SUU, Alm.del - 2009-10 - Bilag 104: Henvendelse af 19/11-09 fra Johannes Abildtrup vedr. humane celler og væv

THE AIMS FOR THE CONSTRUCTIONOF THE VIVOX TC-BIOSYSTEM HASBEEN:High precision with respect to delivering the temperatureand gas conditions asked forThe possibility of working not only with oxygen (very lowpO2to ambient), but also with a number of gassesrelevant and / or naturally found in living organisms, inparticular the mammalian - including the human body.A precise temperature control making it possible to testthe combined effect of physiologic small changes intemperature and gas conditionsA clean room facility better than ISO Class 3.A bio safety level of min class 2-3Possibility of disinfecting the Biosystem (heat and steam)in-between runs and experimentsEnough space for small instruments such as amicroscope and video camera to be placed in theworkspaceAvoidance of confounding influence of reoxygenation ofmaterials due to transfer of materials as in conventionalprocedures involving standard incubators, bioreactors andflow benchesEnsuring correct ergonomics by mean of a elevatingsystem.The possibility of continuous monitoring, the possibility oftraceability and running documentation to secure thefulfilment of cGMP guidelines.The possibility for storing and designing job functions forthe box and the possibility of pre-programming job-functions and protocols or even during runs/experimentsreprogramming job functions, such as changes inpressure, temperature and gas conditions in order tomimic a specific in vivo situations.The possibility of interfaces in the workspace allowing thecollection of data from the signal transmitting equipment(such as ph meters etc.) to be read and/or loggedexternallySpecified maximum allowable vibration of the inner shell.(No vibrations can be measured in the TC Biosystem).The option of remote control, servicing and monitoring ofthe system over the Internet.Patented in: US, Ca, Europe, AU and JPNew pending patents

THE GOAL OFVIVOX TC- BIOSYSTEMBecause of their intended use, good quality iscrucial to cells and tissue. Therefore handlingand processing must be organised in a way toensure high quality. Some of the goals of tissueengineering are the production of patientspecific cells, tissues and organs fortransplantation or autografts. At present,problems with reproducibility bedevil researchon adult stem cells. Optimal safe and correcthandling of cellular biotechnological material isindeed needed for clinical trials and fortreatment of patients.A new patented closed facility for combinedhandling and growing of biological material atvalidated stable and traceable temperature andphysiologic gas conditions has been invented bythree medical doctors: Jan A. Villadsen, PeterEbbesen and Peter Mosborg Petersen, partnersViVoX ApS, Science Park Aarhus, Denmark inorder to solve some of the challenges cellresearch and cell production encounters.The patented invention that includes both anapparatus and a method ensures a facility formaintenance of uncontaminated live cells formedical treatment, for diagnostic and basiccellular research, as well as securing optimalundisturbed clean in vivo gas conditions for thetime needed, (weeks and months).To achieve this goal a unique construction thatgives optimal conditions for human and animalcells and allows compliance with the moststringent coming regulatory demands has nowbeen made.It is a facility that is foreseen to be neededglobally for safety, quality control, and goodmanufacturing practice (GMP) good cellularculturing practices (GCCP) and low runningcosts.

Several Danish Research Institutes has alreadydocumented the advantage of the invention. Anumber of cellular characteristics have alreadybeen demonstrated to benefit from correcthandling and incubation, mimicking theconditions in the living body.The patented new enclosure facility is highlysuitable within the areas of in vitro fertilisation,production of patient specific cells or tissues,gene therapy, biological engineering, stem cellresearch, pharmaceutical testing and biologicalresearch in general.

2ndlevel of containment: Maintaining a nearbyequal or negative pressure inside the work-volume with regard to the atmospheric pressurein order to keep a pre-set physiological gascomposition in the workspace.3rdlevel of containment: The regulation of theTC Biosystem and the bio-safety is provided byintroducing a double wall enclosure system withan even lower negative total and partialpressure than in the workspace.The containment levels secures in addition thattemperature can be kept extremely precise(temp. can be regulated more precise than setpoint temp.�0.2�C) and in addition heat loss islittle.The TC Biosystem principles provides an optimalsafety against contamination of the processeditems as well as securing optimal safety againstpolluting the environment and securescontinuously stable and traceable isotherm andisobar conditions (also for humidity, pO2 andpCO2) in the workspace and airlock of the ViVoXTC Biosystem™.

STATE OF THE ARTPresent day equipment solves either personalsafety or protection of material againstcontamination but not both at the same time.In the ViVoX TC Biosystem™ three problems aresolved in one new construction. Safety for theoperator and the environment, protectionagainst contaminating the patient specificmaterial and optimal handling and growthconditions for the cells.

THE TC- BIOSYSTEM PRINCIPLESThe new ViVoX TC-Biosystem™ support theoperation of treatment manipulationexperiments and handling/maintenance ofexperiments and diagnostics in a pre-setphysiologic or deliberately pre-set non-physiological environment at very precise gastensions, humidity and temperature.The new glove biosystem provides three levelsof containment for these operations by meansof:1stlevel of containment: Providing a closedcompartment.