Australian CDMO announces new bio-manufacturing GMP and development facility expansion

Luina Bio, one of Australia’s most experienced biopharmaceutical contract development and manufacturing (CDMO) organisations, has announced several expansion plans to meet the increasing demand in the microbiome and recombinant biopharma markets.

The first stage of the expansion will see Luina open 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 utilisation, known as the Luina Flexible Manufacturing Platform (Luina FMPTM). The Luina FMPTM environment is designed to deliver the speed and technical excellence necessary to handle the development of technically advanced microbiome & recombinant protein projects. It capitalises on years of experience Luina Bio has growing bacteria initially thought to be unable to be grown at useful quantities for customers.

“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 FMPTM facility flexibility. Luina FMPTM 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,” Les Tillack, CEO of Luina Bio said.

Currently in planning, the next stage will see Luina develop a 10,000 sqm 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.

Luina Bio’s location allows it to use Australia’s high-quality 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.