Biopredic International - developer of biological tools including hepatocytes, Silensomes™, HepaRG®, HepaSH™, skin products & blood products - Distributed in the UK & Ireland by Caltag Medsystems
Biopredic
Since 1993, Biopredic International has been committed to supporting Life Science Research by developing and distributing biological tools. They assist both academia and industries in drug development, drug discovery, cosmetic and chemical fields.
Biopredic International delivers assay systems, tissues, cells, and reagents including:
- High quality primary hepatocytes (human and animal, fresh or cryopreserved), HepaRG® cell model, and other liver-derived products.
- Skin products (fresh or frozen), including human skin discs and skin sheets (full thickness & dermatomed), skin cells, and subcellular fractions.
- Blood products, including whole blood, serum, plasma, etc.
- and other products such as biofluids and non-standard human and animal tissues.
The applications of Biopredic's products include toxicology, genotoxicity, metabolism, passage, bioanalysis, and transporter analysis.
Biopredic International is the exclusive worldwide licensor of HepaRG®, the human hepatic cell line patented by the French National Institute of Health and Medical Research.
See the Products Available:
Liver Products:
Skin Products:
Blood Products:
Other Products:
Liver Products
Hepatocytes
Primary hepatocytes are widely used as the gold-standard in-vitro liver model for biological, pharmacological, and toxicological studies in drug discovery and development.
Biopredic International provides a wide range of high quality fresh and cryopreserved hepatocytes, obtained from human and several animal species, to meet the specific needs of customers in view of many in-vitro applications.
Key advantages of hepatocytes produced at Biopredic International:
- A regular supply of fresh human and animal primary hepatocytes, i.e. 2 isolations per week from multiple species
- A wide range of fresh and cryopreserved hepatocytes, offering flexible choices
- Larger batch sizes of cryopreserved hepatocytes and the possibility to scale up (i.e. pooled donors)
- Pre-qualified cryopreserved human and animal hepatocytes allowing in-vitro protocols to meet your specific application requirements
- Full characterisation data available for each product lot, including Phase I /II drug-metabolising enzyme activities
- A complete Certificate of Analysis available for all products, including donor information, quality control values and specifications, as well as serological and sterility results
- Custom preparations according to your specifications.
Read more about Fresh Hepatocytes
HepaRG®
Biopredic have an exclusive license to manufacture HepaRG® hepatocytes, cells which have the unique properties of maintaining hepatocyte functions and are also able to carry out the complete replicative cycle of the Hepatitis B Virus, meaning they can be used in toxicology studies as an alternative to primary human hepatocytes.
HepaRG® is a reliable, robust, and well published human hepatic cell line used in an ever-growing range of applications.
Advantages of HepaRG®:
- The capacity to produce early hepatic progenitor cells as well as completely mature human hepatocytes.
- A morphology and metabolic capacity similar to human primary hepatocytes.
- The first human hepatic cell line to express main CYPs, functional nuclear receptors and major sinusoidal and canalicular hepatic drug transporters.
- Overcomes limited availability of liver tissue.
- Excellent batch-batch reproducibility and sub-cultures.
- CYP activities and expression of canalicular drug transporters can be increased by classical inducers.
- A robust cell-based system to evaluate metabolism of test compounds.
- A suitable model for high throughput screening of chemicals.
- A unique and exclusive model for in vitro pharmacological and toxicological studies.
- Can support the complete replicative cycle of HBV.
- Available as ready-to-use differentiated HepaRG® cells or as undifferentiated HepaRG® cells, the cell line that can be subcultured in-house.
- Usable and stable for up to 4 weeks once differentiation is achieved, ideal for long-term studies.
Applications of HepaRG®:
In-Vitro ADME
Innovative Modes of Culture
Infectious Diseases
Hepatotoxicity Screening and Mechanistic Testing
See all HepaRG® Medium & Supplements
HepaSH™
Biopredic was aware of the demand in the scientific community for a HepaRG®-similar model from another donor and have worked hard in recent years to develop a hepatic model that can complement HepaRG®.
Now, Biopredic is delighted to unveil the latest addition to its portfolio: HepaSH™. As a continuation of the HepaRG® model, HepaSH™ sustainable human hepatocytes from multiple donors represent the next evolution in liver research. Biopredic is confident that this model will be just as efficient as HepaRG®.
Other Liver Derived Products
Biopredic provides human and animal liver derived fractions and other hepatic cells.
Silensomes™: Quantifying the Contribution of CYP Enzymes in Drug Metabolism
Silensomes™ are human pooled liver microsomes in which one specific CYP has been chemically knocked out. Silensomes™ are a single unique and representative model, capable of directly quantifying and predicting the contribution of CYP enzymes in drug metabolism.
Drug-drug interaction can significantly impact drug safety and efficacy. Prediction of this risk of drug-drug interactions is a requisite in the development of a new drug candidate and the submission of the registration dossier. In-vitro identification and measurement of the contribution of the major cytochrome P450 enzymes involved in the human metabolism of a new drug candidate, also called “CYP phenotyping”, helps predict the impact of co-administered drug(s) (perpetrator(s)) on the pharmacokinetics of the new chemical entity (victim).
Until now, a battery of in-vitro tests recommended by the regulatory agencies (EMA/FDA) is required for this CYP phenotyping assay. These tests (correlation analysis, antibody or chemical inhibition and metabolism by recombinant human enzymes) have a number of disadvantages:
- No direct quantitative measurement of the contribution of each CYP in the metabolism of a drug (correlation analysis)
- Model is not fully representative of the liver enzyme profile (e.g. human recombinant CYP450)
- Lack of specificity (e.g. anti-CYP antibodies and chemical inhibitors)
To overcome the disadvantages of the current methodologies, Biopredic International, in collaboration with Servier Laboratories, has developed a patented new in-vitro drug development model.
Silensomes™ are validated human pooled liver microsomes (HLMs) chemically and irreversibly inactivated for one specific CYP using mechanism-based inhibitors (MBI).
Each Silensomes™ is available as ready-to-use HLMs chemically knocked-out for one specific CYP activity (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4) with each showing high specificity and efficiency of their targeted CYP inhibition (>80%), and only minor impact (<20%)
Key Advantages of Silensomes™:
Silensomes™: the model of choice for determination of the CYP contribution all along the development plan of a new chemical entity.
- Irreversibly inhibited CYPs
- For initial rate conditions
- For saturating conditions
- One single model for CYP phenotyping assays, instead of a battery of in-vitro tests
- Quantitative: the true contribution of the CYP450 in the metabolism of the compound can be measured
- A powerful model with an excellent specificity, potency, stability, and predictability to ensure reliable extrapolation of the drug-drug interaction risk
- More representative of in vivo situation, using human liver microsomes rather than recombinant enzymes isolated from non-mammalian cells
Silensomes™ are available for compound screening purposes and for regulatory validation.
Find out more about Silensomes™
Skin Products
Skin Discs & Sheets
Biopredic International is a major worldwide supplier of human and animal skin products, which can be used for several applications, including compound penetration, skin irritation, toxicology e.g. genotoxicity and sensitisation, metabolism, primary cell isolation, and more.
Biopredic International provides full-thickness and dermatomed skin, available as sheets or discs of different diameters, with or without stretch marks.
For dermatomed skin samples, part of the dermis is removed. Two ranges of skin thicknesses are available (200-400, OECD 428 compliant thickness, and 400-700µm). Other thicknesses can also be available upon request.
Key features of all human skin samples:
- A Certificate of Analysis is provided, showing information on the patient such as sample photos, age, sex, body mass index (BMI), ethnicity, possible disease states, living habits etc. Please click the links below for examples of the data received in Certificates of Analysis:
- Customised preparations are available on demand (specific shape, thickness for dermatomed skin, use of customer medium for shipment from Biopredic to your premises)
- Specific patient characteristics such as (but not limited to) the presence or absence of stretch marks, phototype, age, sex, ethnicity, Body Mass Index (BMI) can be requested.
- Tested negative for HIV1/2, HBV, HCV
- Delivered fresh or frozen:
- Fresh skin samples are shipped at 4°C on gauze soaked with a special medium or immersed in medium which maintains the viability and integrity of the skin during shipment. Fresh samples are shipped within 24 to 48h after the surgery.
- Frozen skins are shipped in dry ice.
- Can also be fixed and embedded: FFPE, OCT or following your specific protocol.
Human skin samples are collected from patients who have undergone cosmetic surgery.
The collection, processing and sales to Research Bodies comply with the French Law and ethical principles. Biopredic International holds a permit (AC-2013-1754) which has been granted by the French Ministry of Higher Education and Research.
The anonymity of patients is maintained, and patients sign an informed consent form before donating their samples.
Key features of animal skin samples:
- Sanitary controls are documented by animal provider’s health certificates, ensuring that animal was sheltered in an authorised breeding facility.
- Skin-derived products are collected from several animal species.
- Tissue quality is documented via macroscopic parameters: control of presence of scars, pen marks, cysts, moles.
- The dermatomed thickness is also measured.
- All skin-derived products are available as fresh, frozen or fixed, in sheets or disks.
- Fresh skin is delivered in culture medium (Biopredic’s or the customers’)
Other Skin Products
Biopredic International are also able to provide human and animal skin fractions as well as non-standard skin samples.
Contact us about Animal Skin Samples
Skin Cells
Key features of human skin cells from Biopredic International:
- Isolated from different locations of adult skin
- Single donors and pool of donors (3 donors minimum)
- Information regarding gender, age and BMI are provided
- Special requests can include the availability of donor matched sets of dermal cells
- All the cells are negative for HIV-1, HBV, HCV, mycoplasma, bacteria, yeast and fungi
- Possibility to test and/or reserve batches
- Available as cryopreserved cells – cryopreservation at passage 1 (5.105 cells/vial) for Keratinocytes and passage 2 (5.105 cells/vial) for Fibroblasts
- Controls performed on keratinocytes include morphology and cell density, viability, proliferation and clonogenicity.
- Controls performed on fibroblasts include morphology and cell density, viability and proliferation
- For culture medium, controls include physicochemical and microbiological specifications.
Blood Products
Biopredic International provides many different animal and human blood components for research needs for pharmaceutical and biotechnology companies as well as academic research laboratories.
Biopredic International collects and processes blood specimens according to their standard collection methods and according to customers’ specifications.
Human and animal whole blood, plasma and serum can be supplied as single or a pool of healthy donors. All donors of blood and blood derivatives are tested for HBsAg, HIV1/2 and HCV. Other serological tests can be performed upon request.
All animal biological materials are obtained from licensed facilities. Whole blood is collected from healthy laboratory animals that were maintained under controlled conditions. A health certificate is delivered by a veterinarian ensuring that the animals were healthy at the collection time.
Advantages of Biopredic International blood products:
- Available as fresh or frozen
- Wide range of anticoagulants
- Information regarding gender and age
- Fresh whole blood is collected and shipped the same day
- Fresh whole blood delivered within 24-72 h for human donors, after the blood collection, depending on collecting site location and delivery address
- Fresh whole blood volume available according to customers’ needs
- Frozen serum and plasma available in standard volume sizes
- Single donor or pooled donors / animals (3 minimum)
- Batch reservation available on request
Whole blood
Whole Blood is collected into a sterile blood collection bag or tube containing the anticoagulant for whole blood and plasma or without anticoagulant for serum.
Plasma
Plasma is the yellow liquid component of blood obtained by centrifugation of whole blood collected with anticoagulant. The most important elements in plasma include proteins (i.e. albumin, globulins, and fibrinogen), glucose, clotting factors, and hormones.
Serum
Serum is the liquid component of blood obtained after blood clotting. The serum is prepared by centrifugation to remove the clot.
Blood-Isolated Cells
Biopredic provides a selection of blood-isolated cells such as PBMCs or monocytes, from humans or animals.
To thaw frozen plasma and serum, place the container in a water bath at +37°C and periodically agitate the bottle or the tube during the thawing process to resuspend the viscous solutes and to avoid precipitation. Once the plasma or the serum is thawed, it should be used promptly or divided into single-use aliquots and frozen again.
The thawed plasma and serum may be stored refrigerated at temperatures between +2°C and +8°C for a maximum of one week.
These products are for in vitro and research use only. They are not intended for any other use.
Cell Culture Reagents
To complement their core liver & skin products, Biopredic International has a range of media and additives for the culture of liver and skin cells.
Biofluids
Human biofluids are drawn from healthy donors, who have been tested for HBV, HIV1/2 and HCV.
All animal biological materials are obtained from licensed facilities. Fluids are collected from healthy adult laboratory animals that were maintained under controlled conditions. A health certificate is delivered by a veterinarian ensuring that the donor animals were healthy at the time of collection.
Fluid products are stable when stored frozen and protected from the light until they are used.
These products are for in vitro and research use only. They are not intended for any other use.
Advantages of Biopredic International biofluids:
- Information provided regarding gender and age
- Frozen fluids available in different volume sizes depending on products
- Single donor/animal or pooled donors/animals (3 minimum)
- Batch reservation available on request
Custom Manufactured Biofluids
Biopredic International can also provide human and animal biofluids according to specific customer needs in terms of donor and/or process specifications such as (but not limited to):
- Specific process
- Specific volume
- Specific age and sex of donors/animals in single or pooled products
- Specific human donor characteristics regarding pathology, smoking, drug treatment, etc.
- Specific species and animal genus
- Number of donors in pooled products
Other Tissue
Biopredic are also able to provide a selection of non-standard human and animal tissues.