20 May 2010
Press release for Signing of Licensing Agreement for Clean Room System for UKM-MTDC Cell and Tissue Therapy Laboratory.
Skin is the largest organ in human covering the outer part of the body and act as the front line defense from bacteria and other harmful biological agents. It also plays an important role in our body heat regulation, evaporation control to prevent moisture loss and acts as a water resistant barrier so essential nutrients aren't washed out of the body.
Because of the soft and fragile structure, skin can be easily damaged under certain circumstances such as heat, chemical, traumatic injuries and difficult to heal diseases such as diabetic ulcers and pressure sores. In minor injuries, the skin will heal itself in time, some times with the formation of scars. However, for major injuries or non-healing ulcers, patients are susceptible to bacterial infection which could be fatal if the patient becomes septic.
The current treatment for massive skin loss is to do a split skin graft (SSG) where a layer of skin is removed from a healthy part of the body (donor site) and grafting it onto the wound. Although this is an effective treatment for burns and trauma cases, there are certain disadvantages:
i) SSG requires harvesting of a large area of skin from donor site which might increase the risk of infection,
ii) there may be a limited amount of good skin available for patients with massive skin loss,
iii) the process is more painful and may result in scarring,
iv) SSG is not advisable for patients with compromised healing abilities such as diabetic individuals.
Tissue Engineering Centre (TEC), a research centre on cell manipulation and tissue reconstruction was set up at Universiti Kebangsaan Malaysia (UKM) in 1999. This centre, under the supervision of Prof Ruszymah Hj Idrus, has developed an alternative treatment for skin injuries. In 2004, the centre successfully filed a patent for one of its products called “KULITKU”.
KULITKU is an engineered bilayer skin construct which is fully autologous. It is called autologus when the entire biological source was taken from the person and the constructed skin was grafted back to the same person. This fully autologous skin construct will eliminate the risk of immune rejection and cross contamination, and it is also a full-thickness bilayer skin. The initial skin biopsy for constructing the skin substitute is only 3cm2 and after separate culturing of keratinocytes and fibroblasts (cells which made up the epidermal and dermal layers in skin), a construct of about 100cm2 can be made. Scarring from this procedure will be minimal as only a small piece of skin will be required from the donor site. It would be less painful and had reduced risk of infection especially for patients with impaired wound healing.
KULITKU was recognized internationally when it won a gold medal in the 23rd Geneva International Exhibition of Invention in 2004, a gold medal in the International Invention, Innovation and Technology Exhibition (ITEX 2003) and a gold medal in the Science and Technology (S&T) EXPO in 2003.
Even though KULITKU patent was granted in 2008, the inavailability of an accredited lab has halted the process of bringing the innovation to the bedside. Due to this, UKM is in the process of setting up a cGMP facility to conduct clinical trial for KULITKU. cGMP is the Current (Code of) Good Manufacturing Practices adopted by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, and purity. UKM, with the collaboration of MTDC (Malaysian Technology Development Corporation), have successfully initiated the construction of a cGMP facility located on the 12th Floor of UKM Medical Centre since early 2010. This will be the first cGMP facility for human cell and tissue processing in Malaysia that will be accredited by National Pharmaceutical Control Bureau (NPCB) under the Ministry of Health. It will also serve as a gateway for other innovative products from TEC such as cartilage, bones, corneas and other cellular and tissue based therapies such as stem cell therapy to reach the Malaysian patients.
The proposed facility will consist of clean rooms and product testing facilities. This facility design is tailored for human cells and tissue processing for clinical trials and is capable of full cGMP manufacturing / production. The facility will be suitably equipped to develop and scale-up process/product technologies related to tissue engineering and cell therapies. It will act as a hub for other innovative biotechnology products from other universities around Malaysia and the region. With competitive markets in cell and tissue products, it is vital for UKM and MTDC to produce a quality product of international standard via an accredited cGMP facility. This facility will be an icon of Malaysia and UKM will be proud to have the facility fully operational and serving the public in the near future. The facility will conduct its first clinical trial for KULITKU sometime in the middle of 2011.
Since the initiation of the cGMP facility construction, UKM has engaged a consulting firm, Cell Therapies Pty Ltd (CT) from Melbourne, Australia. Cell Therapies under their managing director, Mr. Raymond Wood, is an independent company set up to manage the commercial interface to Peter MacCallum Cancer Centre’s licensed manufacturing resources. Cell Therapies have nine years of experience in advanced cell therapies with more than 1000 products produced annually. Their services range from laboratory rental through to fully-integrated planning and execution of clinical trials that involve cellular therapeutics manufactured in code of current Good Manufacturing Practice (cGMP) and Therapeutic Goods Administration (TGA) accredited facilities. Cell Therapies operates under strict codes of practice and their extensive experience in building cGMP labs in Australia, clinical trial design and licensed manufacturing will greatly aid UKM in the process of setting up their clean rooms and getting their facility accredited. The co-operation between the two entities is mainly to build the first human cell and tissue therapy laboratory with references to TGA, an Australian guideline. The collaboration had started since 2009 and will continue until the laboratory is fully accredited and can be fully operational.
The signing of the license agreement that took place today was represented by Mr. Raymond Wood, Managing Director of Cell Therapies Pty Ltd, and Prof. Dr. Nor Embi, Director of Centre for Innovation and Collaboration, UKM. The signing signifies the transfer of an internationally recognized quality system to the UKM-MTDC cGMP facility, an important step that will further enhance production in the cGMP facility for regional and international markets.
For more information, please contact:
Prof Dr Ruszymah binti Haji Idrus
Pusat Kejuruteraan Tisu
Pusat Perubatan UKM