Infrastructure for cGMP Manufacture of Human Cells or Cellular Based Products for Transplant

Current and proposed facilities for the manufacture of human cells or cellular based products for transplant will be supported to:

Maintain existing cGMP compliance and TGA licences

  1. Establish cGMP compliance and apply for new TGA licences
  2. Provide subsidised access for researchers to licensed facilities
  3. Support infrastructure for Smart Surfaces Manufacturing
  4. Maintenance of TGA-licensing for existing cGMP-compliant Facilities

There are currently several facilities that are cGMP-compliant and TGA-licensed. The high costs associated with maintenance of TGA-licensing presents a substantial impediment to external researchers from accessing these facilities, since these costs would ultimately need to be passed on to the researcher.

TGA-licensed cGMP-complaint facilities will enter into a contractual agreement with RISS Ltd to obtain NCRIS Funds to subsidise the costs associated with maintaining their TGA licenses. In return, the facilities will agree to provide access to researchers to these facilities.

To further assist in reducing the cost of access to these facilities by researchers, the facilities will also be provided with NCRIS Funds through their agreement with RISS Ltd to subsidise these access costs.

Establishment of cGMP compliance for unlicensed facilities

A number of facilities suitable for the manufacture of human cells or cellular-based products for transplant are currently planned or under construction. To be able to provide these services, they will need to achieve cGMP compliance and be licensed by the TGA. The Australian Red Cross Blood Service National Transplantation Services Division (the Blood Service - TS) is ideally qualified to assist facilities achieve cGMP compliance through delivery of the ‘national resource for cGMP compliance’.

The ‘national resource for cGMP compliance’ comprises an accumulation of intellectual property, skills and expertise able to undertake gap analysis, provide advice and guidance and project manage the introduction, validation and ongoing audit/monitoring of compliant cGMP Quality Systems.

The first stage of this process will be the conduct by the Blood Service - TS of a ‘gap analysis’ to determine the outstanding requirements of a facility to meet cGMP compliance. The facility will request the Blood Service - TS to undertake the gap analysis, which will be fully funded by RISS Ltd through NCRIS funding.

Subsequently the Blood Service - TS and the institution are expected to negotiate a service contract whereby the Blood Service - TS will provide subsidised specialist services. This may include the purchase of a suitable quality system by the facility from the Blood Service - TS.

The facility will then be able to apply to RISS Ltd for NCRIS Funding to subsidise the costs associated with implementation of the national resource for cGMP compliance. If approved, the facility will enter into a contractual agreement with RISS Ltd whereby NCRIS Funds will be provided.

If the facility is successful in gaining a TGA licence, they will then be able to apply for NCRIS Funding to subsidise the costs of maintaining licensing and also for subsidised researcher access, if sufficient funds are available.

Note: existing licensed facilities may seek these services from the Blood Service - TS for new, unlicensed processes. The procedures outlined above, including seeking funding from RISS Ltd to subsidise the costs associated with implementing a cGMP-compliant system, will apply equally to these facilities.

Access Support for Researchers

Funding will be available to subsidise the cost of researchers accessing cGMP-compliant, TGA-licensed facilities. These funds will be provided to the facility following approval by RISS Ltd of an application for a subsidy.

For further information please refer to our Application page.