DonorPlex™ Pooled Donor Human Hepatocytes

Using pooled donor human hepatocyte lots in your ADME studies that ensure robust and consistent results are of great importance. With our new proprietary algorithm, we are able to predict yield, viability, and functional phenotype of DonorPlex™ Primary Human Hepatocytes which in turn will support more consistent results in your ADME studies. What is more, with our large inventory of single donor human hepatocyte lots and this unique algorithm, we can also produce a variety of different phenotypes to fit your needs.

Dr. Maureen Bunger, former Product Manager for ADME-Tox Solutions at Lonza, introduces our new DonorPlex™ Pooled Human Hepatocytes as a valuable solution for pharma companies during the 2019 SLAS Conference.

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Pooling Process

We have optimized a robust manufacturing process to produce pooled donor human hepatocyte lots with little variability. Demonstrated in Figure 1, we show ability to reproducibly create a lot with the same phenotype on multiple different dates. The optimized manufacturing process also ensures each lot of pooled suspension hepatocytes meets stringent yield and viability specifications.

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Average Activity of Three Independent Lots with Identical Donor Composition

Three batches of 20 donors were pooled on three separate dates. Activity values are shown representing Lonza’s capability to reproduce pooled lots.

Predictable Activities for Customizing Pools

Large batches of hepatocytes from pooling donors together can supply research programs for many years. When a new batch of pooled donor human hepatocytes is needed, many researchers would like the new batch to be similar to the previous one.

We use a proprietary algorithm to predict final activity of a pooled donor batch prior to manufacture. Shown in Figure 2 are the results of the predicted activity of a 20-donor pool compared to the actual activity. This gives us the unique ability to work with customers to create lots with specific CYP activity, or produce lots with CYP levels that represent the average population.

With our optimized pooling procedure, we can provide our customers with a variety of pool demographics and sizes for their metabolism testing needs. With our predictive algorithm, we can also create customer-driven customizable pooled donor human hepatocyte lots to meet specific CYP activity requirements.

Predicted vs Actual Activity for 20-donor Pool

Predicted activities versus measured activities for eight CYP enzymes, general ECOD metabolism and ECOD phase II enzymes (UGT and SULT) when individual donors are pooled together.

DonorPlex™ Hepatocytes Specifications

Yield > 5x106 viable cells per vial
Customizable CYP, ECOD, and phase II ECOD metabolism activity, as measured by LCMS metabolite formation using model chemicals
OAT1B1/1B3, OCT1/2, and NCTP transporter activity in a facilitated active uptake study using model chemicals

DonorPlex™ pooled donor human hepatocytes portfolio

Pool Characteristics
10 donors, mixed gender
10 donors, all female
10 donors, all male
20 donors, mixed gender
20 donors, all female
20 donors, all male
50 donors, mixed gender

DonorPlex™ pooled donor suspension hepatocytes

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Human hepatocyte inventory

View donor information and select characteristics of currently available human hepatocyte lots. Table includes single donor and pooled donor lots in either suspension or plateable formats.

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Custom DonorPlex™ human hepatocytes request

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Start your path towards obtaining DonorPlex™ Hepatocytes customized for your specific needs.

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