At Smithers, our Molecular Biology capabilities are designed to support the evolving landscape of cell and gene therapies.
Our scientific team has extensive years of scientific expertise and a rigorous, methodical approach to the most complex challenges in bioanalysis. We offer fit-for-purpose solutions in Molecular Assays, from development to validation, meeting regulatory expectations.
Our work spans across preclinical and clinical development. Our state-of-the-art dedicated PCR suite, is equipped with the latest technology across multiple and redundant molecular biology platforms.
All within a framework of scientific integrity and regulatory compliance.
For absolute quantification of nucleic acids and rare variant detection, droplet digital PCR offers enhanced precision, sensitivity and mitigates interference effects. Our platforms include the Biorad QX200 system.
Also known as real-time PCR, is a widely used laboratory technique used to amplify and quantify a specific DNA sequence in real time. Our platforms include Applied Biosystems QS7.
Automated methods ensure consistency of recovery and high throughput nucleic acid extraction, whether it is genomic DNA, plasmid DNA or Total RNA isolation. Our platforms include the ThermoFisher KingFisher Flex and the Promega Maxwell RCS 48.
Our molecular biologists bring decades of experience with cell and gene therapies, vaccines, and complex biologics
We deploy a diverse suite of technologies—from qPCR to ultra-sensitive ddPCR—to address even the most nuanced questions.
Our method development is consultative and client-specific, designed to ensure your assays are optimized for both performance and regulatory review.
Smithers operates under GCLP, GLP, and CLIA standards, ensuring your data stands up to regulatory scrutiny around the globe.
At Smithers, our molecular biology services bring together cutting-edge platforms, seasoned scientists, and unwavering quality to support the development of tomorrow’s therapies.
Can you support method transfer from another CRO or internal lab?
Yes. Our method development team specializes in method transfer, bridging, and optimization, with a strong track record of adapting assays for regulated studies.
Are your molecular assays validated for regulatory submissions?
Absolutely. We follow a rigorous validation process aligned with current regulatory guidance, and we support both exploratory and GxP-regulated studies.
Do you offer support for multiplexed cytokine analysis in conjunction with molecular assays?
Yes. Our capabilities include single and multiplex immunoassays (e.g., MSD, Quanterix, Gyrolab) and ELISPOT for cytokine profiling in combination with gene expression readouts.