PET Production News and Updates

PET Production Facility Update (as of October 27, 2025)  Our new MGH PET Production Facility has been recently inspected by the FDA. Overall, the inspection confirmed the soundness of our operations and our readiness to address the observations promptly and effectively. We are optimistic about addressing all the observations with vigor and formulating a strong response to the FDA within the timeframe. Our response to the FDA inspection has been finalized and was sent out as of last week. 

PET Production Facility Update (as of September 2, 2025) We were waiting on clarifications from the FDA regarding our restart. We have received communication back and the agency affirmed that human use production can occur after a successful facility inspection followed by the revalidation of all IND products.  The inspection date is yet to be determined.  Inspections are not normally announced until the week prior FDA’s planned inspection date.  At this time, restart of production is expected to occur in Spring 2026. In the meantime, we continue our efforts as we have been working actively in the new PET Production Lab in Edwards 013 to ensure all products will be ready for validation so that our tracers will be available as soon as possible.

PET Production Facility Update (as of August 14, 2025)  Work in the new PET Production Lab (Edwards 013) is progressing. During the enabling phase, our team has successfully completed two radiopharmaceutical syntheses over the past two weeks, with additional products scheduled for testing later this month.
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PET Radiopharmaceutical Availability (as of June 26, 2025)

Our on-site PET Production Facility is currently unable to provide human-use PET drugs for IND studies. Below is an overview of what this means for your research projects:

Currently Unavailable Tracers

  • C-11 PiB, F-18 SDM8, F-18 3F4AP
    The Core team has actively investigated potential alternatives but were unable to procure these tracers through external sources at this time. 

Internally Produced Tracers with External Availability

F-18 T807 (TAUVID)

  • Source: PETNET Boston

  • IRB Requirement: PETNET must be listed as a production site.

  • Injection Window: Monday–Friday, 2:00–5:15 pm

  • Costs:

    • Imaging-only Core fee: $2,550

    • External tracer fee: $3,850 + shipping ($60–$100) 

*General pricing at time of posting, unless otherwise negotiated in sponsor contracts. Tracer prices may vary based on the individual Radiopharmacy.*

For budget impact, please contact Slav Lerner, PET Core Business Manager, vlerner@mgh.harvard.edu.

F-18 MK6240

  • Source: PETNET New York (limited to ~2–3 doses/week)

  • Requirements: Lab must be registered with Lantheus and have IRB approval for external sourcing.

  • Injection Window: Tuesday–Thursday, 2:30–3:30 pm

  • Costs:

    • Imaging-only Core fee: $2,550

    • External tracer fee: $2,750 + shipping ~$735 (increased from $450 this summer) 

*General pricing at time of posting, unless otherwise negotiated in sponsor contracts. Tracer prices may vary based on the individual Radiopharmacy.*

For budget impact, please contact Slav Lerner, PET Core Business Manager, vlerner@mgh.harvard.edu.

List of Tracers Currently Available via External Sourcing

  • Tracers we can get externally if properly provided for on the IRB:
    • F-18 PBR06
    • F-18 Amyvid
    • F-18 NeuraCeq
    • F-18 NAV4694 (Also need approval from Lantheus)
    • F-18 Tauvid
    • F-18 MK6240 (Also need approval from Lantheus)
    • F-18 FDG
    • F-18 NaF
    • F-18 FDOPA (very limited quantities)
Of Note: Ga-68 tracers are still being produced at this time​ on-site and will not be impacted by downtime.
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ALL PET CORE IMAGING SCANNERS ARE UP AND RUNNING 
  • GE Discovery MI 5 Ring PET/CT
  • GE Signa PET/MR
If you have a study coming online and do not see your tracer listed above, please contact the PET Core team directly to discuss availability and sourcing options. Please do not hesitate to reach out anytime with questions or concerns—we’re here to support you and your research.
Email: MGHPETCore@massgeneralbrigham.org  
Revised on 2025-10-27 21:50:58 UTC