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 CTM@CRC 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
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