---
title: "GMP compliant Radiopharmaceutical Production Unit"
ocid: "ocds-h6vhtk-03c69e"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-03c69e"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-03c69e.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-03c69e.json"
source: "Find A Tender Service"
current_stage: "Planning"
buyer: "GUY'S AND ST THOMAS' NHS FOUNDATION TRUST"
published: "2023-05-05"
---

# GMP compliant Radiopharmaceutical Production Unit

Buyer: GUY'S AND ST THOMAS' NHS FOUNDATION TRUST  
Current stage: Planning  
OCID: ocds-h6vhtk-03c69e

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## Summary

The Guy's and St Thomas' NHS Foundation Trust is planning a tender for the development of a GMP compliant Radiopharmaceutical Production Unit. The tender falls under the medical specialist services category and has a value of £40,000,000. The Radiopharmaceutical Production Unit aims to increase productivity, provide training opportunities, and ensure patient access to diagnostics and therapeutics over the next 15-20 years. The tender presents a commercial opportunity for industry partners to engage in the provision of Radiopharmacy services, capitalizing on the growing demand for radiopharmaceuticals.

This procurement process, currently at the planning stage, is initiated as a tender opportunity. The future notice date for communication is set for June 1, 2023. The location for the project is at St Thomas' Hospital in London, SE1 7EH. The industry category for this procurement is services. Interested businesses with expertise in medical services, radiopharmaceutical manufacturing, and healthcare technology are well-suited to compete in this tender and leverage the opportunities presented by the evolving landscape of radiopharmacy services.

## Notice

To develop a new, purpose-built, GMP compliant Radiopharmaceutical Production Unit for the aseptic manufacture of radiopharmaceuticals. The unit is to realise the productivity and commercial potential of the Radiopharmacy department and become an exemplar NHS Nuclear Medicine Unit providing training and education opportunities to the next generation of Radiopharmacists. 

The Unit will ensure equity of patient access to the increasing pipeline of RP diagnostics and therapeutics over the next 15-20 years and deliver the most innovative clinical research at its Investigational Medicinal Products (IMP) and Specials licensed facilities.

### Lot Information

Lot 1

The Authority, Guy's and St Thomas' NHS Foundation Trust (GSTT) is seeking expressions of interest from strategic and operational industry partners for the provision of Radiopharmacy (RP) services which ensure the realisation of the service's ambition: 

To develop a new, purpose-built, GMP compliant Radiopharmaceutical Production Unit for the aseptic manufacture of radiopharmaceuticals. The unit is to realise the productivity and commercial potential of the Radiopharmacy department and become an exemplar NHS Nuclear Medicine Unit providing training and education opportunities to the next generation of Radiopharmacists. 

The Unit will ensure equity of patient access to the increasing pipeline of RP diagnostics and therapeutics over the next 15-20 years and deliver the most innovative clinical research at its Investigational Medicinal Products (IMP) and Specials licensed facilities. 

Radiopharmacy sits in the Integrated and Specialist Medicine (ISM) directorate at GSTT, within CLIMP (Clinical Imaging and Medical Physics), and is part of the Nuclear Medicine Department based in the Borough Wing at Guy's Hospital. The unit manufactures tracers used in diagnostics scans, which are used to detect a wide range of conditions (including injuries; infections; tumours; heart disease; thyroid abnormalities; and kidney conditions) and also guide some cancer procedures.

Commerical Opportunity 
RP has seen significant growth in recent years. Manufacturing service lines have generated PS2.5m in billings (fy21/22) and is forecast to generate circa PS3m in revenues for fy22/23. We plan to double this within five years and treble revenues within 10 years.

RP is currently unable to realise its potential and increase capacity due to aeging facilities, lack of space and lack of resources. The unit frequently has to turn down opportunities to increase production. This equates to PSx00,000s of missed opportunity and unfulfilled orders, per annum. There is huge potential to increase production of radiopharmaceuticals as a number of market forces are currently driving up demand of RP's services, including:

* Increased use of theranostic combinations involving Gallium-68 e.g. prostate cancer and neuroendocrine tumours (NET) where radiopharmaceuticals are required for screening prior to therapy.
* Increased demand for routine Gallium-68 based radiopharmaceuticals including Ga-68-PSMA (prostate cancer) and Ga-68-DOTATATE (Neuroendocrine tumours (NETs) for diagnostic imaging, (both are commissioned by NHS England).
* Increased interest in research-based Gallium-68- tracers coming into clinical studies e.g. Ga-68-FAPI.
* Compromised supply while other units are shut (Guildford, Addenbrookes), due to tighter compliance and regulations, decreasing national capacity to supply radiotracers and increasing demand in compliant units.
* Lack of capacity in London for blood labelling driving up demand for those able to supply this service.
* Increased interest in cell tracking for Advanced Therapy Medicinal Products including CAR-T cell therapy.
* Lack of capacity elsewhere for producing radiopharmaceuticals for clinical trials.
* Increased interest in radiotracers for clinical trials (including novel radiopharmaceuticals emerging from the Imaging Sciences research laboratories at King's College London).
* Increased interest in radiopharmaceutical therapies in clinical trials, including Lu-177, Ac-225 and Pb-212

Current Client Base 
Our current client base is centred around Guy's and St Thomas' NHS Foundation Trust (Nuclear Medicine Department, Guy's Cancer Centre and the PET centre at St Thomas' Hospital). Radiopharmaceuticals are also provided daily to King's College NHS Foundation Trust; their Princess Royal Hospital site in Orpington; and a broad diverse range of private hospitals. 

Existing RP services include: 
Manufacture of Diagnostic Tc-99m based radiopharmaceuticals
Tc-99m is the most commonly used radioisotope for radiolabelling radiopharmaceuticals and is used for diagnosis of a wide range of medical conditions. The unit currently produces approximately c7000 vials per annum. 
Dispensing of diagnostic and therapeutic radiopharmaceuticals
The unit prepares non-Tc-99m diagnostic and therapeutic radiopharmaceuticals (including I-123, In-111, Se-75 and Ra-223 based radiopharmaceuticals), 
Manufacture of Ga-68 based radiopharmaceuticals
The unit manufactures routine and research Ga-68 radiopharmaceuticals, the most important of which are Ga-68 DOTATE (imaging of neuroendocrine tumours) and Ga-68 PSMA (imaging of prostate cancer).
Blood Cell Labelling 
White cells and denatured red cells are radiolabelled on site and then provided to a range of internal departments and external clients. The most common cell labelling conducted is for Red Cell Mass studies and ad hoc white cell-labelling.
Clinical Trials
RP holds a Manufacture of Investigational Medicinal Products licence (MIA(IMP)) and has manufactured novel radiopharmaceuticals for clinical trials, as well as producing radiopharmaceuticals for clinical studies. 
eGFR (kidney function) services
RP supports the eGFR service by processing and counting blood samples.

RP's current manufacturing portfolio can be found in appendix #1

RP current cost modelling 
RP costing model considers consumables, staff time, overheads and running costs for the unit in order to calculate cost per unit dose before applying a profit margin to facilitate future investment, maintenance and growth. Additional information: Please contact Adam Crowe for a fuller draft project brief and for a questionnaire to assist us.

Adam Crowe (B.A.Hons, ACIM, ABPI)
Commercial Service Directorate 
Guy's and St Thomas' NHS Foundation Trust
Email: adam.crowe@gstt.nhs.uk
Mob: 07769 300666
www.linkedin.com/in/adamcrowecimprofile

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/012915-2023 |
| Notice type | Planning Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Not Specified |
| Procurement method details | Not specified |
| Tender suitability | Not specified |
| Awardee scale | Not specified |
| All stages | Planning |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 5 May 2023 |
| Submission deadline | Not specified |
| Future notice date | 31 May 2023 |
| Award date | Not specified |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £40,000,000 |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Planned |
| Lots status | Planned |
| Awards status | Not specified |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | GUY'S AND ST THOMAS' NHS FOUNDATION TRUST |
| Locality | LONDON |
| Post town | South East London |
| Postcode | SE1 9RT |
| Country | England |
| ITL 1 | TLI London |
| ITL 2 | TLI4 Inner London - East |
| ITL 3 | TLI44 Lewisham and Southwark |
| Local authority | Southwark |
| Electoral ward | London Bridge & West Bermondsey |
| Westminster constituency | Bermondsey and Old Southwark |
| Delivery location | TLI44 Lewisham and Southwark |

## CPV Codes

### Divisions

- 85 - Health and social work services

### Codes

- 85111200 - Medical hospital services
- 85121200 - Medical specialist services

## Release History

- 5 May 2023 at 10:20 - Planning - Planning Notice - https://www.find-tender.service.gov.uk/Notice/012915-2023

## Notice URLs

- https://health-family.force.com/s/Welcome
- https://www.guysandstthomas.nhs.uk

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-03c69e. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-03c69e.json.