Shedding Assays Development
Our company specializes in developing shedding assays tailored to characterize the release of viral vectors from animal models or treated humans. These assays serve as vital tools for risk assessment in gene and cell therapies.
Transcription and Translation Characterization
Our company provides a range of molecular and protein-based platforms to accurately characterize the transcription and translation processes of transgenes. By leveraging these platforms, we generate robust data essential for assessing the safety and efficacy of gene-modified therapies across preclinical and clinical stages.
Species-specific Studies
Our company conducts shedding studies across diverse species, including rodents (transgenic, immune-deficient, healthy) and large animals such as rabbits, mini-pigs, canines, and non-human primates (NHP) under specific immunosuppression regimes. Mimicking clinical routes of administration ensures relevance and accuracy in our assessments.
Secretion/Excretion Profiling
Our services extend to determining the secretion/excretion profiles of viral vectors in various bodily fluids such as serum, saliva, feces, urine, semen, nasal secretions, and tears. This detailed profiling aids in understanding the dissemination patterns of vectors post-administration.
Post-dose Monitoring and Safety Mitigation
Our company supports post-dose monitoring of vector shedding using robust assays. This monitoring is crucial for mitigating safety concerns related to replication-competent viral vectors and ensuring environmental safety.
Data Translation for Clinical Design
Our expertise allows us to translate data from non-clinical shedding studies to estimate the likelihood and extent of shedding in humans accurately. This information plays a pivotal role in informing and optimizing clinical study designs for gene and cell therapies.
Cross-Species Shedding Studies
In addition to studying shedding within species, our company also conducts cross-species shedding studies. These studies help elucidate viral shedding patterns from humans to animals and vice versa, providing comprehensive insights into interspecies transmission dynamics.
