Biodistribution and Shedding

The Pharmaron US team has over a decade of experience successfully supporting cell and gene therapy programs from preclinical through post approval. We understand the complex bioanalytical methods that need to be developed for cell and gene therapy programs and have the specialized expertise to develop qualify and validate robust assays in compliance with FDA/EMA requirements to support your therapeutic programs.

View as PDF: [Whitepaper] Biodistribution and Viral Shedding for Cell and Gene Therapy

View as PDF: Biodistriubution and Shedding

Services

Biodistribution
The aim of biodistribution studies is to determine levels of transgene and its product e.g. proteins, where possible

Biodistribution assays indicate if the target tissue is transduced successfully by the vector, and if so, how much is present in the tissue
Biodistribution data required to support first-in-human (FIH) trial
Samples for biodistribution: blood, plasma, CSF, tissues

Shedding
The aim of shedding studies is to determine the secretion/excretion profile of the virus/vector

Vector shedding represents a significant safety and environmental concern for replication-competent viral vectors
Data collected from non-clinical shedding studies is used to estimate the likelihood and extent of shedding in humans and to guide the design of clinical shedding studies
Samples for shedding: serum, saliva, feces, urine, semen, nasal

Choose an Experienced Partner
Utilize our experience to navigate through challenges, such as off-target amplification, variable sample volumes, potential cross-contamination, optimizing low-yield tissue

Capabilities

Technology Platforms: qPCR, RT-PCR, ddPCR, ELISA, HPLC, LC-MS/MS, Flow Cytometry, Western Blot, Luminex
Preclinical Species: rodent, non-rodent
Quality: R&D, GLP, GCLP

Learn more about Pharmaron’s expertise by registering for our monthly CGT webinar series, which is focused on identifying key cell and gene therapy questions that arise during drug discovery and development. Register here.

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