What We Do

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Who should be interested in Optimal Tracers Services?

  • Clinical and preclinical researchers

  • Contract research organizations

  • Pharmaceutical and Biotech companies

  • Radiopharmaceutical providers and developers

  • Hospitals

  • Universities

  • Physicians

Differentiating Features of Optimal Tracers

  • Provides seamless integration from radiochemistry to imaging with its experienced molecular imaging parent company

  • Private laboratory

  • Flexible and focused

  • High activity runs up to 10Ci/batch.  Can process 3-5 runs per day with full QC

  • Process optimization from mCi to multi Ci level with full QC, documentation, regulatory filling, stability studies, and robustness runs

  • Clinical research and tracer development

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Case Study 1

Large Pharmaceutical Company
5 year relationship

 

Activities Supported:

  • Provide F-18 PET radiotracer for Phase 2 clinical trials (95% batch success rate)
  • Process and technology transfer for validated manufacturing and QC methods
  • Provide monthly report for manufacturing and quality control issues, deviations and failures
  • Accommodate any last minute (less than 24 hours) requests for clinical dose

Distribution:  Western US and Canada

Case Study 2

Large Pharmaceutical Company
4 year relationship

 

Activities Supported:

  • Provide development, process investigative and improvement services to new and already approved PET tracers
  • High activity stability studies (commercial scale up to 15Ci)
  • Vial Studies at various temperature and radioactivity ranges
  • New formulation studies
  • Inter and intra-operator variability
  • Troubleshoot manufacturing and QC issues
  • Cleaning validation
  • Data review and reanalysis for routine and non-routine results
  • Tech transfer report

Case Study 3

Large Western US Health System

 

Activities Supported:

Two separate physician sponsored IND's

  • Licensed proprietary tracers for use in clinical trials
  • Filed DMF and reference letters for IND filing
  • Support CMC section for IND filings
  • Transferred methods from different modules and validated the production and QC methods
  • Supply of PET tracers for clinical research

Distribution:  Sacramento and Los Angeles

Case Study 4

Midwestern US University

 

Activities supported:

  • GMP lab setup
  • Develop and implement site specific Quality System
  • Staff Training
  • IQ, OQ, and PQ equipment
  • Qualification for clinical production
  • Support IND filing and help FDA enquiries

Case Study 5

Small biotech startup

 

Activities supported:

  • Provide preclinical generic doses like F-MISO as a proof of concept for new drug in development studies

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Customized Radiochemistry Facility Design 

In addition to our multi-site production capability, OT has expertise in customized radiochemistry (F-18 and C-11) facility design for preclinical and clinical research:

 

  • Process development and optimization for radiotracer production

  • Transition from preclinical work to clinical production and quality control

  • Technology transfer and initial qualification for new radiotracers for regulatory filing

  • Customized document preparation for manufacturing and quality control

  • Troubleshoot production and QC issues

  • Radiochemistry production and quality control facility design

  • Radiochemistry synthesis unit, cyclotron and QC equipment procurement, installation, qualification, documentation and maintenance

  • Training for GMP production, QC and regulatory aspects