The infrastructure enabling cell therapy access for Australian patients 

A powerful cellular immunotherapy developed by Professor Rajiv Khanna AO and his team at QIMR Berghofer and manufactured at Q-Gen Cell Therapeutics is saving lives.  

The therapy targets severe viral infections caused by common viruses such as Epstein-Barr Virus that can become life threatening in immunocompromised patients. What makes this treatment special is that it is made in Australia. The therapy is manufactured at Q-Gen Cell Therapeutics, a TGA-licensed cell manufacturing facility with over 20 years of experience, supported by Therapeutic Innovation Australia (TIA) through the National Collaborative Research Infrastructure Strategy (NCRIS) Program. 

As Dr Cathy Foley, former Chief Scientist, noted, NCRIS “has become an essential part of Australia’s industrial base”. Through NCRIS support, Q-Gen enables research developed in Australia to translate into clinical improvements for Australian patients. With its TGA manufacturing licence, Q-Gen provides the clean room facilities, and critical expertise needed for safe manufacture of novel therapeutics.  Whilst NCRIS is not the complete answer, she noted that without it, Australia’s ability to respond to technological challenges would be slower, weaker and more expensive. 

Kim Carr, a former Minister for Innovation, reflected that NCRIS has quietly become one of Australia’s most successful nation‑building investments, enabling world‑class research, supporting collaborations and partnerships, and helping tackle health challenges that affect Australian patients. 

The Ambitious Australia report (SERD) also reinforced that “access to high‑quality research infrastructure is critical.” It is this access that was crucial for Dr Khanna’s therapies to be made here for Australian patients.  

Although the therapy has not yet been approved by the TGA, it is being supplied under TGA’s Special Access Scheme (SAS). The SAS provides a pathway for registered health practitioners to access unapproved therapeutic goods for patients on a case-by-case basis when all other treatment options have been exhausted.  Of 71 patients treated under the TGA’s SAS, 46 have shown clinical benefit (Neller et al., 2024). 

Koby, from Perth, received the therapy at age eight after developing a life-threatening viral infection with only a 10% chance of survival when he was immunocompromised after a bone marrow transplant. Standard treatments had failed, but within two weeks of receiving the QIMR Berghofer cellular therapy through the SAS, he was well enough to go home. He is now healthy, head of his school house and captain of his soccer team. 

“This clinical experience demonstrates our breakthrough cellular therapy to target viruses has minimal side effects and has been effective in saving the lives of many children and adults who had otherwise run out of options.” 

“Q-Gen has been critical part of our ability to translate innovative T-cell therapies from the laboratory into the clinic. Its world-class GMP manufacturing capability and cell therapy expertise provide the quality, consistency and regulatory rigour needed to deliver these potentially transformative therapies to patients.” Professor Khanna said. 

Without NCRIS-supported facilities such as Q-Gen, compassionate access to this cell therapy would not be possible for Australian patients, and Koby might not have seen his 10th birthday.