciences’ Australian suppliers extract, clean and pack the tissue into Eskies filled with wet ice. These Eskies are transported to the US and Singapore where the tissue is manufactured into heart valves. This process must be completed in 96 hours. 

‘Our Australian suppliers document the entire process,’ says Guilbert-Wright. ‘We can trace the tissue back to a group or lot of cattle and follow it until it arrives. It ensures full accountability across the supply chain.’ 

IFAM flies lifesaving tissue to the US 

The closure of international borders due to COVID-19 threatened to cut off a critical supply chain. Overnight, there was no way to transport the tissue from Australia to the US. 

Edwards Lifesciences immediately turned to Austrade for help. Within a short period of time, the agency obtained the permissions that enabled the company to access the International Freight Assistance Mechanism (IFAM). IFAM was a temporary, targeted, emergency support measure put in place by the previous Australian Government. It kept global air links open in response to the effects of the pandemic. 

Edwards Lifesciences used IFAM to airfreight bovine tissue from April 2020 until June 2022. The service ensured the tissue reached the California production facility before its 96-hour expiry period. The company imported more than 400,000 batches of tissue over that time. 

‘The IFAM flights helped keep the supply chain of our tissue between Australia and the US open,’ says Edwards Lifesciences Managing Director for ANZ, Pat Williams. 

‘We have been able to continue sending bovine tissue from Brisbane to Irvine, where they are manufactured into life-saving heart valves and sent to patients all over the world.’ 

Austrade has supported Edwards Lifesciences for several years. In addition to IFAM, the agency has provided information on Australia’s regulatory environment and its clinical trials infrastructure. It has also introduced the company to various arms of government. 

Trialling next-generation products in Australia 

Edwards Lifesciences also undertakes clinical trials in Australia. The company works with a number of Australian hospitals that contribute to global clinical trials. It also works with tertiary hospitals that recruit and treat patients. 

Guilbert-Wright says there are many reasons why Australia is a great place for clinical trials. 

‘The quality of clinical outcomes is outstanding,’ he says. ‘The infrastructure – in terms of the hospitals and their ability to recruit and treat patients – is impressive.  

‘The Australian clinical fraternity is first-rate. The clinicians we partner with are on the podium at all the global cardiac symposia. We are privileged to partner with them. 

‘It’s also easy to set up clinical trials here,’ he adds. ‘That’s a real comparative advantage for Australia as compared to other jurisdictions.’ 

Australia also has a globally recognised regulatory system. Data from clinical trials conducted in Australia is accepted by overseas regulatory agencies. 

Find out why Australia is a go-to destination for clinical trials. 

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Contact Austrade for more information about investing in Australia’s health and life sciences industry. 

Published: 14 March 2023

Moderna selects Melbourne for Australia’s first large-scale mRNA vaccine facility

COVID-19 mRNA vaccine pioneer, Moderna, is building a new hub for biotech research and manufacturing in Australia.

The facility in Melbourne’s life-sciences precinct will have the capacity to manufacture up to 100 million vaccine doses per year for respiratory viruses such as COVID, influenza and respiratory syncytial virus (RSV).

In addition, Moderna will establish a new, regional mRNA research centre in Melbourne. This will become a hub for research into respiratory viruses and tropical diseases across the Asia-Pacific.

‘Australia’s science and R&D ecosystem is world-class, and this is one of the reasons we decided to build our first commercial-scale facility in Australia,’ says Michael Azrak, General Manager, Moderna Australia & New Zealand.

‘We want to support a thriving biotech community where the best and brightest have the opportunity to collaborate and contribute to advancing mRNA science,’ he adds.

New biotech facility will create hundreds of jobs

Massachusetts-based Moderna made global headlines in 2021 with its revolutionary mRNA vaccine. mRNA vaccines were critical for combating the COVID-19 pandemic, reducing hospitalisations and saving millions of lives globally.

The success of its COVID vaccine has meant rapid growth for Moderna. In August 2022, the company announced that – in partnership with the Australian and Victorian governments – Melbourne would be the home of a huge, new investment in life-sciences research and manufacturing.

Moderna’s facility will create hundreds of construction jobs, and ongoing roles in manufacturing and research.

This year, Moderna will also establish an Australian fellowship program to advance mRNA science. The program will include facilitating an immersive industry learning experience for bio-pharma innovators, who will be able to travel to Moderna’s Boston headquarters for training and knowledge-sharing activities.

The annual program will offer two fellowships worth A$250,000 each per year.

A top venue for clinical trials in the Asia-Pacific

One significant attraction for Moderna is Australia’s capabilities in early clinical development and clinical trials.

‘Australia is a great place to do clinical trials because Australian clinicians know how to run trials well,’ says Azrak. ‘Australia provides good infrastructure and facilities, regulatory support, medical expertise and a diverse population for trial recruitment.’

Australia is currently a registered trial country for five of Moderna’s ongoing clinical trial studies. These trials include over 40 study sites. They also include the company’s Phase 2 study into a personalised cancer vaccine targeting melanoma.

Azrak reports that Moderna finds it comparatively easy to establish trials networks in Australia and recruit patients.

‘We can collect trial data and get results back to the global study team in a timely way,’ he says. ‘This is partly due to local expertise. Australia is home to high standard contract research organisations (CROs), universities and teaching hospitals that are well-versed with global requirements.’

Government support for advanced bio-pharma science

Moderna leaders say Australia has multiple advantages for ambitious biotech companies. First, the Commonwealth and State Governments are highly supportive.

‘The Victorian Government is very forward thinking in terms of fostering Melbourne’s biotech industry,’ says Azrak. ‘They helped us address regulatory barriers and accelerated our construction plans. Victoria wants to create a local biotech industry that is on par with Boston and Oxford.’

Second, Australia’s A$20 billion Medical Research Future Fund (MRFF) supports long-term investment in health and medical research. It channels funding towards innovation and science research in medicine and health care.

‘There are tax incentives for research and development, and the Government’s MRFF is also valuable at providing capital investment,’ says Azrak.

Biomedical research hubs a magnet for investment

One other draw card is local expertise. This includes the emergence of biopharma hubs around major hospitals and universities.

‘Australia is a strong venue for active medical research,’ Azrak says. ‘Australia has world-class institutes, great incubator hubs and excellent teaching hospitals. These facilities are often within walking distance of each other. This helps our biotech experts collaborate with each other.’

He cites the Monash Technology Precinct in Melbourne. This precinct is home to Monash University, the Australian Synchrotron and Commonwealth Scientific and Industry Research Organisation (CSIRO) facilities.

Moderna will contribute to this life-sciences ecocentre with a new research centre, which will spearhead research into respiratory diseases and tropical medicine.

‘Our new Melbourne centre will be a hub for the Asia-Pacific,’ says Azrak. ‘It will link together academic work that’s being done in research institutes across the region – and look at how mRNA treatments can help combat diseases that need medical solutions.’

Globally respected standards

Azrak predicts that Australia has a bright future in biomedical research. Prospects rest on the fact that Australian medical research has an excellent reputation.

‘We have very high standards of care here in Australia – and universal access,’ says Azrak. ‘Australia’s regime for health regulation is so well regarded that it’s used as a reference point in many other countries.

‘Our chief regulator – the TGA [Therapeutic Goods Administration] – is world-class. It applied an innovative lens to new medicines approval during the pandemic. And the TGA’s assessments carry weight across the Asia-Pacific region.’

Support from Austrade and state government agencies

Moderna’s new manufacturing facility is scheduled for completion in 2024. It will be part of an ongoing, 10-year partnership between Moderna, the Victorian Government and the federal Australian Government.

‘Austrade has always been open and supportive – especially during the early stages of discussions,’ says Azrak. ‘The federal and Victorian State governments and mRNA Victoria were also great champions of promoting Australia as a destination for investment.’

‘We think Australia has come on in leaps and bounds in terms of skills and opportunities in the biopharma sector,’ he adds. ‘The focus on life sciences has really expanded in Australia over recent years. Coming here and building a manufacturing facility requires a great skills base – and that’s what we get in Australia.’

Go further, faster with Austrade

Contact an Austrade Investment Specialist in your region for more information about investment opportunities in Australia.

Published: 15 February 2023

Stryker taps into Australian medtech innovation with new R&D Lab

US medtech giant Stryker has opened its first R&D Lab in Australia. Based in Brisbane, Queensland, the Lab will focus on digital health, robotics, clinical software and advanced manufacturing.

The investment will see Stryker work with some of Australia’s leading universities and medical research institutes.

‘Stryker touches the lives of more than 100 million patients globally each year,’ says Stryker Chair and CEO Kevin Lobo. ‘We have a strong heritage of innovation. The possibilities of what will be developed in this lab are inspiring.’

Australia: a leading destination for health innovation

Dr Homer Stryker, an orthopaedic surgeon, founded Stryker in 1941. Today, the company makes medical and surgical equipment, neurotechnology, orthopaedics and spinal products.

The company arrived in Australia in 1984. It now has over 800 employees in Sydney, Melbourne, Brisbane, Perth and Adelaide.

The genesis of the R&D Lab is the Just-In-Time project. This was a 5-year collaborative research project between Stryker and the following Australian organisations:

• Innovative Manufacturing Cooperative Research Centre (IMCRC)
• RMIT University
• University of Melbourne
• University of Sydney
• University of Technology Sydney
• St Vincent’s Hospital Melbourne.

The project combined 3D printing, robotic surgery and advanced manufacturing to create just-in-time tailored implants for people with bone cancer. It transformed the development and delivery of implants for musculoskeletal tumour patients.

Brisbane’s medtech hub

Stryker’s new R&D Lab will be based in the Herston Health Precinct in Brisbane. The precinct is home to over 30 health facilities. It is also home to around 13,000 clinical and non-clinical scientists, researchers, students and other health workers.

‘This medtech ecosystem allows the R&D Lab’s researchers and engineers to collaborate with clinicians,’ says Maurice Ben-Mayor, President of Stryker South Pacific. ‘We can understand their current and future needs — all at the site of care.’

The R&D Lab builds on existing partnerships in Australia. This includes partnerships with clinicians, researchers, universities, healthcare providers and government.

‘These partnerships have demonstrated the power of collaboration,’ says Ben-Mayor. ‘The R&D Lab is poised to have a profound impact on the future of healthcare [and] we’ve expanded our focus to include digital health, robotics, clinical software applications and advanced manufacturing.’

Investment assistance from the Queensland Government

The Queensland Government provided a multimillion-dollar grant to support the R&D Lab’s establishment.

‘This new R&D base is testament to the world-leading scientific research talent and medical infrastructure we have here for global and local companies,’ says Yvette D’Ath, Queensland Minister for Health and Ambulance Services.

‘The new Stryker R&D Lab will mean Queensland researchers and patients will have access to the latest products and technologies.’

Austrade also supported Stryker’s investment. Advisers gave strategic input into its business case. They also introduced Stryker to state and federal government representatives.

Medical research with Australian universities

The new Lab includes academic partnerships: Stryker, Queensland University of Technology (QUT), The University of Queensland (UQ), Metro North Hospital and Health Service (MNHHS) and Queensland Health have entered a Master Research Agreement.

Projects include looking at how artificial intelligence and machine learning can improve healthcare applications. The aim is to develop new data-driven approaches to clinical problem solving. These could deliver faster, deeper insights to support real-time clinical decision-making. 

‘The establishment of the R&D Lab allows us to meaningfully collaborate with clinicians, researchers, scientists, and institutions from across Australia,’ says Lobo. ‘It allows us to transfer our leading research into real-world patient outcomes.

Aussie unis fired up by robotics prospects

University officials believe the tie-up will boost research into robotics.

‘The partnership with Stryker will provide another critical pathway for UQ research,’ says UQ Vice Chancellor Professor Deborah Terry. ‘We believe the collaboration between industry, academia and government will help drive community impact in Queensland, in Australia and around the world.’

QUT says its focus will be on digital health and robotics technologies. It foresees that these areas will take centre stage in medical innovation over the coming decades.

‘QUT has long been an international leader in robotics and biomedical engineering,’ says QUT Vice-Chancellor Professor Margaret Sheil. ‘We look forward to seeing how our researchers will work together with Stryker as a partner in this facility.’

Contributing to Australia’s COVID-19 response

Stryker has already experienced the agile capabilities of the Australian healthcare industry. In early 2020, the company harnessed the adaptability and innovation of Australia’s healthcare experts to make a major contribution to the country’s COVID-19 response.

Stryker worked with the Advanced Manufacturing Growth Centre to develop an Emergency Relief Bed. Designed to accommodate patients in respiratory distress, the bed offered 30-degree head elevation, low height and an attached intravenous pole.

In just 6 days, Stryker partnered with 4 Australian manufacturers to adapt the bed’s design, build the prototype and start production. The Emergency Relief Bed presented a low-cost, scalable solution for the Australian Government. It has also been used to support Australia’s Pacific neighbours throughout the COVID-19 pandemic.

Published: 17 October 2022

Sojitz directs investment into Australian healthcare, renewables, green hydrogen and recycling

Sojitz is driven by solutions that benefit both the company and society.

In this case study, TATS KATO, Head of Project Origination at Sojitz Australia, details the Japanese company’s new ambitions in healthcare, renewables, green hydrogen and recycling.

Providing solutions to social problems

Sojitz is motivated by a simple motto: new way, new value. 

The Japanese corporation comprises 400 subsidiaries and affiliates around the world. It engages in a range of businesses globally, including manufacturing, selling, importing and exporting products and materials.

Sojitz pursues growth by providing solutions to social problems. Solutions-based initiatives in investment and trade, manufacturing, service provision and project management have become areas of strength for the global company.

Strength in the circular economy & ESG investments

In Australia, Sojitz is pivoting its investment strategy from legacy sectors to the circular economy.

Sojitz sees the shift as an exciting growth opportunity that can be applied to future-focused businesses in a wide range of fields.

TATS KATO, Head of Project Origination at Sojitz Australia, outlines 4 areas of interest:

• Healthcare
• Renewables
• Green hydrogen
• Recycling

A passion for healthcare

Several factors make Australia a strong contender for healthcare investment, according to TATS. These include:

• robust economic and population growth
• a well-established healthcare system
• public–private partnership (PPP) regulations that are supportive of infrastructure development.

Sojitz is driven by these factors and a passion for healthcare. The company made a major investment in Victoria’s New Footscray Hospital (NFH) PPP Project in March 2021.

NFH will provide high-quality facilities to improve health outcomes. There will be capacity to treat an extra 15,000 people every year. It will also drastically reduce wait times across the emergency department, elective surgery and outpatient clinic services.

The hospital will be built using more than 90% local materials, services and equipment. The project will employ more than 2,000 people at peak construction.

Sojitz has also invested in Qualitas Medical Limited. This company expands primary care services to strengthen preventive medicine. This reduces expensive medical treatment costs in acute care.

The future is renewable

‘Global warming has emerged as an issue of major importance,’ says TATS. ‘This has accelerated the global trend towards carbon neutrality.

‘Under these circumstances, it is necessary to transition from the simple use and supply of energy to new ways of using and supplying green energy.’

Sojitz sees Australia as a high-growth market for renewables. Its vast land area and abundant sunshine are ideal for solar energy projects.

In June 2021, the company reached the financial close of the 204MW Edenvale Solar Park in Queensland. It is one of the largest solar projects by a Japanese company in Australia.

This project will create more than 400 jobs during its construction phase. Once operating, it will provide a stable supply of renewable energy, meaningfully contributing to Australia’s decarbonisation efforts.

Sojitz’s global target is to reduce its stakes in thermal coal projects more than half by 2025 and to zero by 2030. But TATS makes clear that during the transition period, coal will still play an important role.

‘Sojitz will keep our current coal business for stable supply to our end users,’ he says. ‘These will continue to contribute to regional communities through our operating mines in Queensland.’

A leading destination for green hydrogen projects

Australia offers a clear policy framework for green hydrogen initiatives, and relatively low hydrogen production costs compared with other developed nations.

TATS adds that federal and state-level grants and other forms of support for the hydrogen sector makes Australia an even more attractive investment option. In January 2022, the Australian Government announced the A$150 million Australian Clean Hydrogen Trade Program. The program supports Australian-based hydrogen supply chain projects that secure overseas public or private sector investment.

The first round of the Program will focus on the export of clean hydrogen to Japan under the Japan-Australia Partnership on Decarbonisation through Technology. Under the Partnership, announced in June 2021, the two countries will support initiatives that help drive the transition to net zero emissions.

Sojitz will work with Queensland’s CS Energy and Nippon Engineering Consultants on a pioneering green hydrogen project. The 3-year demonstration sees Sojitz transport Queensland-produced renewable hydrogen to the Republic of Palau.

Sojitz intends to roll out the initiative to other Pacific nations. It hopes to popularise hydrogen use in place of carbon-intensive diesel fuel use on islands.

Looking for recycling and waste recovery opportunities

Sojitz is actively looking for investment opportunities in the Australian recycling and energy recovery markets.

‘Recycling is a hot topic in Australia now,’ says TATS. ‘Our investments in this area will contribute to achieving several goals set by the Australian Government. These include enhancing the resource recovery rate and decreasing landfill.’

Sojitz Australia is also looking to contribute to circular economy growth areas.

‘Our new initiatives must add value to both Sojitz and society. We call it a “Value Creation Model”,’ says TATS. ‘Creating new “shared value” is in our company’s DNA.’

Published: 9 February 2022

Developing technologies to support the next generation of mRNA-based therapies

Australian biologics manufacturer BioCina has plans to further develop its state-of-the-art facility to enable it to make the next generation of mRNA vaccines and other mRNA-based therapies possible.

Backed by Australian Government financial support, BioCina is partnering with the University of Adelaide and US-based Cytiva to speed RNA-based product development and make them more stable. This will accelerate progress to clinical trials for future vaccines and other diseases, including cancer.

‘There is a large unmet demand for high-quality manufacturing in the microbial space,’ says Ian Wisenberg, BioCina’s CEO. ‘With the support of our investors, the Bridgewest Group of Companies, we aim to step up to meet that need.’

Microbial platform-based manufacturing

BioCina is a full-service contract development and manufacturing organisation (CDMO). It specialises in process development and GMP manufacture of recombinant biological therapeutic products.

BioCina uses microbial cells to manufacture complex biological molecules, such as proteins and poly nucleic acids. These molecules typically cannot be made using conventional chemical synthetic methods. The biological molecules are made by fermenting then purifying from microbial cells (mainly E. coli). These products can be used in clinical trials or for commercial purposes.

‘Using microbial cells in manufacturing is cost-effective,’ says Wisenberg. ‘Manufacturing can be done at very large scale to make products at a low-cost point.’

BioCina manufactures a wide range of products for clients. They include recombinant whole-cell vaccines, recombinant proteins such as antibody fragments, and nucleases. It also makes cGMP-grade plasmid DNA and will soon be able to manufacture RNA products.

A high-quality, cost-effective location for manufacturing

Wisenberg says Australia’s clinical trials and manufacturing expertise make the country a high-quality, cost-effective location to develop and manufacture new treatments.

‘Australia has a highly regarded clinical trials network that is known for rapid approval and completion of Phase I clinical studies,’ he says. ‘It makes sense to manufacture products close to the clinical trial site, and vice versa. It is much more cost-effective and efficient for the drug sponsor.’

In addition to simplifying the supply chain, Australia offers grants and incentives to conduct research and development here. The R&D Tax Incentive covers all R&D work including GMP manufacture and clinical trials. Australia also has a highly developed biomedical ecosystem offering opportunities to collaborate with world-leading experts.

A full-service manufacturing facility

BioCina’s Adelaide facility has a well-established history in the microbial manufacturing space. It was most recently owned and operated by Pfizer, and Hospira before that. The facility was upgraded in 2016 at a cost of $25 million and is now one of the premier facilities of its kind in the Oceania region. The facility is licensed for GMP manufacture by Australia’s Therapeutic Goods Administration and has been inspected by the US FDA.

‘It has manufactured a commercial product that is being marketed and sold in the US, Europe and Canada by Pfizer,’ says Wisenberg.

The facility offers full clinical supply services from early-phase clinical trials to commercialisation to biopharmaceutical customers. It is the only CDMO in the region with the capability and capacity to manufacture plasmid DNA in a GLP and GMP environment.

‘We are just eight months into this new facility and have already increased our headcount by over 25%,’ says Wisenberg. ‘We are looking to expand our footprint both locally and internationally.’

Manufacturing the next generation of mRNA vaccines

BioCina recently received a A$3 million grant through the Cooperative Research Centres Projects Grants scheme. The grant will fund work to address the post-pandemic demand for new mRNA products.

‘The market is looking for a more stable mRNA product that can be stored at temperatures of 2 to 8 degrees,’ says Wisenberg. ‘The market will also prioritise LNP formulations that optimise the delivery and therapeutic efficiency of the mRNA cargo. There will also be increasing demand for next-generation RNA constructs such as circular RNA that circumvent limitations of conventional first-generation mRNA products.’

BioCina’s partners in the project are the University of Adelaide and Cytiva. Researchers at the university will address the design and manufacture of lipid nanoparticles. They will also look at improving formulation to increase product stability. Cytiva will supply the mRNA manufacturing equipment at R&D and GMP scales.

‘The technological advancement developed by our research partners will allow mRNA drugs to be targeted to specific tissues,’ says Wisenberg. ‘The final product will also be stable at higher temperatures, making it easier to store and transport.

‘Together, we will establish the critical infrastructure to translate Australian research in mRNA, and other RNA-based therapeutic modalities, to the clinic.’

BioCina and its partners will also develop mRNA-based therapies to treat other disease types such as cystic fibrosis, heart disease, rare genetic conditions, and some cancers.

Published: 1 June 2022