Treatments for skin injuries have recently advanced tremendously. Such treatments include allogen... more Treatments for skin injuries have recently advanced tremendously. Such treatments include allogeneic and xenogeneic transplants and skin substitutes such as tissue-engineered skin, cultured cells, and stem cells. The aim of this paper is to discuss the general overview of the quality assurance and quality control implemented in the manufacturing of cell and tissue product, with emphasis on our experience in the manufacturing of MyDerm®, an autologous bilayered human skin substitute. Manufacturing MyDerm® requires multiple high-risk open manipulation steps, such as tissue processing, cell culture expansion, and skin construct formation. To ensure the safety and efficacy of this product, the good manufacturing practice (GMP) facility should establish a well-designed quality assurance and quality control (QA/QC) programme. Standard operating procedures (SOP) should be implemented to ensure that the manufacturing process is consistent and performed in a controlled manner. All starting m...
The International Journal of Lower Extremity Wounds, Sep 1, 2017
Open fracture Gustilo-Anderson grade IIIC is associated with higher risk of infection and problem... more Open fracture Gustilo-Anderson grade IIIC is associated with higher risk of infection and problems with soft tissue coverage. Various methods have been used for soft tissue coverage in open fractures with large skin defect. We report a case of a patient who had grade IIIC open fracture of the tibia with posterior tibial artery injury. The patient underwent external fixation and reduction. Because of potential compartment syndrome after vascular repair, fasciotomy of the posterior compartment was performed. This wound, however, became infected and because of further debridement, gave rise to a large skin defect. A tissue engineered skin construct, MyDerm(TM) was employed to cover this large defect. Complete wound closure was achieved 35 days postimplantation. The patient then underwent plating of the tibia for nonunion with no adverse effect to the grafted site. The tibia eventually healed 5 months postplating, and the cosmetic appearance of the newly formed skin was satisfactory.
The second author's name appears incorrectly. The correct name is: Maarof Manira. The correct... more The second author's name appears incorrectly. The correct name is: Maarof Manira. The correct citation is: Seet WT, Manira M, Khairul Anuar K, Chua K-H, Ahmad Irfan AW, et al. (2012) Shelf-Life Evaluation of Bilayered Human Skin Equivalent, MyDerm™. PLoS ONE 7(8): e40978. doi:10.1371/journal.pone.0040978
<p>Paraffin section of MyDerm™ at 72 hours storage showing distinct keratinocytes and fibro... more <p>Paraffin section of MyDerm™ at 72 hours storage showing distinct keratinocytes and fibroblasts layers in immunohistochemistry after incubation with Rabbit Anti-Human Polyclonal Collagen III Primary Antibody (green) and Mouse Anti-Human Cytokeratin 14 Monoclonal Antibody (red).</p
<p>Population doubling time (PDT) of cells at different periods of MyDerm™ storage time aft... more <p>Population doubling time (PDT) of cells at different periods of MyDerm™ storage time after 144 hours culture.</p
<p>The gene expression levels of cells relative to GAPDH at different periods of MyDerm™ st... more <p>The gene expression levels of cells relative to GAPDH at different periods of MyDerm™ storage time.</p
Public awareness on cell and tissue therapy treatment has inspired many research laboratories to ... more Public awareness on cell and tissue therapy treatment has inspired many research laboratories to produce cell and tissue based technology in treating patients. Translation from research base products to clinical application requires a set of internationally recognized guideline to be followed. Good Manufacturing Practise (GMP) is a guideline to ensure the quality and safety of products offered to the consumer meet the standards. Production aspects in a GMP compliant laboratory built for production of human cell and tissue will be discussed briefly in reference to the Pharmaceutical Inspection Convention/ Scheme (PIC/S) Guide and Good Distribution Practice (GDP) Guide. Critical materials that will be used in the production must be clearly defined. Production personnel dedicated to perform the manipulation must be trained to achieve the competency level required. Final product must be handled in a proper manner to maintain the quality and safety of the product. GMP is an international...
<p>MyDerm™ (9.6 cm<sup>2</sup> construct) before being processed for analysis.&... more <p>MyDerm™ (9.6 cm<sup>2</sup> construct) before being processed for analysis.</p
Skin plays an important role in defense against infection and other harmful biological agents. Du... more Skin plays an important role in defense against infection and other harmful biological agents. Due to its fragile structure, skin can be easily damaged by heat, chemicals, traumatic injuries and diseases. An autologous bilayered human skin equivalent, MyDermTM, was engineered to provide a living skin substitute to treat critical skin loss. However, one of the disadvantages of living skin substitute is its short shelf-life, hence limiting its distribution worldwide. The aim of this study was to evaluate the shelf-life of MyDermTM through assessment of cell morphology, cell viability, population doubling time and functional gene expression levels before transplantation. Skin samples were digested with 0.6 % Collagenase Type I followed by epithelial cells dissociation with TrypLE Select. Dermal fibroblasts and keratinocytes were culture-expanded to obtain sufficient cells for MyDermTM construction. MyDermTM was constructed with plasma-fibrin as temporary biomaterial and evaluated at 0,...
Treatments for skin injuries have recently advanced tremendously. Such treatments include allogen... more Treatments for skin injuries have recently advanced tremendously. Such treatments include allogeneic and xenogeneic transplants and skin substitutes such as tissue-engineered skin, cultured cells, and stem cells. The aim of this paper is to discuss the general overview of the quality assurance and quality control implemented in the manufacturing of cell and tissue product, with emphasis on our experience in the manufacturing of MyDerm®, an autologous bilayered human skin substitute. Manufacturing MyDerm® requires multiple high-risk open manipulation steps, such as tissue processing, cell culture expansion, and skin construct formation. To ensure the safety and efficacy of this product, the good manufacturing practice (GMP) facility should establish a well-designed quality assurance and quality control (QA/QC) programme. Standard operating procedures (SOP) should be implemented to ensure that the manufacturing process is consistent and performed in a controlled manner. All starting m...
The International Journal of Lower Extremity Wounds, Sep 1, 2017
Open fracture Gustilo-Anderson grade IIIC is associated with higher risk of infection and problem... more Open fracture Gustilo-Anderson grade IIIC is associated with higher risk of infection and problems with soft tissue coverage. Various methods have been used for soft tissue coverage in open fractures with large skin defect. We report a case of a patient who had grade IIIC open fracture of the tibia with posterior tibial artery injury. The patient underwent external fixation and reduction. Because of potential compartment syndrome after vascular repair, fasciotomy of the posterior compartment was performed. This wound, however, became infected and because of further debridement, gave rise to a large skin defect. A tissue engineered skin construct, MyDerm(TM) was employed to cover this large defect. Complete wound closure was achieved 35 days postimplantation. The patient then underwent plating of the tibia for nonunion with no adverse effect to the grafted site. The tibia eventually healed 5 months postplating, and the cosmetic appearance of the newly formed skin was satisfactory.
The second author's name appears incorrectly. The correct name is: Maarof Manira. The correct... more The second author's name appears incorrectly. The correct name is: Maarof Manira. The correct citation is: Seet WT, Manira M, Khairul Anuar K, Chua K-H, Ahmad Irfan AW, et al. (2012) Shelf-Life Evaluation of Bilayered Human Skin Equivalent, MyDerm™. PLoS ONE 7(8): e40978. doi:10.1371/journal.pone.0040978
<p>Paraffin section of MyDerm™ at 72 hours storage showing distinct keratinocytes and fibro... more <p>Paraffin section of MyDerm™ at 72 hours storage showing distinct keratinocytes and fibroblasts layers in immunohistochemistry after incubation with Rabbit Anti-Human Polyclonal Collagen III Primary Antibody (green) and Mouse Anti-Human Cytokeratin 14 Monoclonal Antibody (red).</p
<p>Population doubling time (PDT) of cells at different periods of MyDerm™ storage time aft... more <p>Population doubling time (PDT) of cells at different periods of MyDerm™ storage time after 144 hours culture.</p
<p>The gene expression levels of cells relative to GAPDH at different periods of MyDerm™ st... more <p>The gene expression levels of cells relative to GAPDH at different periods of MyDerm™ storage time.</p
Public awareness on cell and tissue therapy treatment has inspired many research laboratories to ... more Public awareness on cell and tissue therapy treatment has inspired many research laboratories to produce cell and tissue based technology in treating patients. Translation from research base products to clinical application requires a set of internationally recognized guideline to be followed. Good Manufacturing Practise (GMP) is a guideline to ensure the quality and safety of products offered to the consumer meet the standards. Production aspects in a GMP compliant laboratory built for production of human cell and tissue will be discussed briefly in reference to the Pharmaceutical Inspection Convention/ Scheme (PIC/S) Guide and Good Distribution Practice (GDP) Guide. Critical materials that will be used in the production must be clearly defined. Production personnel dedicated to perform the manipulation must be trained to achieve the competency level required. Final product must be handled in a proper manner to maintain the quality and safety of the product. GMP is an international...
<p>MyDerm™ (9.6 cm<sup>2</sup> construct) before being processed for analysis.&... more <p>MyDerm™ (9.6 cm<sup>2</sup> construct) before being processed for analysis.</p
Skin plays an important role in defense against infection and other harmful biological agents. Du... more Skin plays an important role in defense against infection and other harmful biological agents. Due to its fragile structure, skin can be easily damaged by heat, chemicals, traumatic injuries and diseases. An autologous bilayered human skin equivalent, MyDermTM, was engineered to provide a living skin substitute to treat critical skin loss. However, one of the disadvantages of living skin substitute is its short shelf-life, hence limiting its distribution worldwide. The aim of this study was to evaluate the shelf-life of MyDermTM through assessment of cell morphology, cell viability, population doubling time and functional gene expression levels before transplantation. Skin samples were digested with 0.6 % Collagenase Type I followed by epithelial cells dissociation with TrypLE Select. Dermal fibroblasts and keratinocytes were culture-expanded to obtain sufficient cells for MyDermTM construction. MyDermTM was constructed with plasma-fibrin as temporary biomaterial and evaluated at 0,...
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Papers by Wan Tai Seet