Fresh Hepatocytes
Freshly isolated hepatocytes are widely accepted as a superior in-vitro model for evaluating the in-vitro hepatic metabolism and toxicity of test compounds because they more closely reflect the in-vivo situation, when compared with other models.
Biopredic International has built up a well-organized supply network which guarantees the regular delivery of human liver resects (after partial hepatectomy or from human whole livers rejected for liver transplantation) and animal livers. High quality fresh human and animal hepatocytes are isolated and then fully characterized.
Fresh human hepatocytes products include
- Hepatocytes suspensions suitable for short-term metabolism studies (up to 4 hours) and
- Plated (monolayer) hepatocytes cultures for longer-term metabolism studies (up to 3 days).
Fresh human hepatocytes in suspension
In order to provide suspended human hepatocytes, freshly isolated hepatocytes from human liver tissue are rapidly suspended and preserved in Biopredic’s optimized hypothermic medium to maintain cell viability and functional activity during shipment period (up to 48hours).
Key features of human fresh hepatocytes in suspension
- Good availability of fresh cells with proprietary production process
- High quality product combined with optimized hypothermic shipping condition
- Stable and retained viability and expression level of metabolizing enzymes
- Greater flexibility to handle cells either in suspension or plated cell culture
- Characterization data available for each product batch sheet
- General patient information (age, gender, race, health conditions, serology)
Characterization for fresh human hepatocytes in suspension
Biopredic provides the following data for each lot of hepatocyte suspension:
- Viability after isolation and after cold shipping period, yield, plateability after cold storage period, morphology before and after shipment
- Phase I drug-metabolizing enzymes with a cocktail of probe substrates: CYP1A2/ 3A4/ 2B6/ 2D6/ 2C19
- Phase II drug-metabolizing enzymes: UGT1A1/ UGT1A6/ UGT1A9/ UGT2B15/ SULT1A1/ SULT1A3/ 4/ SULT1E1
- Serological and sterility control data
Shipment of fresh human hepatocytes in suspension
Freshly isolated hepatocytes are suspended in an optimized hypothermic medium and then aliquoted into cryovials containing at least 10 million cells per vial (1ml).
The cell suspension is shipped the same day of the preparation (or the following day) at hypothermic condition (2-8°C).
The viability, plateability and functionality of preserved cell suspension are well maintained for at least 48h at 4°C.
Fresh plated human hepatocytes
To provide adherent monolayer cultures, freshly isolated and viable cells are plated at a desired seeding density onto collagen-coated culture supports according to the customer’s request/ordering.
After overnight attachment, the seeding medium is replaced with either a short-term culture medium or long-term culture medium (Lanford et al., 1989) to produce short-term (≤ 3 days) or long-term hepatocytes (≤ 6 days) cultures in which cells retain a differentiated phenotype for at least 1 week.
Both freshly prepared short-term and long-term cultured hepatocytes contain all major phase I and phase II enzymes as well as the whole gene regulation pathway necessary to investigate the potentiality of drugs to induce phase I and phase II enzymes.
Key features of human fresh plated hepatocytes
- Multi-format plated cells and custom preparation available
- Greater viability and confluence of cells in monolayer
- High expression levels of major hepatic drug-metabolizing enzymes, co-factors and cell membrane receptors
- Greater flexibility for applications with either short or long-term cultures
- Optimized packaging and shipping conditions with Biopredi's patented technology - SEALOVAC
- Full characterization data available for each product batch sheet
- General patient information (age, gender, race, health conditions, serology)
Characterization of human fresh plated hepatocytes
Biopredic International provides the following data for each lot of plated hepatocytes:
- Cell viability and cell culture period after isolation and seeding
- Cell morphology and culture confluence by microphotography
- Phase I drug-metabolizing enzymes with a cocktail of probe substrates: CYP1A2/ 3A4/ 2B6/ 2D6/ 2C19)
- Phase II drug-metabolizing enzymes: UGT1A1/ UGT1A6/ UGT1A9/ UGT2B15/ SULT1A1/ SULT1A3/ 4/ SULT1E1
- Serological and sterility control data
Shipment of human fresh plated hepatocytes
Plated hepatocytes cultured into multi-well plates are firstly filled with either short-term or long-term culture medium (with or without Phenol red) according to customer’s specification/request.
The pre-filled plate is then packaged using Biopredic's patent-pending Sealovac™ Technology for the shipment at room temperature (18-30°C).
Cell quality and functional activity of packaged monolayer cells are well maintained for at least 48hours.
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.
Fresh animal hepatocytes products include
- Hepatocytes suspensions
- Plated (monolayer) hepatocytes cultures
Fresh Animal Hepatocytes in suspension
In order to provide animal hepatocytes in suspension, the freshly isolated cells are rapidly suspended and preserved in BPI’s optimized hypothermic medium able to maintain cell viability and functional activity during the shipment period (up to 48h).
Key features of fresh animal hepatocytes in suspension
- Good availability of fresh cells from multiple species thanks to our scheduled production
- Custom preparation available for both single donor and pooled cells
- Large pooled lot size allows to conduct multiple experiments from the same pool of donors.
- High quality product combined with optimized hypothermic shipping condition
- Stable and retained viability and expression level of metabolizing enzymes,
- Greater flexibility to handle cells either in suspension or plated cell culture
- Certificate of Analysis available for each batch
- Donor animal information (species, identification number, age, sex, serology)
Characterization for fresh animal hepatocytes, whether in suspension or plated
BPI provides the following data for each lot of hepatocyte suspension:
- Donor animal information (species, identification number, age, sex, serology)
- Viability, yield, plateability, morphology before and after shipment
- Phase I drug-metabolizing enzymes with either a cocktail of probe substrates or a specific probe susbstrate: CYP1A/ CYP2D/ CYP3A
- Phase II drug-metabolizing enzymes: UGT1A/ UGT2B/ SULT1A/SULT1E.
- Glucuronidation and sulfation activity of acetaminophen
- Sterility control data
Shipment of fresh animal hepatocytes in suspension
Freshly isolated hepatocytes are suspended in an optimized hypothermic medium and then aliquoted into cryovial containing at least 10 million cells per vial (1ml). The cell suspension is shipped at hypothermic condition (2-8°C). The viability, plateability and functionality of preserved cell suspension are well maintained for at least 48h at 4°C.
- Fresh rat or mouse hepatocytes in suspension are isolated and shipped the same day.
- Fresh suspended hepatocytes from other species are isolated and shipped either the same day or the following day according to the liver tissue availability
Fresh Plated Animal Hepatocytes
To provide plated animal hepatocyte cultures, the freshly isolated and viable cells are plated at a desired seeding density onto collagen-coated culture surface according to the customer’s request/ordering.
After an appropriate period of cell attachment (from 4hours to overnight depending upon the species), the seeding medium is replaced with a short-term culture medium and then packaged for the shipment.
Fresh plated cultured hepatocytes contain all major phase I and phase II enzymes and can be used in a wide range of in-vitro applications.
Key features of fresh plated animal hepatocytes
- Multi-format plated cells and custom preparation available
- Greater viability and confluence of cells in monolayer
- High expression levels of major hepatic drug-metabolizing enzymes, co-factors and cell membrane receptors
- Greater flexibility for applications with cells derived from multiple species, either single or pooled donor animals
- Optimized packaging and shipping conditions thanks to Biopredic's patent technology SEALOVAC™
- Certificate of Analysis available for each batch
- Donor animal information available (species, identification number, age, sex, serology)
Characterization for fresh plated animal hepatocytes
Characterization as for fresh animal hepatocytes in suspension.
Shipment of fresh plated animal hepatocytes
Like for human plated hepatocytes, animal plated hepatocytes cultured into multi-well plates are firstly filled with short-term medium (with or without Phenol red) according to customer’s specification/request. The pre-filled plate is then packaged using Biopredic’s patent-pending Sealovac™ Technology for the shipment at room temperature (18-30°C). Both the quality and the functional activity of packaged monolayer cells are well maintained for at least 24h.
- Fresh plated rat or mouse hepatocytes are isolated, plated and shipped the same day
- Fresh plated hepatocytes from other species are isolated and plated the same day, but shipped the following day
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.