Home Page > Suppliers > Biopredic
Biopredic

Welcome to Biopredic - distributed in the UK by Caltag Medsystems

Biopredic provide Human and Animal Primary Cells, Cell Lines and Tissues for Research, Drug Discovery, Drug Development, Pharmacology and Toxicology:

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 is 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 has developed in collaboration with Servier Laboratories 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 coumpound 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, using human liver microsomes rather than recombinant enzymes isolated from non-mammalian cells

Silensomes are available for compound screening purposes and also for regulatory validation.

Fresh and Frozen Human Skin

Biopredic International is a major worldwide supplier of human and animal skin products, which can be used for several applications such as:

  • Compound penetration
  • Skin irritation
  • Toxicology e.g. genotoxicity and sensitization
  • Metabolism
  • Primary cell isolation...

Biopredic International provides different types of human skin samples:

  • full-thickness and dermatomed abdominal and breast skin, provided as sheets or discs of different diameters (from 5 to 40 mm), with or without stretch marks.

For dermatomed skin samples, part of the dermis is removed and the thickness of the skin ranges from 300 to 700 µm.

Biopredic also provides Stratum Corneum prepared from different anatomical sites:

  • scalp with or without hair follicles
  • upper and lower eye lid
  • arm
  • thigh
  • back

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.
  • Available with one or two freezing cycles
  • 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 which maintains the viability and integrity of the skin during shipment. Fresh samples can be shipped within the same day as 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.

Fresh Human Skin Email Alert Service

We receive lists on Friday afternoons, for surgeries to be performed the following week. Our Fresh skin email alert service notifies interested parties of the intended operation dates and skin sites for the surgeries allowing customers to reserve skin.To join the fresh skin alert service, or for further information, please email us.

Human Primary Cells

Dermal Fibroblasts

Dermal fibroblasts are an essential component of the dermis; they not only produce and organise the extracellular matrix of the dermis but they also communicate with each other and with other cell types, playing a crucial role in regulating skin physiology. Like other cells producing connective tissue, fibroblasts are derived from primitive mesenchyme's.

Human dermal fibroblasts are extensively used for a wide range of cellular and molecular studies: ECM protein analysis, wound healing, skin therapy/models, cosmetic testing, collagen metabolism, etc. They are also used for toxicology, pharmacology and drug development.

Key features of human dermal fibroblasts from Biopredic International:

  • Isolated from different locations of adult skin: abdominal, face and breast
  • Single donors and pooled donors (3 donors minimum)
  • Information regarding gender, age and BMI are provided
  • Special requests can include the availability of donor matched sets of dermal fibroblasts, keratinocytes and preadipocytes
  • 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 2 (5.105 cells/vial)
  • Controls performed on fibroblasts include morphology and cell density, viability and proliferation
  • For culture medium, controls include physicochemistry and microbiological specifications.

It is recommended to use fibroblast medium that has been developed for the in-vitro cultivation of adult human fibroblasts by Biopredic International. It contains a basal medium that is supplemented with mixtures containing serum and antibiotics.

Human Keratinocytes

Human keratinocytes are an essential component of the epidermis. They form a barrier against external damage including viruses, bacteria, UV radiation, and all potential environmental attacks. They have a major role in the inflammatory response.

Human keratinocytes are used for a wide range of cellular and molecular studies: skin therapy/models, cosmetic testing, etc. They are also used for toxicology, pharmacology and drug development.

Human keratinocytes are isolated from adult human skin and cultured over one to three passages and then frozen.

Key features of human keratinocytes from Biopredic International:

  • Isolated from different locations of adult skin: abdominal, face and breast
  • 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 keratinocytes, dermal fibroblasts, and preadipocytes
  • 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)
  • Controls performed on keratinocytes include morphology and cell density, viability, proliferation and clonogenicity.

Animal Skin

Fresh or frozen animal skin from the following species is available: rat, mouse, beagle dog, cynomolgus monkey.

  • Sanitary controls are documented by animal provider's health certificates, insuring that animal was sheltered in duly 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 fresh or frozen, in sheets or disks.
    • Fresh skin is delivered in culture medium (Biopredic's or the customers')
    • Frozen sample: skin can be delivered with one or two freezing cycles, depending on species and tissue availability.

Animal skin is used for penetration, toxicological and pharmacological studies or cell isolation.

Please contact us for further information.

Animal Primary Cells

Animal Primary Cells Include: Rat, Mouse, Monkey and Dog Cells.

Hepatocyte Cell Line: 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 fresh hepatocytes.

HepaRG is a reliable, robust and well published human hepatic cell line used in an ever-growing range of applications.

HepaRG has many key advantages, including:

  • 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 hepatoma 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.
  • Usable and stable for at least 4 weeks once differentiation is achieved, ideal for long-term studies.
  • Can support the complete replicative cycle of HBV.
  • Please click here to view the HepaRG cells that are available and here to view the HepaRG medium and additives.

Applications

Click the following links to view in detail the different applications:

Contact us for HepaRG purchasing options: +44 (0)1280 827460 or email office@caltagmedsystems.co.uk

Fresh Human 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 our 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 (rat, mouse, dog and monkey)
  • 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-metabolizing enzyme activities
  • A professional storage and delivery of fresh plated hepatocytes with Biopredic's patent-pending Sealovac Packaging Technology (guaranteed for a maximum of 3 days)
  • 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.

Applications

In suspension: clearance, uptake & metabolism studies

Monolayer: Metabolism, toxicology, infection, DDI & Transport (sandwich culture)

Induced Monolayer: Induction-cytochrome levels will alter when induced

Fresh Hepatocytes Email Alert Service

Fresh hepatocytes are available. To receive dates of intended surgeries and to reserve hepatocytes, please sign up here.

Fresh Animal Hepatocytes

Biopredic International provides a wide range of fresh animal hepatocytes obtained from a variety of species: rat, mouse, hamster, rabbit, cynomolgus monkey, dog, minipig and other species (available on demand).

Fresh animal hepatocytes can be prepared from either single animal liver donor (such as mouse, rat, dog, monkey, rabbit or hamster) or pooled from several animal donors (mouse, rat or rabbit) according to our production schedule.

All rodent hepatocytes are isolated from animals housed in our animal facility which is managed in strict compliance with the Directive 2010/63/EU of the European Parliament and of the Council.

Hepatocytes of other animal species are isolated from the liver tissues collected following approved protocols and respecting all ethical and legal requirements.

Cryopreserved Hepatocytes

Biopredic International has more than 20 years in-house experience of cryopreserving human and animal hepatocytes.

Biopredic offers hepatocytes in suspension (Grade S) or plateable.

Plateable hepatocytes are offered in different grades:

  • Cryoplateable Human Hepatocytes (Grade P)
  • Cryoplateable and inducible Human Hepatocytes (Grade I)
  • Cryoplateable & easy-to-use Hepatocytes (Grade NS for “no-spin required”)
  • Cryoplateable & sandwich culture hepatocytes

Biopredic International is also the sole European distributor of cryopreserved hepatocytes produced by Triangle Research Labs (TRL), offering a wider supply of human hepatocytes.

Every lot of human cryopreserved hepatocytes from TRL is fully characterized for viability/stability, cell yield, attachment efficiency (and optimal seeding density), monolayer confluency, Phase I and II drug enzyme activities, induction potential, transporter activity, and 14 relevant SNPs.

Cell Fractions

Cell Fractions (such as Microsomes, Cytosols and S9 Fractions) including: Human Cell Fractions, Mouse Cell Fractions, Rat Cell Fractions, Dog, Monkey and Other Animals.

Skin fractions include human and animal (rat, minipig, mouse, etc.) cryopreserved cytosols, S9 fractions, homogenates and microsomes.

  • All human subcellular fractions products are delivered with a Certificate of Analysis showing information on the patient such as age, sex, ethnicity, etc.
  • All human samples are tested HBV, HBC, HIV-1 and HIV-2 negative.
  • All animal products are delivered with a Certificate of Analysis giving information on the animal(s) specie, strain, age, sex, age, weight, identification number, etc.

Subcellular fraction isolation procedure

  1. Homogenisation of tissue
  2. Sonication
  3. Centrifugation
  4. 2nd Centrifugation
  5. Pellet recovery in special medium
  6. Storage at -80°C
  7. Controls

Fraction production process:

Fraction production process

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 our 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 donors.

Human whole blood, human plasma and human serum are drawn from 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 h-72 h for human and animal samples, 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 (10 ml for animal samples and 10, 20, 50 and 100 ml for human samples)
  • Single donor or pooled donors / animals (3 minimum)
  • Batch reservation available on request

Processes for blood products

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.

Whole blood can be separated into plasma, serum and globular fractions.

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 is the liquid component of blood obtained after blood clotting. The serum is prepared by centrifugation to remove the clot.

Human buffy coat is the fraction derived from a blood sample which contains a mix of platelets and leukocytes (which play a key role in immune reactions). This product is prepared by centrifugation of whole blood.

Globular fractions are the red blood cells whose primary function is to transport oxygen to body tissues via the blood stream. This component is prepared by centrifugation or sedimentation of whole blood to remove the majority of the plasma.

Lipoprotein fractions are plasma proteins, which play a significant role in the transport and metabolism of cholesterol. Lipoprotein fractions include HDL (high density lipoprotein), LDL (low density lipoprotein) and VLDL (very low density lipoprotein).

Use of blood products

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.

Body Fluids

Human fluids such as saliva, sputum, urine, gastric fluid, intestinal fluid, bile, milk and feces are drawn from healthy donors.

All donors of are 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.

Advantages of Biopredic International fluid products

  • Information provided regarding gender and age
  • Frozen fluids available in standard volume sizes depending on products
  • Single donor/animal or pooled donors/animals (3 minimum)
  • Batch reservation available on request

Custom manufactured fluid products

Biopredic International can also provide products 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

Storage of fluid products

Fluid products are stable when stored frozen and protected from the light until they are used.

The recommended storage temperature for saliva, gastric and intestinal fluid is -80°C.

The recommended storage temperature for urine, bile, milk and faeces are -20°C.

These products are for in-vitro and research use only. They are not intended for any other use.

Tissue Culture Media and Supplements

View the Inventory

If you are having difficulty downloading product data or require further information, please contact us.

Select:

  • Suppliers
  • Suppliers
  • Products