Research use only

This restriction applies to every line of every quotation, whether the goods are a catalogue vial, a custom differentiation run, an engineered tissue construct, a culture device, or a characterisation service. It applies whether or not the individual listing repeats it. It survives delivery and applies to anyone the material is passed to.

The restriction applies to:

• cells, whether primary, immortalised, stem-cell derived, or genetically modified;
• engineered tissue constructs and three-dimensional models, whether living, fixed, or shipped for maturation in your laboratory;
• culture devices, microelectrode arrays, microfluidic chips, substrates, moulds and consumables;
• media, reagents, differentiation kits and coatings;
• contract culture, expansion, differentiation, banking, cryopreservation and characterisation services, and the data those services produce;
• documentation we supply alongside any of the above, including certificates of analysis and specification records.

It applies to derivatives. Expanded cells, tissue built from brokered cells, frozen banks and assembled constructs all carry the restriction forward. Changing the form of the material does not change the condition of supply.

Nothing supplied through Wetware World has been evaluated, cleared, approved, registered or certified by any medicines or medical device regulator, in any jurisdiction. We hold no marketing authorisation, no device clearance, no CE marking for a medical purpose, and no in vitro diagnostic registration.

None of it is:

• a medical device, an in vitro diagnostic device, or an accessory to either;
• a medicinal product, a drug, a biologic, or an advanced therapy medicinal product;
• a human cell, tissue or cellular and tissue-based product intended for implantation, transplantation, infusion or transfer into a human recipient;
• a food, a cosmetic, a supplement, or anything intended for consumption or topical application to a person;
• manufactured under good manufacturing practice, good laboratory practice, or any clinical-grade quality system, unless a specific quotation line states an accreditation and names the accredited supplier holding it.

We do not hold ISO 9001 or ISO 13485 certification ourselves. Where a project requires an accredited supplier, we source one and name the accreditation on the quotation line. That is a statement about the supplier, not about Wetware World.

Obtaining and maintaining the approvals that apply to your work is your responsibility, not ours and not the supplier's. We do not see your protocol, your facility, or your committee minutes.

Depending on the material and the work, the approvals that commonly apply include:

This table is not a compliance determination. Confirm which approvals apply with your biosafety officer and research office before ordering.

Where a supplier requires evidence of an approval before releasing material, we will tell you at quotation stage and we will not place the order without it.

You determine the biosafety level at which material will be handled in your facility. We will pass on the supplier's stated handling classification, the donor screening status where we have it, and any known agent-specific hazard. That information is an input to your determination. It is not the determination.

The appropriate containment level depends on the intended work as well as the material. The same primary human cells may require different handling for imaging, for transduction with a viral vector, or for procedures generating aerosols.

Two baseline assumptions are stated on documentation:

• Primary human and non-human primate cells and tissues should be handled using biosafety level 2 practices as a baseline, and treated as potentially infectious regardless of donor screening. Screening reduces risk but does not eliminate it, and no screening panel covers every agent.
• Genetically modified material, viral vectors and transduced lines require a containment determination specific to the vector and the insert, made before the material arrives.

If your facility cannot meet the containment level the material requires, state this at quote stage. The quote form asks what your facility can receive.

Safe handling is your responsibility from the moment the shipment is delivered. This includes the hazards of the packaging as well as of the biology.

• Dry ice is a cryogenic asphyxiation hazard in a confined space and a contact burn hazard. Open shipments in a ventilated area, with appropriate gloves.
• Liquid nitrogen dry shippers carry the same asphyxiation risk plus cold-burn risk, and require trained handling and a suitable receiving area.
• Cryovials warmed from liquid nitrogen can over-pressurise and fail violently. Thaw behind a shield, with a face shield and gloves.
• Storage must meet the condition stated on the specification from arrival onward. A vial that has been through an uncontrolled excursion in your freezer is no longer the material we quoted.
• Disposal of biological material, cultures, media and contaminated plastics must follow your institutional waste route and local law. Live cultures and genetically modified material typically require inactivation before disposal.

Personnel handling the material must be trained and qualified for it. Nothing supplied through Wetware World is intended for use by untrained personnel, in a teaching setting without supervision, or in a non-laboratory environment such as a home, a workshop, a school without appropriate facilities, or a community laboratory that cannot meet the required containment level.

Human-derived material carries obligations that follow the material beyond the point of sale.

Wetware World. Where a line involves human-derived material we will:

• ask the supplier for the consent basis under which the material was obtained, and pass on what they tell us;
• pass on donor screening results the supplier provides, and state where a panel was not run;
• pass on any ethics approval reference, biobank identifier, or material transfer agreement attached to the material;
• tell you where consent is limited, for example to non-commercial research, to a defined disease area, or excluding germline work or genomic data deposition;
• state when the supplier will not or cannot provide any of the above.

We do not independently verify consent documentation and are not the custodian of the donor relationship. Where the chain of custody or the consent basis is not documented to your satisfaction, do not proceed with the order, and notify us.

Buyer. As the recipient you are responsible for:

• ensuring your intended use is within the scope of the donor consent as communicated to you;
• obtaining ethics approval where your institution or jurisdiction requires it for the receipt, storage or use of human material;
• holding any licence your jurisdiction requires for storing relevant human material;
• not attempting to re-identify a donor, and not linking material to identifiable data outside an approved protocol;
• honouring any restriction on onward transfer, commercial use, derivative creation, or data deposition;
• handling any incidental finding through your institution's established route.

Do not send us identifiable donor information. Where a specification requires donor characteristics, describe them at the level of the attribute: age band, sex, disease status, and ancestry where scientifically relevant.

Animal-derived cells, tissues and sera carry their own obligations. Where relevant we pass on the species, strain, source establishment, and any origin certification the supplier provides, bovine serum origin certification in particular, which is routinely required for import and for downstream work.

Receipt of animal-derived material may require an import permit and may be subject to agricultural and veterinary controls independent of anything to do with research ethics. That is covered at export control, import permits and biosecurity. Where your own work involves animals, the applicable animal care approvals are yours to hold.

Our documentation reflects what the supplier reported and what was measured. Where a certificate of analysis exists we pass it through unaltered. Where a value is typical rather than lot-specific, the documentation states so. Where a test was not performed, the documentation states that.

We do not issue certificates for material we did not test, and we do not re-badge a supplier's certificate as ours. Independent verification of a parameter can be routed through a characterisation service and quoted as a separate service.

The research use attestation on the quote form is a condition of supply. An order cannot be placed without it. If we form a reasonable belief that material has been, or is intended to be, used in humans, in clinical diagnosis, or in any therapeutic application, we will decline to supply, cancel outstanding orders, and where the law requires it, report the matter.

Disclose a clinical destination at quotation stage. Such programmes require a different supplier, a different material grade and a different documentation set from the start, which Wetware World cannot supply in phase one.

Enquiries: [email protected].