PharmaLogic Technology Transfer and Process Development Services
…Your reliable collaboration partner from development to production
The PharmaLogic team has decades of experience working with numerous PET tracers, from antibodies to peptides and small molecules, and qualification of these manufacturing processes. From Phase 1 through Commercial Launch, PharmaLogic has the experience and track record to help sponsors and innovators make their products successful.
Product automation and optimization performed under Current Good Manufacturing Practices (cGMP) results in reproducibility and commercialization. PharmaLogic assists pharma partners in the tech transfer process resulting in consistency and efficiency in PET drug manufacturing across a network of facilities. cGMP ensures new PET biomarkers have the FDA required consistency, quality and purity.
PharmaLogic collaborates with pharma and academic partners to improve PET tracer development processes, product yields, decrease synthesis time, and simplify purification steps – key activities for successful regulatory filing and commercial product launch. We can modify and tailor the partnership based on the specific needs of each potential partner.
PharmaLogic Partnership Offerings
- Production Process and Quality Control Troubleshooting
- Product and Process Validation
- Technology Transfer (site setup) including process development and optimization for radiotracer production, initial qualification for new radiotracers for regulatory filing
- Product Stability Programs
- Radiochemistry production facility design including radiochemistry synthesis unit, cyclotron and QC equipment procurement, installation, qualification, and documentation
Contact us to discuss your current project/product
- Identification of Primary Investigators and imaging facilities through a wide network for research programs and clinical studies.
- Establish and improve PET tracer production process and transfer to an automated synthesis platform.