「細胞治療の開発プロジェクトに関する講演会 」の開催

大薬協発第564号
平成27年3月10日
各
位
大阪市中央区伏見町 2-4-6
大 阪 医 薬 品 協 会
「細胞治療の開発プロジェクトに関する講演会
〜南オーストラリア大学 Rob Short教授・副学長講演~」の開催について
南オーストラリア大学内に位置する共同研究センター Cooperative Research Centre for Cell
Therapy Manufacturing (CTM CRC)からProfessor Rob Shortが3月下旬に来阪されるのを機に標記の
講演会を開催することになりました。
Cooperative Research Centre for Cell Therapy Manufacturing (CTM CRC)は、オーストラリア
政府から助成を受けている研究機関で新しい細胞治療法として、糖尿病、慢性創傷等の治療のための
新技術を開発しています。
今回講演されるProfessor Rob Shortは、10年前に、英国にて開発されたmyskin™世界初の細胞治療
の開発・承認プロジェクトを率いた実績(*1)があり、この技術は角膜細胞移植にも応用されている
とのことです。
つきましては、本交流会に参加ご希望の方は、3月23日(月)までに大薬協ホームページ上
(http://www.dy-net.or.jp/)の「講演会等受付システム」にて、お申し込み頂きますようご案内申し
上げます。
敬
白
記
日
時:平成27年3月25日(水)10時~11時30分
会
場:大阪医薬品協会4階会議室
〒541-0044 大阪市中央区伏見町2丁目4番6号
電話 06-6231-9191
地図
http://www.dy-net.or.jp/map/index.htm
会
費:無料
定
員:15名(先着順)
講
師:Professor Dr.Rob Short
University of South Australia
Pro Vice Chancellor for IT, Engineering and the Environment
略歴 http://www.unisanet.unisa.edu.au/Staff/homepage.asp?Name=Rob.Short
プログラム
・細胞治療(糖尿病、慢性創傷等)の開発の現状
・Cell Therapy Manufacturingの業務内容
・質疑応答
(講演は英語で行われます。通訳はありませんが、質疑応答ではオーストラ
リア総領事館が協力して日本語での質問も可能です。)
(*1)講師の英国での実績の新聞記事
http://news.bbc.co.uk/2/hi/health/3660533.stm
http://news.bbc.co.uk/2/hi/health/3755249.stm
Cell Therapy
Manufacturing
Cooperative Research Centre
Our Vision
To provide new treatments and develop new materials-based manufacturing technologies to
increase the accessibility, affordability and efficacy of cell therapies.
About Us
The CRC for Cell Therapy Manufacturing, through [email protected] Ltd., will facilitate the cost-effective
manufacture and rapid translation of cell therapies into clinical practice.
With a total of $59M in cash and in-kind resources, including a $20M grant from the Australian
Government, the CRC will provide new treatments, and develop new materials-based manufacturing
technologies, for the treatment of conditions such as diabetes, chronic wounds, cardiovascular disease,
and immune-mediated diseases such as graft versus host disease.
Headquartered in South Australia, the CRC brings together the spectrum of skills and facilities required
to turn a promising cell into a viable cell therapy. The CRC’s national and international partners include
research providers, manufacturers, hospitals and charities. Underpinning this partnership is a newly
established cGMP manufacturing facility, designed to deliver cell-based therapeutics for the CRC’s firstin-man clinical trials.
Research
The CRC for Cell Therapy Manufacturing brings together materials scientists, cell biologists, bioprocess
engineers, clinicians and industry to increase the affordability, accessibility and efficacy of cell therapies.
Through its integrated research programs, the CRC focuses on increasing efficiencies and decreasing
costs for therapeutic cell isolation, expansion and delivery (collectively, cell therapy ‘manufacturing’), as
well as facilitating rapid translation of cell therapies into clinical practice.
Materials & Bioprocessing
The high manufacturing cost of cell therapies has
hampered the transition from the laboratory to the clinic.
The CRC will leverage its extensive knowledge in the
application of biomaterials/nanomaterials science and cell
biology to improve the efficiency of isolation, expansion
and delivery for a range of promising cells with the
potential for clinical applications.
Our researchers have a successful track record in
the application of smart materials technologies to the
development of products to treat conditions such as burns
and corneal damage, and to improve the performance of
culture ware and tissue engineered products.
Clinical Translation
We have the expertise and infrastructure to transition
promising cells from bench to bedside through our
purpose built cGMP manufacturing facility.
Together with experience and expertise in scale-up,
regulatory affairs and preclinical models, we are ideally
positioned to cost effectively design, manage and conduct
early phase clinical trials.
This capacity for seamless and rapid translation places
us in a unique position to benefit from significant
developments in the cell therapy industry and pave the
way for a range of cell therapy products.
Education
The CRC recognises the importance of education
as a key contributor to the ongoing development of
new cell therapies and treatments.
Through its tailored Entrepreneurial PhD (ePhD)
Program the CRC will ensure that graduates are
equipped with the necessary skills to understand
and drive the translation of research into new
therapies - supporting Australia’s expanding cell
therapy industry.
Cell Therapy
Manufacturing
Cooperative Research Centre
ctmcrc.com
Building MM
UniSA, Mawson Lakes Campus
Mawson Lakes SA 5095
T +61 8 8302 3503
E [email protected]
Cooperative Research Centre for
Cell Therapy Manufacturing
The CRC for Cell Therapy Manufacturing is focused on reducing the cost of manufacturing cell therapies,
making them more affordable and accessible to the patient, and reducing the cost burden to the healthcare
system. The CRC brings together scientists, clinicians, manufacturing and regulatory experts, as well as
commercial partners to rapidly develop and translate promising cell therapies into the clinic.
Research Programs
Materials & Bioprocessing
Clinical Translation
The high manufacturing cost of cell therapies has
We have the expertise and infrastructure to transition
hampered the transition from the laboratory to the clinic.
promising cells from bench to bedside through
The CRC will leverage its
our purpose built cGMP
extensive knowledge in the
manufacturing facility.
CASE STUDY
application of biomaterials/
Polymer Cell Delivery Patch:
nanomaterials science and cell
Together with experience and
Treatment of burns and non-healing wounds is typically
biology to improve the efficiency
expertise in scale-up, regulatory
achieved by spraying cells or by grafting synthetic skin.
of isolation, expansion and
affairs and preclinical models,
delivery for a range of promising
we are ideally positioned to cost
CRC researchers have previously developed a polymer
cells with the potential for
effectively design, manage and
patch with surface coating that allows attachment,
clinical applications.
conduct early phase clinical
growth and delivery of cells, and can be used with a
trials.
broad range of cell types.
Our researchers have a
successful track record in
This capacity for seamless and
the application of smart
rapid translation places us in
materials technologies to the
a unique position to benefit
development of products to
from significant developments
treat conditions such as burns
in the cell therapy industry and
and corneal damage, and
pave the way for a range of cell
to improve the performance
therapy products.
of culture ware and tissue
Example: delivery of skin cells on plasma polymerised
polymer patch heals 3 yr old foot ulcer.
engineered products.
D.B Haddow et al. JBMR 2002 64A. 80-87
Research Areas
Cells by Research Area
Mesenchymal
Stem Cells
Regulatory
T cells
Endothelial
Progenitor Cells
Pancreatic
Islets
✓
✓
✓
✓
✓
✓
✓
✓
✓
Isolation
Expansion
Delivery
✓
✓ = current project research areas
Our current research focuses on a number of specific cell types including mesenchymal stem cells, regulatory T cells,
endothelial progenitor cells and pancreatic islets. With each cell type, the initial objective is to optimise the cost of
manufacture through the development of smart surfaces and nanotechnology to improve isolation and/or expansion
protocols, reduce the use of costly reagents, improve cell viability and facilitate more efficient delivery mechanisms.
Cell Therapy
Manufacturing
Cooperative Research Centre
ctmcrc.com
Building MM
UniSA, Mawson Lakes Campus
Mawson Lakes SA 5095
T +61 8 8302 3503
E [email protected]
Contact Us
For more information or to enquire about
collaboration and partnering opportunities
please contact:
Dr Sherry Kothari
T +61 8 8302 5637
E [email protected]
CRC for Cell Therapy Manufacturing
Building MM
UniSA, Mawson Lakes Campus
Mawson Lakes SA 5095
ctmcrc.com
Building MM
UniSA, Mawson Lakes Campus
Mawson Lakes, SA, 5095
+61 8 8302 3503
Cell Therapy
Manufacturing
Cooperative Research Centre
The Cell Therapy Industry
Cell therapy (CT) is the use of cells to repair, replace or regenerate damaged or diseased tissue. An example
Industry challenges
Despite the undisputed curative potential of CTs, their commercialisation on a mass scale still presents
several challenges, one of which is cost. It is estimated that CTs could cost up to US$40-100K per dose,
Tcell expansion) and adhesive proteins (used in expansion of adherent cells such as MSCs, iPS cells).
CTM CRC - our approach
The potential impact of intervention with smart materials and surface coatings in CT manufacture is only just
technology, plasma polymerisation, (explained overleaf) provides a cheap and clean way to address the
ctmcrc.com
CTM CRC - spatial & temporal delivery
of growth factors
devices.
Cell expansion over 9 days compared with addition of growth factor and GAGs to
media (control) vs. GAG and GF binding at a smart surface
Controls (2 right hand columns):
factor recharged at day 4.
LH column: smart surface.
Columns 2-9
Advantages of plasma functionalised
surfaces
Coating not substrate dependent.
Highly controllable & reproducible surface
chemistry.
Surfaces tailored to cell type or biomolecule.
Plasma coatings can be stable for long periods
under ambient conditions.
Plasma coatings can be in cryopreserved products