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Safety equipment in a cell culture laboratory includes primary barriers such as biosafety cabinets, enclosed containers, and other engineering controls designed to remove or minimize exposure to hazardous materials, as well as personal protective equipment PPE that is often used in conjunction with the primary barriers. The biosafety cabinet i. For more information, see Cell Culture Hood.
Personal protective equipment PPE form an immediate barrier between the personnel and the hazardous agent, and they include items for personal protection such as gloves, laboratory coats and gowns, shoe covers, boots, respirators, face shields, safety glasses, or goggles. They are often used in combination with biosafety cabinets and other devices that contain the agents or materials being handled. Note: You clicked on an external link, which has been disabled in order to keep your shopping session open.
Search Thermo Fisher Scientific. Search All. An anteroom is a room directly adjacent to a tissue culture room whose sole purpose is to provide support for the tissue culture room.
2012 Lab 9
An anteroom is not a large multipurpose laboratory. Give feedback. Ensure that they both know the collection time and the anticipated delivery time. Exchange contact details in case problems arise.
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Keep shipping reference numbers such as Airway Bill Numbers and share them with the receiver of the package in case of delays or misrouting. Inform the recipient of what type of containers are being sent and the state of the cells and provide details of what to do with the cells when they arrive, to ensure that they have the correct medium available and that they are familiar with the growth characteristics of the cells.
Ask the recipient to notify you when the cells arrive or when the cells have failed to arrive within a reasonable period. Ask the recipient to establish, as a high priority, their own frozen stock of the cells so that repeated transport is not needed.
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Various regulations must be complied with when sending cells to other laboratories. These include legal requirements of various countries and regulations established by individual carriers. It is strongly recommended that full details of these are obtained before any transport is attempted. Regulations concerning the transport of potentially dangerous goods are published by the International Air Transport Association IATA, and updated annually. There may also be issues of consent, with respect to use, distribution and export from specific countries, and the relevant documentation may be required by research funders and by journals.
It is beyond the scope of these Guidelines to spell out in detail the full regulations. However, the following points may be useful in providing general guidance:. While there are few restrictions on the movement of cell cultures within the European Union, importation of certain animal cells from other countries into the UK requires a permit from the Department for Environment, Food and Rural Affairs DEFRA, This is particularly important for cells from agricultural species, including poultry, where there is a serious risk of importing non-endemic viruses.
Some countries are concerned about export of indigenous genetic resources, which could encompass tissues and cell lines, and may have imposed restrictions on export for any type of research, but especially for potentially commercial applications. Apart from the USA and Australia, few countries have specific regulations regarding the import of cell lines and hence sending cells abroad should not present major problems.
Safety Data Sheet (SDS)
However, if material is classified as Advisory Committee on Dangerous Pathogens category 2 or above ACDP, , special conditions apply and the sender must undergo formal training. A copy of the permit should be taped to the outside of the package. For some countries, it is not just the cell line that is relevant but also whether the medium contains serum and its source. Use of a serum replacement or serum-free medium can provide a simple solution. Patient consent is usually required for the use of human tissue samples and ownership must be defined. Transfer of cell lines from one laboratory to another may require a material-transfer agreement MTA.
It is not the purpose of this document to describe the methodology for developing primary cultures and deriving cell lines from them, because extensive literature is already available. However, there are specific precautions and procedures that those proposing to do this type of work should be aware of. Research involving human tissue samples will require ethical approval. To this end the Human Tissue Act legislates on the use of human tissue samples for a number of scheduled purposes including research.
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Informed patient consent may be required to store and use human tissue samples for research purposes and a Human Tissue Authority licence may be required to store human tissue samples for research purposes. Once a human cell line is established it is no longer covered by the Act. Any patient data where the patient name is recorded should be managed under the Caldicott Principles. These require the laboratory to have a Caldicott Guardian to assure compliance with these guidelines Caldicott, The Human Fertilisation and Embryology Act amended legislates on research using early human embryos up to 14 days of development or the first signs of primitive streak formation and is regulated and licensed by the Human Fertilisation and Embryology Authority HFEA.
The HFEA is not concerned with tissues from later-stage embryos or foetuses e. An MTA should accompany all transfers of created cell lines between organisations and should define specific details including ownership, intellectual property rights and patent rights. ASPA is not directly relevant to the derivation of a cell line from an animal that has been killed by a schedule 1 method. However, it is relevant if any regulated procedure is required, such as tissue biopsy of a live animal, administration of substances, or derivation of a genetically altered animal.
It is also relevant if cells are to be introduced into a live-born animal or animal embryo. While for most experiments it will make little difference with respect to regulation under ASPA whether the cells are of animal or human origin, some involving the latter may be considered contentious, especially if they concern the reproductive system or have the potential to lead to human characteristics developing in an animal see Academy of Medical Sciences Report on Animals Containing Human Material www.
New regulations and guidance on this type of research are being introduced and such experiments will be considered by the new Animals in Science Committee of the Home Office. The principal aim of the REC is to safeguard the rights, safety, dignity and well-being of individuals participating in research see Box 2. In addition most NHS Trusts and Universities will have their own Research and Development Departments, which will approve all proposed new research, involving human tissue samples, before submission for ethical approval and scientists should make themselves familiar with their host organisation's local rules and policies.
The HTA also licenses a number of activities including removal of relevant material from a deceased person and storage of relevant material for a Scheduled Purpose. Consent is the fundamental principle of the legislation.
Different consent requirements apply when dealing with tissue from the deceased and the living. Scotland has separate legislation, the Human Tissue Scotland Act, Both acts are broadly similar in principle, but the Scottish legislation is based on authorisation rather than consent Human Tissue Scotland Act, This includes blood, tissues and organs but does not include:. Material that contains no cells, for example, serum, plasma and urine providing the urine is acellular.
Material created outside of the body in vitro , for example, embryos and cell lines. Therefore primary human tissue and cells i. Cell lines derived from expansion of primary cell cultures in vitro are not relevant material, as all of the original cells will have divided and so the cell line has been created outside of the human body.
The storage of cell lines created from primary human tissue, for research purposes, does not require an HTA licence and the use of such cell lines is not covered by the HT Act or regulated by the HTA. However obtaining, retention and storage of any of the primary material from which the cell line was derived will be subject to the HT Act and HTA regulation, as will any cell lines derived with the intention of use in human therapy under the HTA Under the HT Act consent is not required to store and use human tissue for research including the creation of cell lines if:.
The tissue sample is from a living person and the proposed work is part of a research project or study approved by an NHS REC and the identity of the donor remains unknown to the researcher. The tissue sample is being held for use in an ethically approved research project or study, or where approval is pending. The tissue sample is being stored before transfer elsewhere, provided it is held for no longer than 1 week.
The tissue sample is being held while it is processed with the intention to extract components that are not relevant material and provided the processing does not take longer than 1 week. All scientists working in the UK who are producing cell lines from primary human material, for research purposes, should make themselves familiar with Codes 1 Consent , 9 Research and 5 Disposal. One of the statutory functions of the HFEA is to license and monitor establishments undertaking human embryo research and this will include production of human embryonic stem cell hESC lines.
Developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation. Although these purposes did not preclude the derivation of human ESC, the reasons for doing so would have been limited by them.
nasvefastband.tk The Act had been passed before human ESC had first been derived, and there had been several other scientific advances, notably SCNT or cloning, which suggested that it needed updating. Enabling any such knowledge to be applied in developing treatments for serious disease HFEA, The current version of the Act, passed in , incorporates a number of very significant amendments, which were again made to accommodate rapid advances in science as well as changes in public attitudes and clinical practice Lovell-Badge, In summary the HFEA can grant research licences for up to 3 years for individual, peer-reviewed research projects.
All new applications for a research licence must also have ethics approval see Section 2. The HFEA charge an administration fee for granting and renewing project licences, which varies depending on the nature of the research. However, as with any other cell line, their use in a clinical setting would be regulated as described below. Research involving hESCs and other human tissue-derived cell lines will involve different regulatory authorities at different stages.
For example, cell-based products that involve the destruction of a human embryo in their formation are initially licensed by the HFEA.
Once an embryo has been disaggregated it is no longer subject to HFEA regulation. If the cells replicating from such a disaggregated embryo are intended for application on humans, they are then subject to the HTA up to the point of the first representative cell bank for that cell line. These regulations are administered by the HTA. However, hESC lines derived purely for research are not subject to this regulation. Favourable opinion from a recognised research ethics committee is also required for any clinical trial of a medicinal product see Section 2. Most human cell-based medicinal products intended for cell therapy or tissue engineering purposes will be classified as ATMPs.
If opinion is favourable the MHRA will be responsible, in the UK, for authorising the clinical trial, inspecting the trial and issuing a manufacturing licence. This provides practical advice and information on best practice and current legal requirements for conducting clinical trials in the UK. There are many who might lay claim to the ownership of specimens and their derivatives, including the donor and relatives, the surgeon and pathologists, the hospital authority where the sample was taken, the scientists engaged in the research, the institution where the research work was performed, the funding body and any collaborating commercial companies.
The ultimate control of ownership, intellectual property rights and patent rights will need to be negotiated by the various interested parties. Most universities and research institutes will have a research office that deals with such negotiations, as do most of the larger funding agencies. An MTA is a legally binding contract governing the transfer of research materials between two organisations where the recipient intends to use the materials for his or her own research purposes.
Biological materials including reagents, cell lines, plasmids and vectors are the most frequently transferred materials and the MTA will define the rights of the provider and recipient with respect to the materials and any derivatives. This should include details of ownership, intellectual property rights and patent rights.
The MTA should be signed by the legal representative of both the provider and recipient before any materials are transferred.