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The CPDC provides high quality probe development and production services for universities, institutions, biotech, and pharmaceutical companies around the world.

We provide expertise through every phase of probe development: from the chemistry to preclinical and clinical testing to commercialization. This includes:

Discovery

Chemistry

  •       Custom synthesis of small molecules and peptides (precursors and reference standards)

  •       Radiolabelling: PET, SPECT, 3H, 125I, 14C, and Therapeutic Isotopes
  •       Separation & purification strategies

Biological Probe Validation

  •       In vitro and in vivo evaluation of molecular targets
  •       Probe validation in cell and animal models
  •       Small animal imaging: PET, SPECT and CT

Development

Chemistry and Manufacturing Controls

  •       GMP process development & validation
  •       Expertise in SPECT & PET agents
  •       Analytical and bioanalytical method development & validation
  •       Sterility and endotoxin testing
  •       Quality control & quality assurance audits
  •       Drug product formulation
  •       Stability testing

Regulatory Affairs

  •       Preparation and management of regulatory submissions
  •       Regulatory liaison

Consulting

  •       Probe development strategies
  •       Project management of probe development programs

Non-Clinical Safety

  •       Development of study designs
  •       Toxicology
  •       Pharmacokinetics
  •       Metabolism
  •       Biodistribution
  •       Dosimetry evaluation

Clinical Research

  •       Development of strategies and clinical trial designs
  •       Preparation of clinical protocols
  •       Case record form design
  •       Development of patient informed consent forms
  •       Clinical trial project management (single and multi-site)
  •       Data management
  •       Clinical trial reports
  •       Dosimetry evaluation

Production

  •       cGMP production of PET probes for oncology imaging

Commercialization

  •       Market research and analysis
  •       Identifying target customer profiles and demographics
  •       Developing business cases
  •       Assisting with an intellectual property (IP) strategy and application process(es)
  •       Negotiating licensing deals or the sale of IP
  •       Business plan and market strategy development
  •       Partnership development

For more information, please contact us »