Advance your liver modeling
Human Hepatocytes Production
ADME-Tox on scale
Why primary human hepatocytes are considered as the gold standard for hepatic in vitro culture models?
Produced by Preci, licensed by Biopredic International
Primary human hepatocytes are the cellular model used in drug discover programs to uncover the pharmacokinetics of a lead as early as possible. Not only they bring the full DMPK drug profile, however, also show dynamic behaviour of metabolic enzymes.
Robustness
Human hepatic cells may be used for
a wide experiment range as:
Representativity
Primary human hepatocytes are the only faithful liver model, which is validated on is validated on:
Hepatic clearance
Metabolism by CYP and other hepatic enzymes
Compound uptake
Drug-drug Interaction
Drug Induced Liver Damage HBV assays
Transporter expression
CYP activity
Drug response
HBV uptake
Scalability
Organization of efficient and ethical sample procurement guarantees and unique hepatocytes isolation approach guarantees
85%+ of post-thaw viability and high
abundance of the large plateable batches
Donor engagement reaching
200 annually
Cell yield at 20 million
cells/gram of tissue
Quality standard and assurance
Batch acceptance standards for DMPK use:
> 400 vials in a batch
> 85% viability
> HBV, HCV, HIV-free, microbiological and fungal sterility acc. to the standard-of-use
NUNC vials, suitable
for dispatch automation
Automation for vial
filling with <10% variability
Batch-to-batch variation factors and mitigation of those
Hepatocyte phenotypes
Induvidual recomendations for a batch
Metabolic parameters
CYP-based qualification
Hepatocyte plateability
Protein-based confluence assays and batch qualification
Counting errors
Independent batch release QC
Ethics
Preci LLC is committed to deliver the fully ethically sourced products of human origin. Our donor involvement is compliant with modern EU requirements, Human Tissue Act UK and US regulations.
You can validate the compliance by asking on hi@preci.care or by visiting our Scientist.com account.
The hepatocytes production with 30,000 vials produced annually
Production
two-step perfusion
Organization of the sample procurement network
Scalability:
3 central hospitals
20+ liver surgeons
Presence of the procurement team within the OR
Bioethics audit from largest law companies
Rejected transplant specimens:
Countrywide network
Ethical and respectful material
collection
Ex vivo perfusion
Quality control
Viability
CYP activity
Plateability
Genomics and Proteomics
Establishment of the facility
with 24/7 work schedule to ensure timely sample acceptance
Monolayer remains after
120 hours of cultivation
>75% viability upon thawing
>5 mln cells
formation of confluent monolayer within 24 hours with only 350k - 450k cells/well (24-well plate)
long-term (>120 hours) cultivation
Metabolic parameters are qualified based on literature-based average and standard population deviation.
Polymorphisms are detected by PCR
CYP2D6
CYP2C9
CYP2B7
CYP3A4
CYP3A(general)
UGT2B7
UGT1A9
UGT1A4
UGT1A6
Phase II (general)
Induction-qualified batches can be released on-demand.
Every batch is supplied with batch-specific medium and plasticware.
Batches over 1000 vials available
>75% viability upon thawing
>5 mln cells
available in 10-donor and 20-donor pools
Pre-qualified on CYP activity
Pooled hepatocytes production conducted by licensed party Biopredic International.
Pools are male/female balanced
Perfect for hepatic clearance assays