An integral part of AmplifyBio’s vision is to continuously assess the needs of our clients and invest in valuable, differentiating, and translational capabilities to serve the needs of advanced therapy development. An example of that commitment comes from the growth of cell and gene therapy and other biologic modalities, causing a notable shift in the types of pathology assessments that best determine the safety and efficacy of a drug.
While the goals of pathology studies for any modality can include assessing off-target effects, demonstrating functionality, and ensuring long-term safety, the nature of cell, gene, and mRNA therapies requires a more nuanced look. This entails examining not only protein expression resulting from gene and mRNA modalities but also evidence of tissue integration by cell therapies and the distribution of nucleic acid through FISH/ISH techniques.
To meet the growing needs of the advanced therapy market, AmplifyBio invested in a significant expansion of the capacity for these tools, including:
- Expansion of the lab space to add two Leica Bond Rx platforms for state-of-the-art advanced staining and investment in training experienced, dedicated staff to ensure high quality, consistency, and high throughput that withstands the rigor of a GLP environment.
- Whole-slide digital scanning and image analysis available
Optimized Assays Include
- IHC (Immunohistochemistry)/IF (Immunofluorescence)
- Confirmation of ultimate protein expression, including appropriate tissue and cellular distribution
- TUNEL (Terminal deoxynucleotidyl transferase dUTP Nick End Labeling):
- Assessing intended or unintended apoptosis/necrosis
- ISH (In Situ Hybridization)/FISH (Fluorescence In Situ Hybridization):
- Confirmation of nucleic acid sequence uptake/amplification in target cells
- Determining gene expression levels, copy changes, gene insertion and chromosomal rearrangements
- miRNA (microRNA) Assays:
- Measuring intended and off-target miRNA expression induced by a gene therapy
- bDNA (branched DNA) Assays:
- Gain insights into the efficacy or off-target effects of gene therapies by measuring expression levels of targeted genes or transcripts
The rise in advanced therapy drugs is expanding safety checks beyond traditional toxicity markers. There’s a growing need for high-quality, efficient methods to analyze tissue, like histology, IHC, ISH, and immunofluorescence. AmplifyBio is committed to improving its services to meet the needs of advanced therapy development and lead in cell and gene therapy.
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