Grant Scheme
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
- Establish cGMP compliance and apply for new TGA licences
- Provide subsidised access for researchers to licensed
facilities
- Support infrastructure for Smart Surfaces Manufacturing
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 (ARCBS-NTSD) 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 ARCBS-NTSD
of a ‘gap analysis’ to determine the outstanding
requirements of a facility to meet cGMP compliance. The facility
will request ARCBS-NTSD to undertake the gap analysis, which
will be fully funded by RISS Ltd through NCRIS funding.
Subsequently ARCBS-NTSD and the institution are expected to
negotiate a service contract whereby ARCBS-NTSD will provide
subsidised specialist services. This may include the purchase
of a suitable quality system by the facility from ARCBS-NTSD.
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 ARCBS-NTSD 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.
Infrastructure for Smart Surfaces Manufacturing
Funding will be provided for the delivery of a program that
provides an exchange between researchers and developers in
cGMP compliant human cell work and other relevant groups producing
or seeking to produce engineered surfaces or products. Funding
has been allocated over the project period to be provided
to Small Technologies Cluster Ltd to assist in the provision
of one full-time equivalent of multidisciplinary resources
to the Project.
Small Technologies Cluster represents collaboration between
key sector stakeholders: universities, industry and research
groups. It aims to address market failures in the provision
of prototype services and low volume manufacturing facilities.
The key objective of the project is to create a cluster of
new small scale technology manufacturing-based industries
across Australia that further expands upon the existing manufacturing
resources of the country. The consortium plans to deliver
through a range of showcase projects: enhanced micro fabrication
services, a bioprocessing facility and an incubation centre
for ‘high-tech’companies.
I. Access and Pricing
1. cGMP Compliance
The initial access policy for facilities seeking funding
will be as follows:
(i) facilities holding a current TGA license for the manufacture
of human blood and tissue for transplantation can apply
for a $50,000 pa subsidy to off-set their costs of maintaining
cGMP compliance program. Note: TGA License number must be
provided.
(ii) any facility can apply for a free gap analysis to identify
and quantify the tasks and resource requirements to prepare
the facility for a TGA licence application for the manufacture
of human blood and tissue for transplantation. The manpower
and time committed per facility per gap analysis will be
at the sole discretion of the RISS Board subsequent to receiving
advice from the ARCBS-NTSD.
(iii) subsequent to a gap analysis any facility can apply
for subsidised consulting services, to be provided by ARCBS-NTSD,
that relate to the establishment or extension of a cGMP
compliant system. Evidence of processes or activities towards
establishment or extension of a complaint system must be
provided with the application.
(iv) the RISS Ltd Board will decide on the application taking
into account their current subsidy guidelines, available
budget and if considered necessary advice from the Expert
Advisory Committee.
(v) if the application is approved, up to 50% of the ARCBS-NTSD’s
consulting services costs will be provided.
(vi) to receive a subsidy under (i) or (v), the facility
must enter into a contractual agreement with RISS Ltd to
receive the funds which will include an obligation to provide
subsidised access to researchers.
2. Access Support for Researchers
The initial access policy for researchers seeking funds
to subsidise the cost of accessing a licensed facility will
be as follows:
(i) the researcher will discuss the research project with
one or more facilities to reach a decision as to which licensed
facility is most appropriate for the project and the agreed
costs for the services to be provided.
(ii) the facility will apply to RISS Ltd to seek a subsidy
for the cost of the project:
a) for development of a cGMP compliant clinical trial
protocol to validate the research, and/or
b) for translation of the research to cGMP compliant standard
operating procedures (SOP’s) and documentation suitable
for ethics approval and an application for a TGA Clinical
Trials Notification (CTN) or Clinical Trials Exemption
(CTX); and/or
c) to undertake the cGMP manufacturing for the process
validation dry runs and/or the clinical trial.
(iii) the RISS Ltd Board will decide on the application.
(iv) if the application is approved, up to 50% of the cost
of the project will be provided to the facility which the
researcher will use, as a subsidy of the total cost of the
project. Typically, subsidies will be;
a) between $50,000 and $100,000 subsidy per annum per
project
b) 50% subsidy for eligible public-sector researchers
c) a similar or lesser discount for researchers from private
sector companies which are significantly owned by Australian
public sector research organisations. The extent of the
discount will be established by RISS taking into account
advice from Committees, IP ownership and beneficial rights
to the technology.
Grants will be provided under an agreement between RISS
and the applicant and include project plans and milestones.
RISS reserves the right to withhold or withdraw funding
based on milestone achievements or changes in plans.
II. Applications
Interested companies, organisations or institutions should
consider the following eligibility criteria:
- the grants available are for research infrastructure
only.
- the research infrastructure will be in the field of manufacture
of human cell or cellular based products for transplantation.
- infrastructure is related to development and implementation
of quality systems to achieve compliance with the cGMP and
possible TGA Licence for facilities.
- co-funding and/or collaborative funding is required (minimum
of a 1:1 ratio of Grant to Co-funding).
- “in kind” contributions will be considered
at a ratio to be determined (likely to be on a ratio of
1: 1.5 of in kind).
- applications for access to clean rooms and cell manufacturing
facilities will be considered for researchers who require
assistance in achieving cGMP compliance for their research
process.
See Application Process and
Timelines
|
