FAQ

Safety

Are human biological materials safe?

No test procedure can absolutely guarantee the absence of any infectious agents on human biological materials.

As a result, all human biological materials should be handled as potentially infectious by qualified personnel only, wearing adapted PPE (Personal Protective Equipment) and following appropriate work Safety Practices.

Which biological safety tests are done?

As requested by French law, all donors are tested negative for the presence of HIV1&2, hepatitis B and C viruses. Blood tests are carried out under cooperation with accredited and independent laboratories (COFRAC) within days or weeks preceding the surgery.

Do I get the results of these tests?

Alphenyx provides a Certificate of Analysis (CoA) for each human biological materials.

The human biological materials must not be used and handled with extra-care before having received a validated certificate of analysis.

Are the donors tested for COVID?

All samples are collected in France. For the patient’s own safety, the surgery is performed only if a very recent COVID test has been validated by the clinical center and found negative. This procedure is in place in France since 2020.

Legal and Ethics

Where are sourced the samples?

Alphenyx only works with French hospitals and clinics and has established contracts with each of them. These contracts fully respect all applicable ethical and legal requirements. A rigorous procedure is therefore applied to guarantee donor's confidentiality.

What is the legal frame in France?

In France, Biomedical Research involving Human Being regulation is defined by the French Public Health Code.

Using human skin tissue for scientific purposes also requires the approval and authorization of the French Ethics Committee (Comité de Protection de Personnes or CPP) and the French Ministry of Research and Higher Education. Alphenyx has obtained all necessary authorizations issued by the competent authorities. Please see the ethics and regulatory section if you need more information.

All donors are adults (no under 18 years old donors). The samples collected for our general projects are clinical waste only from living donor. The tissue-donation of skin is based on volunteering by signing a free and informed consent form (ICF) before the surgery.

Is Alphenyx compliant with law outside France?

Alphenyx is respectful of Human Rights and Dignity of the Human Being, as defined by The Declaration of Helsinki (2013) and the human Tissue Act (2004).

Alphenyx complies with French law, which is one of the most restrictive in Europe. Therefore, we are compliant with the European Union Countries, Swiss and the UK laws. We are also compliant with FDA for the United States.

I’m a patient about to donate my discarded tissues for research use.

How does it work?

If your surgeon collaborates with us and your profile matches our studies requirements (which is not always the case), he/she will introduce you to our project (before the surgery).

You will be given an information letter explaining the purpose of your gift in details.

You will have the opportunity to ask questions and if you’re willing to donate your samples, you will sign two copies of our informed consent form (ICF). Our ICF have been approved by the CPP (the French national ethic committee). A copy of this signed ICF will be kept by your clinician in your medical records, the second copy is for you.

How is my privacy preserved?

Human samples donation is regulated by law. We have received all the authorizations issued by the Ministry of Research and respecting your rights is our priority.

Only your surgeon and the authorized medical personnel taking care of you have access to your identity. A rigorous procedure for double de-identification has been put in place. This procedure ensures that your identity will not be disclosed to anyone else. Thus, your identity will never appear in scientific reports or publications.

As part of your medical record, data is collected by your clinician. Only the information necessary for research will be transmitted to us in an coded document (which you can have acces to). For example, we don’t have access to your date of birth, but only to your age (year of birth).

This donation is therefore pseudonymized and any person trying to breach your identity will breach the law.

What happens if I gave my consent, but I have changed my mind?

You are completely free to accept or refuse this donation. You are also free to revoke your consent at any time ( for up to 10 years following the surgery date) without having to justify your reasons. If you revoke your consent, the biological samples relating to you will be immediately destroyed. Whatever your decision, it will have no impact on the quality of care you will receive. You can request additional information at any time.

What happens during the surgery?

Giving your samples for research won’t affect in any sort the surgical procedure.

Once the tissue is removed, a nurse will place your samples in the recipient provided, instead of placing it in the surgical waste to be incinerated.

Obviously, no additional skin (nor fat) tissue will be taken. We are only asking your authorization to use your surgical skin waste that your surgeon removes as part of your treatment, for research purposes.

Why is it important to donate my discarded tissues for research?

In four words: to reduce animal testing.

Any new drugs, cosmetics, sun creams, food additives or even pesticides in contact with Humans must undergo very strict testing to evaluate first of all their toxicity (or better their lack of toxicity). Their efficacy must also be proved to obtain an approval for human consumption.

Until very recently, the tests involved the sacrifice of hundreds of animals. For animal welfare, alternative techniques are being developed from donated human tissue.

In addition, the results obtained using animals are unreliable. It is not known whether tests performed on animals can formally predict potentially dangerous effects in humans. Thus, the use of donated human tissues, such as skin, instead of animal experiments, is necessary, because the results of these experiments will be more relevant to humans.

We are therefore working to propose and develop alternative methods to animals testing. The donation of tissue, by patients like you, will significantly contribute to a more ethic research and without animals.

How are my samples used?

Your samples will be transformed in in vitro models to be used for safety and efficacity testing of new molecules for human use, but also in fundamental research, like skin healing after a severe burn. (Please see our research program section).

Toxicity testing is crucial for our safety. Efficacity testing will depends of the “claim” of the products. An anti-inflammatory shall induce immunomodulatory molecules and decreases inflammation.

Essentially, your samples could be used in 3 different ways:

In permeation studies: these methods are really important because it allows to determine how much of the active molecule and excipients stay at the surface of the skin, are present in the different skin layers, or even go into your blood.
In tissue-culture: processed samples are placed in incubator at 37°C for topical application.
In cell culture: the different cells of the skin (keratinocyes, melanocytes, sebocytes, fibroblasts…) can be isolated from your discarded tissues to test the effects of a molecule (toxicity and efficacy) on a specific cell population. The cells are cultured in an incubator at 37°C.

In which project exactly my samples have been/will be used?

We are involved in many projects with academic partners and private researchers. Therefore, it is impossible to list every project in which your samples could be used.

However, you have the right to know exactly what is done with your samples and data collected (DGRP law).

If you want to know exactly in which project your sample have been used, please contact your clinician, who will inform us while preserving your privacy. In this way, he/she will transmit our detailed answer to you.

Quality Standards

Are quality standards defined?

As scientists ourselves, our aim is to provide high quality human biological materials and services to guarantee experimental reliability.

We dedicate ourselves to our customers and research partners to offer them full satisfaction.

Our principles: reactivity, adaptability, and integrity.

Optimized logistics and partnerships have been developed with the clinicians and medical staff, but also transporters specialized in biological materials handling to guarantee samples quality.

Samples are collected in France only and right after the surgery. Our local tissue acquisition network allows for the rapid processing (within a couple of hour maximum) of samples ensuring the best tissue viability. These samples are thus mainly processed as “fresh materials supply”.

“frozen materials supply” can be sourced either from our local or distant networks (in France) with the same quality standards. Samples processing and freezing is done in less than 24h after surgical removal.

Documentation

Which documents are provided with the human biological materials?

Each human biological material is shipped with a Certificate of Analysis (HIV1&2, Hep B and Hep C), and a datasheet summarizing donor/materials specification.

For environmental reasons, MSDS (Material Safety DataSheet) will be provided once in pdf format by email. Updated MSDS will be sent when necessary.

Which donor information is provided with the human biological materials?

Donor information includes age, gender, ethnicity, BMI, smoker/non-smoker, known skin diseases and conditions, and ongoing treatment.

Ordering and Shipping procedure

How can I order a sample?

The easiest way is to send us an email or contact us here.

How fast is the delivery?

Shipments are available worldwide with variable delivery time depending on the location, providing that your country accepts UN3373 biological materials and UN1845 (dry ice) importation.

The parcels are shipped from our laboratory in Marseille to your site with DHL or Fedex (for a delivery the next day before 12 pm or at the “end of the day” depending on your location). This allows us to reach most of the European destinations and the US East Cost in less than 24 hours.

For a more dedicated and fastest shipping, our partners TMS (Transport Medical Services) or P&O Transport Express (biological material specialized transporters) will ensure the delivery at a guarantee timing. Depending on your location a delivery is possible in France before 9 am.

How are biological materials packaged for transport?

We comply with current regulation for Biological Substance, Category B class 6.2 and WHO recommendations.

The packaging follows the P650 standard (triple packaging with absorbent).

The external packaging mentions the label UN3373 and the requested quote “Biological Substance, Category B, for research use only”. The UN1845 label (dry ice) is mentioned when necessary.

Fresh biological materials are shipped in an isothermal box at 4°C with cold packs.

Frozen biological materials are shipped in an isothermal box at -80°C with dry ice.