Announces new bio-manufacturing GMP and development facilities.
Luina Bio, one of Australia’s most experienced biopharmaceutical contract development and manufacturing (CDMO) organizations, is expanding to meet the increasing demand in the microbiome and recombinant biopharma markets.
The first stage of the expansion will see Luina open an additional small scale (30L) GMP manufacturing suite in late 2020, broadening he company’s service offering for new clinical projects that need small scale GMP facilities. This facility will be available to customers in Q3 2020.
This will be followed by the opening of four additional development laboratories in late 2020, allowing Luina to take customer projects from the earliest development stage to a volume of 500L. This opening formally introduces the company’s systems approach to facility design and utilization, known as the Luina Flexible Manufacturing Platform (Luina FMP). The Luina FMP environment is designed to deliver the speed and technical excellence necessary to handle the development of technically advanced microbiome & recombinant protein projects. It capitalizes on years of experience Luina Bio has growing bacteria initially thought to be unable to be grown at useful quantities for customers.
Les Tillack, CEO of Luina Bio commented, “This new small-scale suite will allow us to respond to those customers that need a smaller active dose for their initial clinical development, while also giving them access to Luina’s proprietary FMP facility flexibility. Luina FMP was developed from over three decades of contract manufacturing experience, knowledge and expertise culminating in a unique manufacturing approach that advantages Luina Bio’s customers.”
New Large-Scale GMP Facility
Currently in planning, the next stage will see Luina develop a 10,000m2 late phase clinical and commercial production facility for commissioning in late 2021.
The new facility will have up to five production lines in parallel, ensuring that multiple-strain live biotherapeutics projects have compressed production times. Luina’s largest reactor (2,000L) will allow it to deliver live biotherapeutics volumes compatible with the commercial needs of those companies that have single-strain projects.
The facility will also boast new technologies to decrease the downstream processing time of live biotherapeutics and bacterial recombinant biotherapy projects dramatically.
“We aim to deliver the world’s most technologically advanced live biotherapeutics manufacturing plant so that our customers can be safe in the knowledge that their projects will be delivered on specification and on budget. This quality-centric approach will start at the earliest possible development stage and continue throughout the life of the project,” said Tillack.
The new facility further expands Luina’s capability for expanded capacity for bacterial and yeast recombinant projects including vaccine manufacturing, particularly in light of COVID-19 vaccine manufacturing demand.
Tillack further commented, “Luina Bio already possesses the intricate cGMP capabilities needed to manufacture a COVID-19 vaccine and has the potential to cut down the time associated with this type of infrastructure and advanced processes development by a number of years helping Australia’s preparedness for COVID and other potential pandemic challenges.
Luina Bio’s location allows it to use Australia’s scientific workforce for this expansion. Luina continues to work with the Queensland government grant programs enabling new process engineering, systems capability and jobs. The company will also be recruiting additional technical and scientific staff further supporting and growing the biotechnology industry in Queensland potentially up to a further 300 staff.