Follow your nucleic acid therapeutic with IMGM's qPCR Biodistribution Services

Request a quote

Contracting and Audit

By selecting IMGM as outsourcing partner for your GLP-certified pre-clinical study, you can count on a professional business relationship. We negotiate Confidentiality Disclosure Agreements (CDAs), Non-Disclosure Agreements (NDAs), Frame Service Agreements (FSAs), Material Transfer Agreements (MTAs) and Quality Agreements with you as necessary. In addition, we are regularly audited by customers from the pharmaceutical and biotechnological industry and invite you to get to know us in more detail as well. For more information on our Quality Management, click here.

Your benefits are:

  • Professional business relationship ensured by contracts
  • Reliable quality management system
  • Possibility to audit IMGM

Project Design

Consulting and experimental design in close communication between you and your project manager at IMGM include topics like:

  1. Nucleic acid therapeutic characterization
    • Type of analyzed DNA or RNA molecule (miRNA, mRNA, ssDNA, circular DNA etc.)
    • Optimal target region for qPCR primer positioning

  2. Study volume and sample preparation
    • Number of study animals, samples and sources (organs, body fluids, the injection site etc.)
    • Optimal preparation of each sample type
    • Appropriate reference materials

  3. Study overview and timeline
    • From first sample to final results
    • Realistic time frames for documentation, quality management and communication
    • Validation and main study requirements

Your benefits are: 

  • Free of charge and in-depth consulting
  • Detailed project design by IMGM's biodistribution experts
  • Consideration of regulatory authorities' requirements

Validation Study

The method of detection is established and validated for your specific target and sample sources. Calibration curves ensure accurate absolute quantification of your target nucleic acid by qPCR.

Important aspects to consider are:

  1. Establishment of nucleic acid extraction
    • Optimization of nucleic acid purification for each tissue type
    • Risk of contamination minimized by stringent working conditions
    • Quantity and quality control of every nucleic acid extract

  2. PCR assay design and validation
    • Design of a specific TaqMan or SYBR Green assay for the nucleic acid therapeutic
    • Wet-lab validation of optimal PCR conditions
    • Generation of calibration curve with defined target concentrations in appropriate background matrices
    • Quantification of validation study samples in triplicates

  3. Definition of quality control acceptance criteria
    • Clear-cut threshold values for qPCR accuracy and precision, sensitivity and selectivity
    • Definition of limit of detection and quantification (LOD, LOQ)
    • Precise determination of nucleic acid therapeutic recovery rate and stability
    • Consideration of all regulatory specifications

 Your benefits are:

  • High quality, project-optimized nucleic acid extraction
  • GLP-compliant, detailed validation of qPCR assays
  • Clearly defined quality control acceptance criteria and analytical range

Main Study

The nucleic acid therapeutic is quantified in the main study samples applying the validated qPCR assay and QC criteria from the validation study. Extensive GLP-compliant documentation in submission-ready format facilitates convenient communication with regulatory authorities.

Your benefits are:

  • Maximum qPCR accuracy by validation and internal controls
  • Highly precise absolute quantification of therapeutic as amount (fg) and copy numbers per mg organ

Documentation

Study plans and reports are of central importance for every biodistribution study. IMGM’s extensive GLP-compliant documentation clearly outlines project design, methods, experimental steps and results and facilitates convenient communication with regulatory authorities.

Your benefits are:

  • GLP-compliant documentation in submission-ready format
  • Comprehensive reporting and detailed graphics
  • High quality study plans and reports ensured by extensive quality assurance