Precision Molecular Biology Services to Advance Cell and Gene Therapy Development
As cell and gene therapies continue to redefine the future of medicine, reliable molecular biology services are essential for supporting innovative programs from discovery to clinic. At Smithers Pharmaceutical Development Services, we bring together scientific expertise, versatile platforms, and regulatory rigor to ensure your molecular assays deliver meaningful data that stands up to scrutiny.
Fit-for-Purpose Assay Development and Validation
Our molecular biology team combines decades of experience with a methodical approach to assay development and validation. Whether your project requires supporting preclinical safety studies, advancing a clinical trial, or preparing a regulatory submission, Smithers designs solutions tailored to your program’s unique goals.
From method transfer and bridging to full validation, our scientists are skilled at adapting assays for regulated environments without compromising sensitivity or accuracy. With a dedicated PCR suite equipped with multiple redundant platforms, every study is performed within a framework of quality and compliance.
Cutting-Edge Platforms for Reliable Data
Smithers leverages an extensive toolkit of molecular biology technologies to address even the most complex challenges in bioanalysis:
- Droplet Digital PCR (ddPCR): Ideal for absolute quantification of nucleic acids, rare variant detection, and interference mitigation. Our Biorad QX200 system ensures exceptional sensitivity and reproducibility.
- Quantitative PCR (qPCR): A gold-standard approach for amplifying and quantifying DNA sequences in real time, performed on the Applied Biosystems QS7 platform.
- Automated Nucleic Acid Extraction: Using ThermoFisher KingFisher Flex and Promega Maxwell RCS 48 systems, we achieve consistent recovery and high-throughput isolation of genomic DNA, plasmid DNA, and RNA.
Applications that Drive Tomorrow’s Therapies
Smithers’ molecular biology services support a wide spectrum of applications critical to advancing modern therapeutics, including:- Biodistribution studies for cell and gene therapy vectors
- Transgene expression analysis
- Vector integration monitoring
- Rare event detection in oncology and infectious disease
Why Partner with Smithers?
When you choose Smithers, you’re choosing a partner defined by:- Scientific Depth: Experts with decades of molecular biology experience spanning vaccines, biologics, and advanced therapies.
- Platform Versatility: A diverse suite of technologies designed to meet the nuances of each project.
- Custom-Tailored Methods: Consultative, client-specific approaches to method development and optimization.
- Regulatory Excellence: Operations under GCLP, GLP, and CLIA standards to ensure your data meets global regulatory expectations.
Smithers molecular biology services integrate seamlessly into your development pipeline—bringing clarity, consistency, and confidence to every stage.
