PeploBio
UK-registered contract research organisation and diagnostic laboratory providing laboratory testing, assay development and validation, flow cytometry, genomics, biospecimen sourcing and regulatory consulting. Operates an ISO 15189–accredited laboratory, offers clinical trial testing and sample logistics, supports regulatory pathways (UKCA, IVDR, CTDA, FDA), and provides patient-facing kit activation and consent workflows for screening samples.
Industries
Nr. of Employees
small (1-50)
PeploBio
Stoughton, Onslow Village, England, United Kingdom
Services
Laboratory quantitative mass spectrometry assays to identify and quantify circulating peptide therapeutics in plasma and whole blood for PK, exposure and adherence studies.
Flow cytometry services including immunophenotyping panels, receptor occupancy, absolute counts, cell cycle, apoptosis assays and cell sorting for research and clinical studies.
End-to-end custom assay development and formal validation for RUO, LDT, IVD and companion diagnostics across molecular and immunoassay platforms.
Project management, study design support, biospecimen management, assay deployment and data reporting to integrate biomarker testing into clinical studies.
Sourcing of clinical biospecimens from collection sites and biobanks with customised collection kits and temperature-controlled international shipping.
Regulatory strategy, clinical evaluation planning, technical file preparation and submission support for UKCA, IVDR, CTDA and FDA pathways.
Laboratory quantitative mass spectrometry assays to identify and quantify circulating peptide therapeutics in plasma and whole blood for PK, exposure and adherence studies.
Flow cytometry services including immunophenotyping panels, receptor occupancy, absolute counts, cell cycle, apoptosis assays and cell sorting for research and clinical studies.
End-to-end custom assay development and formal validation for RUO, LDT, IVD and companion diagnostics across molecular and immunoassay platforms.
Project management, study design support, biospecimen management, assay deployment and data reporting to integrate biomarker testing into clinical studies.
Sourcing of clinical biospecimens from collection sites and biobanks with customised collection kits and temperature-controlled international shipping.
Regulatory strategy, clinical evaluation planning, technical file preparation and submission support for UKCA, IVDR, CTDA and FDA pathways.
Expertise Areas
- Clinical trial testing and biomarker integration
- Flow cytometry and quantitative cytometry
- Assay development for molecular and immunoassay platforms
- Analytical and clinical assay validation for diagnostics
Key Technologies
- High-resolution accurate-mass mass spectrometry
- Multicolour flow cytometry
- Quantitative PCR (qPCR/RT-qPCR)
- Sanger sequencing
News & Updates
Article discussing FDA LDT regulatory changes and phased compliance approach.
Guide on IVDR performance evaluation requirements and implementation.
Update on IVDR transition timelines and implications for manufacturers.
Recognition by Life Sciences Review listing PeploBio among the top clinical laboratory services companies in the UK.
Article discussing FDA LDT regulatory changes and phased compliance approach.
Guide on IVDR performance evaluation requirements and implementation.
Update on IVDR transition timelines and implications for manufacturers.
Recognition by Life Sciences Review listing PeploBio among the top clinical laboratory services companies in the UK.