urosphere
Biobank
Privately owned biobank for urogenital sphere with ISO 9001 and ISO 20387 certifications.
Unique Urogenital cancers Biobank
The Urosphere Biobank manages and organizes human tissues and cells of human and animal origin for internal and external customers. The Biobank’s missions are as follows:
- Manage the collection network and centralize the receipt of biological resources (biological materials and associated data) to ensure scientific, ethical and regulatory traceability.
- Ensure that biological resources are properly and securely stored, so that they can be used for their full potential.
All these activities are carried out within the framework of current legislation, laboratory instructions, and applicable ethical and normative rules, ensuring traceability at every stage. Biobank members are bound by the principles of confidentiality and impartiality. They ensure the confidentiality of projects and do not under any circumstances communicate about collaborations or partnerships without his agreement.
Biological resources received by the Biobank come from:
- Sampling centers (e.g. French hospitals, clinics),
o Healthy tissue
o Tumor tissue
- Urosphere’s in-house R&D or from its academic or commercial partners,
o PDX
o Organoids
o Cancer cell lines
Urosphere’s Biobank organization
Sampling
The samples received at our premises all come from sampling centers with which Urosphere collaborates. These are all subject to the regulations in force concerning the taking of samples from human beings, which we endeavor to comply with, in particular the General Data Protection Regulation (RGPD) of the French Data Protection Authority (CNIL).
Transport
All transports are performed as fast as possible (under 24h) in the correct conditions according to inteded use (transport solution, controlled temperature). It’s also made in the respect of current regulations (e.g.IATA, ADR) by using triple packaging, correcte identification of biological risks.
Reception
The various samples received at Urosphere pass through the members of the biobank, who check and certify that the samples have been received in good condition. The control at reception is carried out based on the following criteria :
- Matching of pseudonymized information between sample and sample identification sheet
- Sample identification sheet correctly completed
- Containers are airtight and undamaged
- Serological safety of samples
- Sample transport conditions
- The nature of the sample
- Sample packaging
A sample is always accompanied by documentation containing the various associated data. Analogous to the verification of the physical sample, a check of the expected documents is carried out. These are listed below:
- sample identification sheet,
- patient file,
- post-surgery clinical data (optional).
Database
Data associated with incoming samples is pseudonymized by the sampling centers and undergoes additional internal coding on receipt. The expected associated data are clinical data associated to the patient (medical history, treatments undergone, anatomopathological results) or data linked to the characterization of the model received (PDX, Organoid, LCC).
All this data is stored in the MBioLIMS (Modul-Bio®) biological resource management software, ensuring continuous traceability of samples and rigorous collection of the various associated data.
Finally, quality controls are carried out monthly to check the accuracy of the information entered into the database by operators, and annually to ensure data continuity.
Processing
Samples stored by the Biobank can have different use for :
- Studies (Services) or for model development (Innovation),
- Medium long term storage at low or room temperature (cryopreservation, formol fixation) for deferred use or to supply an external customer.
One of them is the innovation aspect with the development of new model of PDX or Organoid with it’s characterization data. Those sample characterized are stored in the Biobank and can be use in pharmacologicals studies (Services) for exemple. In other hand, we have also the valorisation of the biological ressources linked to its activitiy, so if an external sponsor have needs in biological ressources, he can contact Urosphere for samples providing.
Storage methods
The methods used and the models stored are based on the state-of-the-art or validated internally as part of in-house studies. These are set up within Urosphere according to the fate and type of biological resource:
- Preservation in the presence of cryoprotectants (LN2),
- Paraffin preservation blocks and slides (RT),
- OCT preservation (-80°C),
- Dry preservation (-80°C or LN2).
Premises and equipment
A cryogenic room is available for the use of liquid nitrogen, enabling biological resources to be stored at -196°C. Other available equipment enables biological resources to be stored under controlled conditions ranging from +4°C to -80°C, and blocks and slides to be stored under controlled conditions.
The different temperature levels are organized in such a way as to ensure the safety of the samples:
- The temperature of storage chambers is monitored 24/24h, and staff are on call 7/7d,
- Two independent systems enable alarms to be reported in the event of a breakdown,
- Back-up chambers at +4°C (+/- 2°C), -25°C (+/- 5°C) and -80°C (+/- 10°C) are always available in case of breakdown,
- Access to the premises is controlled by badge.
MAD or Cession Process
Our Services, platform & Innovation
Urosphere’s experimental platform consists of both in vivo and in vitro pharmacological assays. We also provide access to a unique biobank of PDX preclinical models from urogenital cancers.
Finally, Urophere offers consultancy services for the preclinical development of your compounds.
Urosphere Services
Urosphere offers a range of services based on our innovative experimental models.
Urosphere Innovation
Development of customized models Codevelopment of therapeutic compounds Licensing.
Urosphere Platform
An optimized platform and a certified quality level for preclinical R&D services and innovation.