Basic & Preclinical Research

Always nimble,
always quick.

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Need to deliver early-phase study results on-time and under budget, but just don’t have the bandwidth or resources? Just choose Quantigen for fast and affordable research-focused or preclinical study design support. Quantigen scientists work closely with clients to customize, optimize, and to implement each workflow. We can even provide the SOPs and quality control processes needed for successful deployment and quality monitoring in your own laboratory.

 

Basic biology research

Here’s just a sampling of our current supported applications. (But by all means, help us add to our ever-growing list!):

Next-generation Sequencing (NGS)
  • T-cell receptor (TCR) sequencing
  • Somatic mutation analysis
  • RNA-Seq and miRNA-Seq
Digital PCR
  • Rare mutation detection
  • Meticulously quantified molecular standards
Capillary/Sanger Sequencing
  • Sequence confirmation
  • Fragment analysis
Quantitative PCR (Real-Time PCR/qPCR)
  • Germ line and somatic genotyping
  • Copy-number variation (DNA)
  • Expression analysis of mRNA, miRNA, lncRNA
  • Infectious disease assay development
Sample Preparation (DNA, RNA and protein)
  • FFPE, FNA, LCM
  • Whole blood, plasma, serum, PBMCs
  • Stool, urine, nasal/pharyngeal, and buccal samples
Immunoassays
  • ELISA
  • Immunogenicity
Pilot-Scale Lyophilization
Flow Cytometry
  • Immunophenotyping
  • Cell-cycle analysis
  • Gene expression
Bioinformatics
  • Intra-sample NGS gene expression distribution
  • Inter-sample differential gene expression (study group analysis)
  • TCR repertoire analysis
Cell Biology—Immunophenotyping IHC & FISH (with partners)
  • (Immunohistochemistry and fluorescence in-situ hybridization)
  • Test menu & development
 

Biomarker development and initial validation

Whether based on DNA, RNA, or protein, Quantigen has your biomarker discovery and validation needs covered. Quantigen scientists have the experience and deep technical knowledge to provide robust, customized biomarker development services. Steps we’d be happy to do for you:

  • Optimizing sample preparation and establishing robust assay standard operating protocols.

  • Designing data analysis, reporting, and transfer workflows.

  • Setting analytical-, process-, and clinical-validation benchmarks for near-term and future compliance needs (including ISO 13485 traceability standards).

  • Conducting iterative rounds of assay testing and refinement to meet or exceed validation benchmarks.

High-throughput sample processing and analysis

Does your laboratory have hundreds, thousands, or even tens of thousands of samples to process and/or analyze? Quantigen Biosciences has the instrumentation and scalability, as well as the highly skilled staff, to handle most workloads. Our laboratory was custom-built to accommodate good laboratory practices (GLP) and is equipped with instrumentation validated to multiple regulatory standards. You can count on accurate and timely results that are generated using standardized SOPs and communicated via secure data-transfer mechanisms.

Bioproduction quality control

Establishing quality-control systems and reagents is a crucial step in the development of biological assays and agents for use in research and medicine. The Quantigen scientific team has expert knowledge and experience in these systems, with professional backgrounds in both the pharmaceutical and biotechnology industries. In addition, our laboratories are built for compliance, and have the accreditations and certifications [LM1] you’re looking for in a CRO.

  • Residual DNA testing

  • Synthetic assay standards

  • Known-positive biological standards

  • Standards for in-process checkpoints