Tissue Regeneration Company

Tissue regeneration corporation (TRC) is a multi-facility institute specializing in the preparation of a wide range of grafts based on the science of tissue engineering. Tissue engineering is an emerging science that aims to regenerate existing biological tissue and create new tissue using biological cells and biomaterials. Our competitive edge is derived from a strong focus on improving patient outcomes. The TRC team consists of highly dedicated and motivated professionals who are committed to finding solutions in order to achieve the highest standards in our work.

Feature

State of the art Production

Tissue Regeneration Corporation adheres to strict policies and procedures that were devised in line with the guidelines and standards of the FDA and UK codes of practice for productions of human derived therapeutic materials. All tissues are procured in a class 1000 environment and processed in sterile class 10-1000 clean rooms. The donor coordinator acquires the necessary consent for donation and interviews the family of each donor to obtain the donor’s medical history. TRC will only supply tissue from donors where lawful consent has been established. Where consent has been obtained by TRC, the tissue preparation is undertaken by our highly trained team who are constantly assessed using our specifically developed competency assessment program. Every donated tissue is tasted using several microbiologic and serologic testes such as HBs Ag, HBc Ab, HCV Ab, HIV Ab(1&2), HTLV Ab (I&II), RPR with ELISA method and complementary tests such as PCR method and FTA. Most of the donors are young, additionally our country has one of the lowest HIV infection rates in the world therefore we can provide some of the best quality tissues with minimal risk of AIDS transmission. All our bony grafts have both osteoinductive and osteoconductive properties confirmed by both in vitro and in vivo. Furthermore, the biomechanical properties of both the machined and large bones are routinely tested according to ASTM standards. Our work is consistent with the fundamentals of both national and international quality standards and ethical principles, specifically we obey all AATB and FDA rules in cellular and tissues based products. The services and facilities (including pharmaceutical grade cleanrooms) are all consistent with the current good manufacturing practice (cGMP). Freeze dried bone is lyophilized to measure 0.5 aW (water activity) eliminating the potential for microbial growth and minimizing autodegredative reactions. Irradiation is carried out to an established protocol ensuring a minimum dose of 25KGY is received by the tissue. Processed bone grafts are non cytotoxic as per ISO 10993-5. Final product release is undertaken as an independent function by quality assurance specialist personnel.

Quality assurance

All microbiology testing is performed internally by accredited laboratories specializing in donation screening. Final donor assessment and selection is undertaken by our own clinical specialist in tissue donation under supervision of coroner specialists. Donations are tracked by barcode including automated test result transfer to the database (the same database used for blood donation, processing and supply). This database has automated controls to prevent release of non-conforming tissue. Processes are validated in-house by the tissue development laboratory. All critical physical/chemical parameters are continuously monitored using a sophisticated IT package with appropriate warning levels and alarm states. This package continuously monitors (where appropriate) temperatures (of rooms, deep freezers, liquid nitrogen tanks etc), clean room pressures, air particles, oxygen levels, etc.

Products benefits

Tissues engineered products from allogenic sources are used in many surgical procedures because they are naturally biocompatible and can be remodeled to the patient’s own bone. They simplify potential revision procedures, and they eliminate second site morbidity and pain that may result from autograft removal. They are easy to use, take little time to prepare and are available pre-shaped to exact specifications. the end result is a facility, which ranks amongst the best in the world. TRC is staffed with highly trained dedicated doctors, scientists, technicians, nurses and all levels of support staff. This combination of a motivated professional workforce within a state-of-the-art facility ensures our commitment to safety, quality and efficacy of all our tissue grafts.

Ordering

Extensive inventories are available for allograft tissues by Tissue Regeneration Corporation. Please contact us up to 2 weeks before the required time and specify both the type and specification of your desired product. our staff will contact you as soon as possible and will send you the specifications along with digital photographs of the mentioned tissues and delivery options. We have a strict “Surgeon OK” program before your request is dispatched. In cases of urgency and special “rush orders”, we can arrange the shipment of tissues to the client in less than 48 hours.

SHIPPING AND INSTRUCTION TO USE

All shipping arrangements are made and handed on an individual basis. The product is usually delivered by either TRC transport or via the express special mail as special delivery in a padded envelope usually direct to the point of use e.g. theatre. More urgent delivery e.g same day or by specified time can be arranged at additional cost. Where an operation is graft critical, the patient must not be taken to theatre before the graft has arrived and its condition checked. Deep freeze products will be sent packed in dry ice (-70 °c). Vapor phase LN2 shipper (-130 °c) is also available in the event of extended transport durations. These products should be stored in -60 °c or lower temperature freezers as soon as they are received by the client. They should fully thaw prior to transplantation. Thawing protocols are attached to all frozen products. On the other hand, freeze-dried products should be transported and stored at room temperature until they are used. Such grafts should be stored away from direct sunlight at ambient temperature. They must be re-hydrated with a physiologic solution or the recipient’s own blood prior to implantation for at least 30 minutes.

Feature

State of the art Production

Tissue Regeneration Corporation adheres to strict policies and procedures that were devised in line with the guidelines and standards of the FDA and UK codes of practice for productions of human derived therapeutic materials. All tissues are procured in a class 1000 environment and processed in sterile class 10-1000 clean rooms. The donor coordinator acquires the necessary consent for donation and interviews the family of each donor to obtain the donor’s medical history. TRC will only supply tissue from donors where lawful consent has been established. Where consent has been obtained by TRC, the tissue preparation is undertaken by our highly trained team who are constantly assessed using our specifically developed competency assessment program. Every donated tissue is tasted using several microbiologic and serologic testes such as HBs Ag, HBc Ab, HCV Ab, HIV Ab(1&2), HTLV Ab (I&II), RPR with ELISA method and complementary tests such as PCR method and FTA. Most of the donors are young, additionally our country has one of the lowest HIV infection rates in the world therefore we can provide some of the best quality tissues with minimal risk of AIDS transmission. All our bony grafts have both osteoinductive and osteoconductive properties confirmed by both in vitro and in vivo. Furthermore, the biomechanical properties of both the machined and large bones are routinely tested according to ASTM standards. Our work is consistent with the fundamentals of both national and international quality standards and ethical principles, specifically we obey all AATB and FDA rules in cellular and tissues based products. The services and facilities (including pharmaceutical grade cleanrooms) are all consistent with the current good manufacturing practice (cGMP). Freeze dried bone is lyophilized to measure 0.5 aW (water activity) eliminating the potential for microbial growth and minimizing autodegredative reactions. Irradiation is carried out to an established protocol ensuring a minimum dose of 25KGY is received by the tissue. Processed bone grafts are non cytotoxic as per ISO 10993-5. Final product release is undertaken as an independent function by quality assurance specialist personnel.

Quality assurance

All microbiology testing is performed internally by accredited laboratories specializing in donation screening. Final donor assessment and selection is undertaken by our own clinical specialist in tissue donation under supervision of coroner specialists. Donations are tracked by barcode including automated test result transfer to the database (the same database used for blood donation, processing and supply). This database has automated controls to prevent release of non-conforming tissue. Processes are validated in-house by the tissue development laboratory. All critical physical/chemical parameters are continuously monitored using a sophisticated IT package with appropriate warning levels and alarm states. This package continuously monitors (where appropriate) temperatures (of rooms, deep freezers, liquid nitrogen tanks etc), clean room pressures, air particles, oxygen levels, etc.

Products benefits

Tissues engineered products from allogenic sources are used in many surgical procedures because they are naturally biocompatible and can be remodeled to the patient’s own bone. They simplify potential revision procedures, and they eliminate second site morbidity and pain that may result from autograft removal. They are easy to use, take little time to prepare and are available pre-shaped to exact specifications. the end result is a facility, which ranks amongst the best in the world. TRC is staffed with highly trained dedicated doctors, scientists, technicians, nurses and all levels of support staff. This combination of a motivated professional workforce within a state-of-the-art facility ensures our commitment to safety, quality and efficacy of all our tissue grafts.

Ordering

Extensive inventories are available for allograft tissues by Tissue Regeneration Corporation. Please contact us up to 2 weeks before the required time and specify both the type and specification of your desired product. our staff will contact you as soon as possible and will send you the specifications along with digital photographs of the mentioned tissues and delivery options. We have a strict “Surgeon OK” program before your request is dispatched. In cases of urgency and special “rush orders”, we can arrange the shipment of tissues to the client in less than 48 hours.

SHIPPING AND INSTRUCTION TO USE

All shipping arrangements are made and handed on an individual basis. The product is usually delivered by either TRC transport or via the express special mail as special delivery in a padded envelope usually direct to the point of use e.g. theatre. More urgent delivery e.g same day or by specified time can be arranged at additional cost. Where an operation is graft critical, the patient must not be taken to theatre before the graft has arrived and its condition checked. Deep freeze products will be sent packed in dry ice (-70 °c). Vapor phase LN2 shipper (-130 °c) is also available in the event of extended transport durations. These products should be stored in -60 °c or lower temperature freezers as soon as they are received by the client. They should fully thaw prior to transplantation. Thawing protocols are attached to all frozen products. On the other hand, freeze-dried products should be transported and stored at room temperature until they are used. Such grafts should be stored away from direct sunlight at ambient temperature. They must be re-hydrated with a physiologic solution or the recipient’s own blood prior to implantation for at least 30 minutes.

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