Sterile

LuinaBio accommodates products in pre-clinical scale development, as well as more substantial clinical and niche commercial scale fill lots. In offering the latest in vial fill line technology and liquid and lyophilized scale-up process development services, we provide an all-inclusive service to clients which allows for alternate processing during this variable evaluation period.

The facility located in Brisbane features a series of modular clean room laboratories with ISO 8 fermentation suites and support areas. These ISO Class 8 manufacturing rooms feature microbial fermentation performed under cGMP conditions and feature:

  • Fermenters from 5L development reactors to 500L production vessels
  • Continuous tubular bowl centrifuges
  • Millipore ultrafiltration housings and associated equipment
  • Stokes stoppering shelf Lyophiliser (50L condenser capacity)
  • Stainless steel process tankage to 600:
  • Bioprocess chromatography system
  • Chromatography columns to 200L
  • 150L temperature and pressure synthesis reactor
  • Biohazard hoods
  • USP grade purified water system
  • Clean steam system
  • Clean steam Autoclave
  • Compressed air
  • Vacuum
  • Chilled glycol loop

Purification and final product isolation suites are ISO 7 cleanrooms operated under cGMP conditions and feature:

  • Fermentation (batch, fed batch and continuous)
  • Continuous centrifugation
  • Ultrafiltration
  • Membrane filtration
  • Reverse osmosis
  • Homogenisation
  • Lyophilisation
  • Hydrolysis
  • Synthetic reactions

These fermentation and isolation suites are supported by ISO 8 storage areas ranging from -80C to controlled ambient temperatures for raw materials, in-process and finished products.

What does our ISO designated mean for our clients? It means trust and consistency for your management, your shareholders and, more importantly, for your patients. LuinaBio operates to an internationally harmonized standard recognized by regulatory agencies to ensure a technically proficient manufacturing process, reliable quality and strategic advantages in the marketplace.

The TGA/APVMA licensed facilities operate to international cGMP standards and are capable of providing a comprehensive sterile manufacturing solution for clients both within Australia and internationally using our dedicated containment areas. A dedicated project manager can lead you through our available services and help you develop a plan that is efficient from a cost perspective and compliant with applicable regulations.