Australian biopharmaceutical contract development and manufacturing company Luina Bio has announced plans to expand its capacity to meet demand in the microbiome and recombinant biopharma markets.
The company said the first stage of the expansion will see it open additional small scale (30L) GMP manufacturing suite in late 2020. This will broaden its service offering for new clinical projects that need small scale GMP facilities. This facility will be available to customers in 2020.
Luina said this will be followed by the opening of four additional development laboratories in late 2020, allowing it to take customer projects from the earliest development stage to a volume of 500L.
According to CEO Les Tillack, “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 [Flexible Manufacturing Platform] 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.”
The company said the next stage will see it develop a 10,000 square metre 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 said its 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," said the company.
“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 Mr Tillack.
Mr Tillack added, “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."