DMPK Transporter Assay Service
GLP-compliant ABC transporter inhibition assay service for IND-enabling DMPK packages — IC50 determination for BSEP, BCRP, P-gp and MRP family transporters against FDA, EMA and ICH M12 guidance. Performed by Ciptec (Cell4Pharma, Belgium). SeamlessBio is the exclusive DACH distributor.
Available Assay Services
BSEP Inhibition Assay
Bile Salt Export Pump — critical for hepatotoxicity and drug-induced liver injury (DILI) risk assessment. IC50 determination with ATP-dependent transport measurement. FDA-required for hepatically eliminated compounds.
BCRP Inhibition Assay
Breast Cancer Resistance Protein (ABCG2). IC50 determination for drug-drug interaction risk. Required for compounds that are BCRP substrates or potential inhibitors.
P-gp Inhibition Assay
P-glycoprotein (MDR1/ABCB1) — the primary efflux transporter. IC50 determination for intestinal absorption, CNS penetration and drug-drug interaction assessment. EMA/FDA required.
MRP1–5, MRP8 Panel
Multidrug Resistance-associated Protein family. Comprehensive MRP inhibition panel for full regulatory transporter profiling of drug candidates.
IND-Enabling Package
Complete regulatory transporter panel — all FDA/EMA-required transporters in one package. Includes full study report suitable for IND submission. ICH M12 compliant.
Custom Transporter Panel
Custom combination of transporters for specific compound profiles or regulatory market requirements. Contact us with your transporter targets and regulatory territory.
Why ABC Transporter Assays Are Required
FDA and EMA guidance (ICH M12, 2023) requires ABC transporter inhibition data for IND submissions for all new drug candidates that are:
- Hepatically metabolised or eliminated
- Substrates or inhibitors of P-gp or BCRP
- Candidates with potential hepatotoxicity concerns (BSEP)
- Part of a drug-drug interaction risk assessment package
Missing transporter data is a common cause of IND/CTA delay. The Ciptec service provides study-ready data with full regulatory documentation in a single package.
| Transporter | Regulatory Requirement |
|---|---|
| P-gp (MDR1) | FDA + EMA — mandatory |
| BCRP (ABCG2) | FDA + EMA — mandatory |
| BSEP | FDA recommended; EMA expected for hepatic compounds |
| MRP2 | Context-dependent; hepatic elimination |
| MRP1, 3, 4 | ICH M12 comprehensive panel |
Frequently Asked Questions
What is the Ciptec DMPK service?
GLP-compliant ABC transporter inhibition assay service by Cell4Pharma (Belgium) — IC50 determination for drug candidates against BSEP, BCRP, P-gp and MRP family. Delivers IND-ready study reports for FDA and EMA submissions.
Is SeamlessBio the exclusive DACH distributor?
Yes — SeamlessBio is the exclusive DACH (Germany, Austria, Switzerland) distributor for Cell4Pharma vesicle kits and the Ciptec assay service. Contact info@seamlessbio.de for service enquiries and quotes.
How long does the assay service take?
Typical turnaround 4–8 weeks from sample receipt to final study report, depending on the transporter panel selected. Rush options may be available — contact us for timeline requirements.
Related Products
ABC Transporter Vesicle Kits
In-house vesicle kits for BSEP, BCRP, P-gp, MRP1–8 for own laboratory use.
BSA Fettsäurefrei
Required for DMPK protein binding assay buffers.
DMPK Application Guide
Protocol overview for ABC transporter inhibition assays.
Kontakt
Request service quote or discuss your DMPK package requirements.
Request DMPK Assay Service Quote
IND-enabling transporter panel — contact us with your compound, required transporters and regulatory territory.
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