Biodistribution and Viral Shedding

A gloved hand interacts with the touchscreen of a QuantStudio 7 Flex machine, presumably used for scientific experiments in bioanalytical development. The screen displays an ongoing experiment with details such as the experiment name, time, and protocol information.

Pharmaron specializes in the development of complex bioanalytical methods for determining gene expression and vector presence within preclinical, clinical and cell and gene therapy studies. In addition to a traditional PK assessment, Pharmaron utilizes biodistribution data coupled with other preclinical safety endpoints, such as clinical pathology and histopathology, to evaluate tissue-specific detrimental effects in humans.

For viral vectors used in gene or gene modified cell therapies, Pharmaron develops shedding assays to characterize the release of the virus from an animal or treated human as a risk assessment. To best characterize the transcription and translation of a transgene, Pharmaron offers a variety of molecular and protein-based platforms to provide robust data for translatable safety and efficacy results supporting preclinical, clinical, long-term follow up and pharmacovigilance needs.

A gloved hand holding a laboratory pipette with multiple channels dispenses pink liquid into the wells of a microplate. The environment appears to be a lab setting, evident from the scientific equipment and precise handling, indicative of bioanalytical development in preclinical ADME studies.

Biodistribution Services

  • Species: rodents (transgenic, immune-deficient, healthy); large animals (rabbit, mini-pig, canine, NHP, immunosuppression regime required)
  • Route of administration: mimic clinical route
  • Determine levels of drug (virus, gene-modified cells) or transgene and its product in target and non-target tissues and cells
  • Determine successful transduction of target tissue or cells and level of drug present/expressed in non-target tissues
  • Generation of data to support first-in-human trial
  • Biodistribution samples: blood, plasma, CSF, various tissues
Scientists in protective gear, including face masks and blue gloves, use pipettes to transfer liquid samples into test tubes in a laboratory conducting preclinical ADME studies. Several boxes and containers are on the table, with blurred figures and lab equipment in the background.

Viral Shedding Services

  • Species: rodents (transgenic, immune-deficient, healthy); large animals (rabbit, mini-pig, canine, NHP, immunosuppression regime required)
  • Route of administration: mimic the clinical route
  • Determine secretion/excretion profile of virus/vector
  • Support post-dose monitoring for vector shedding with robust assays to mitigate safety and environmental concerns for replication-competent viral vectors
  • Data translated from non-clinical shedding studies to estimate likelihood and extent of shedding in humans and inform the clinical study design
  • Shedding samples: Serum, saliva, feces, urine, semen, nasal secretions, tears
  • Viral shedding from human to animal can be studied similarly
A laboratory technician with blond hair, wearing a white lab coat, safety glasses, face mask, and blue gloves, is working with equipment in a clean, modern lab environment. He is conducting genetic toxicology tests using a machine built into a white cabinet.

Technology Platforms

  • qPCR, RT-PCR, ddPCR
  • Meso Scale Discovery (MSD)
  • AlphaLISA
  • HPLC
  • LC-MS/MS
  • Polychromatic and Spectral Flow Cytometry
  • Western Blot