1 September 2020
Highlights
- Small scale GMP manufacturing suites open in Q3 2020
- 500L tech transfer and process development site aim for open Q4 2020
- This precedes the next phase with Luina planning to commission a 10,000m2 late phase clinical and commercial production facility targeting late 2021
- New facilities capture more of the global value chain supporting technically advanced microbiome projects
- New expanded capacity for bacterial and yeast recombinant projects including vaccine manufacturing including COVID-19 candidates
Luina Bio, one of Australia’s most experienced biopharmaceutical contract development and manufacturing (CDMO) organisations, is pleased to announce 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 and has already generated interest from Luina Bio clients.
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.
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 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.”
