Biological Production Facilities

Discoveries in the laboratory represent a promise that can only be realized by their translation into clinical therapies. There is no adequate animal model for testing cancer therapies; novel therapies for humans require validation in humans. The processing and production of ‘patient-grade’ study agents is often the limiting step for academic institutions in moving their own research discoveries into the clinic.

The production of its own patient-grade study reagents is a central feature of the LICR Clinical Trials Model, in which all aspects of the early development of therapies from research discoveries are overseen by LICR.

LICR has two Biological Production Facilities (BPFs):

  • The BPF at the LICR Melbourne Branch/Austin Hospital in Melbourne, Australia was established in 1995, and produces patient-grade study reagents under the ‘current Good Manufacturing Practice’ (cGMP) code* as validated by the Therapeutic Goods Administration (TGA), Australia. The facility produces proteins using eukaryotic systems (human and animal cells) and vials reagents, such as small molecule inhibitors and peptides, for the LICR Clinical Trials Program.
  • The BPF located on the Cornell University campus in Ithaca (New York, USA) is part of the LICR/Cornell University Partnership, which was established in 2001. The BPF has established the core competencies required for the production of recombinant proteins using microbial expression systems (P. pastoris and E. coli). All process development is performed in the Bioprocess Development Laboratory, where every effort is made to duplicate the standard operating conditions in the BPF, from equipment to reagents. In this manner, a seamless transfer of technology to the BPF is ensured. The facility offers a GMP compliant setting where therapeutic recombinant proteins can be produced at high concentration and purity.

* The internationally-recognized cGMP code, which is set by the Food and Drug Administration (FDA) of the USA, is used by pharmaceutical and food manufacturers to ensure the safety of their products for humans. The cGMP code demands rigorous testing and validation of equipment and production process, as well as extensive documentation of all aspects of the starting materials. Operating under the cGMP code ensures that a facility produces patient-grade material, guaranteeing product safety and international acceptance. Without certified cGMP production, cancer reagents developed and produced by the LICR could not be administered to humans in early phase clinical trials without partnering with other commercial entities.