D3 Tenders | GMP compliant Radiopharmaceutical Production Unit

Notice Information

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Notice Title

GMP compliant Radiopharmaceutical Production Unit

Notice Description

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. <br/><br/>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

Notice Details

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Publication & Lifecycle

Open Contracting ID: ocds-h6vhtk-03c69e
Publication Source: Find A Tender Service
Latest Notice: https://www.find-tender.service.gov.uk/Notice/012915-2023
Current Stage: Planning
All Stages: Planning

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

85 - Health and social work services

CPV Codes

85111200 - Medical hospital services

85121200 - Medical specialist services

Notice Value(s)

Tender Value: £40,000,000 £10M-£100M
Lots Value: Not specified
Awards Value: Not specified
Contracts Value: Not specified

Notice Dates

Publication Date: 5 May 20233 years ago
Submission Deadline: Not specified
Future Notice Date: 31 May 2023Expired
Award Date: Not specified
Contract Period: Not specified - Not specified
Recurrence: Not specified

Notice Status

Tender Status: Planned
Lots Status: Planned
Awards Status: Not Specified
Contracts Status: Not Specified

Buyer & Supplier

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Contracting Authority (Buyer)

Main Buyer: GUY'S AND ST THOMAS' NHS FOUNDATION TRUST
Contact Name: Available with D3 Tenders Premium →
Contact Email: Available with D3 Tenders Premium →
Contact Phone: Available with D3 Tenders Premium →

Buyer Location

Locality: LONDON
Postcode: SE1 9RT
Post Town: South East London
Country: England
Major Region (ITL 1): TLI London
Basic Region (ITL 2): TLI4 Inner London - East
Small Region (ITL 3): TLI44 Lewisham and Southwark
Delivery Location: TLI44 Lewisham and Southwark
Local Authority: Southwark
Electoral Ward: London Bridge & West Bermondsey
Westminster Constituency: Bermondsey and Old Southwark

Further Information

Notice URLs

Open Contracting Data Standard (OCDS)

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