Tender

Appointment of a Contract Manufacturing Organisation for Production of DST-F to GMP Standards

  • ANIMAL AND PLANT HEALTH AGENCY

UK4: Tender notice - Procurement Act 2023 - view information about notice types

Notice identifier: 2025/S 000-073510

Procurement identifier (OCID): ocds-h6vhtk-052ac4 (view related notices)

Published 10 November 2025, 3:17pm

Last edited 13 November 2025, 12:39pm

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Changes to notice

This notice has been edited. The previous version is still available.

Estimated extension end date updated.

Scope

Reference

C30459

Description

A Contract Manufacturing Organisation (CMO) certified to EU Good Manufacturing Practice (GMP) standards is required to work in partnership with the Authority to achieve UK Marketing Authorisation (MA) and, thereafter, undertake the scaled up production and supply of the DST-F reagent, a diagnostic skin test to Detect Infected among Vaccinated Animals (DIVA). This will involve the technology transfer of the research grade fusion protein-based reagent from the current ISO-accredited provider.

Total value (estimated)

  • £9,786,429 excluding VAT
  • £11,999,998.80 including VAT

Above the relevant threshold

Contract dates (estimated)

  • 20 April 2026 to 19 April 2033
  • Possible extension to 19 April 2035
  • 9 years

Description of possible extension:

The Contracting Authority reserves the right to extend the Contract by up to twenty-four (24) months, in increments of twelve (12) months, subject to satisfactory performance and continued operational need.

Any extension shall be exercised by giving the Supplier no less than six (6) months' written notice prior to the expiry of the initial term.

All terms and conditions shall remain unchanged during the extension period unless otherwise agreed in writing.

Options

The right to additional purchases while the contract is valid.

The Contracting Authority may, at its sole discretion, exercise one or more of the following options during the term of the Contract:

- Grant a commercial licensing agreement to the successful Supplier for the manufacture and

supply of DST-F to Rest of World (RoW) markets,

subject to separate agreement and regulatory approvals.

- Expand the scope of services to include support for additional Marketing Authorisation applications outside Great Britain.

- Increase the volume of DST-F doses required, subject to policy changes and budget availability.

These options are provided for in the original procurement and shall be exercised only where they do not substantially alter the nature of the Contract.

The Supplier shall be notified in writing of the Authority's intention to exercise any option, and the parties shall agree any contract variations

Main procurement category

Goods

CPV classifications

  • 33600000 - Pharmaceutical products

Contract locations

  • UK - United Kingdom

Justification for not using lots

Dividing the contract into separate lots has been considered not feasible due to the highly integrated nature of the required services, which include technology transfer, manufacturing, production of consistency batches, quality assurance and control, and regulatory support during the Marketing Authorisation submission process. Fragmentation would introduce significant coordination challenges, increase the risk of quality inconsistency, and complicate the management of interdependent activities. A single-source award is commercially more attractive, offering streamlined delivery, operational efficiency, and clear accountability across all stages of product development and supply.


Participation

Legal and financial capacity conditions of participation

As set out in the Bidder Pack.

Technical ability conditions of participation

As set out in the Bidder Pack.

Particular suitability

Small and medium-sized enterprises (SME)


Submission

Enquiry deadline

15 December 2025, 12:00pm

Submission type

Tenders

Tender submission deadline

15 December 2025, 12:00pm

Submission address and any special instructions

The procurement documents are available for unrestricted and full direct access, free of charge, at https://defra-family.force.com/s/Welcome

Any questions, requests to participate or tender submissions must be submitted electronically via this portal.

If you need technical help with the Atamis system, either when registering, or when completing a tender, please contact the Atamis support team e-mail Support@Atamis.co.uk or phone Tel: 029 2279 0052.

Tenders may be submitted electronically

Yes

Languages that may be used for submission

English

Award decision date (estimated)

1 April 2026


Award criteria

This table contains award criteria for this lot
Name Description Type Weighting
Technical

As set out in the Bidder Pack.

Quality 70.00%
Commercial

As set out in the Bidder Pack.

Price 30.00%

Other information

Description of risks to contract performance

Regulatory Risks

1) Marketing Authorisation Refusal for the Cattle BCG Vaccine;

The Contracting Authority has submitted a Marketing Authorisation (MA) application to the Veterinary Medicines Directorate for the Cattle BCG Vaccine, which is complementary to the DST-F reagent.

Likelihood: Medium

This may result in the deployment of DST-F being significantly delayed or no longer required.

2) Marketing Authorisation Refusal for DST-F reagent;

Risk that the Marketing Authorisation is refused

Likelihood: Medium

This could impact contract viability and deployment timelines .

Policy and Political Risks

1) Change in TB policy during contract term

Likelihood: Low

This may affect DST-F demand and contract scope

2) Impact of Government Spending Review (2026/27 onwards)

Likelihood: Medium

This could affect affordability and budget availability

3) Farm Trial Specificity Below Expectations

1) Farm trials may indicate that product specificity is lower than expected. This would not constitute trial failure, but significantly low specificity would require the Authority to undertake a model reassessment and root cause analysis.

Likelihood: Low

This could affect the contract deployment timelines.

Applicable trade agreements

  • Government Procurement Agreement (GPA)
  • Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)

Conflicts assessment prepared/revised

Yes


Procedure

Procedure type

Competitive flexible procedure

Competitive flexible procedure description

This procurement is being conducted as a Competitive Flexible Procedure in accordance with the Procurement Act 2023. Completion and submission of all documents will be conducted via the Authority's eSourcing system.

As outlined in 'Part 2 - Procurement Specific Requirements of the Bidder Pack', the Authority reserves the right to conduct negotiations with all participating Tenderers following the completion of Stage 1 - Initial Tender Evaluation. However, Tenderers are strongly advised not to rely on the optional negotiation phase to clarify or introduce critical elements of their submission.

Important Notice to Tenderers

Initial tender submissions must be clear, complete, and comprehensive, including all relevant information, assumptions, and pricing. The Authority may choose not to proceed to the negotiation stage, and therefore, Tenderers should submit their best possible offer in the first instance.

Stage 1 - Initial Tender Stage

1. Procurement Specific Questionnaire-

Tenderers must complete a set of questions to enable the Authority to verify core supplier information, exclusions, and debarment status. Responses will be assessed to ensure compliance with all mandatory and discretionary requirements.

2. Conditions of Participation -

Responses will be evaluated to confirm that Tenderers meet the minimum capability thresholds. Tenderers failing to meet the minimum capability requirement will be excluded from the procurement process.

3. Tender Evaluation -

All compliant tenders will be evaluated in accordance with the scoring methodology detailed in this document and within the Authority's eSourcing platform.

Stage 2 - Negotiation Stage (Optional)

If the Authority elects to proceed with negotiations:

• Tenderers will receive Initial Assessment Summaries, providing high-level feedback on their submissions.

• The Authority will issue negotiation details and agenda.

• Negotiations will be strictly limited to the topics specified in the Bidder Pack.

Stage 3 - Final Tender Stage

1. Invitation to Submit Final Tenders -

Following the conclusion of negotiations, Tenderers will be invited to submit their Final Tenders.

2. Clarification Period -

A five (5) working day window from date of Invitation to Submit Final Tender will be provided for written clarification questions via Atamis.

3. Final Submission Window -

Tenderers will have fourteen (14) working days to resubmit their final tender via Atamis.

4. Final Evaluation -

Final tenders will be evaluated using the same Award Criteria.

Technical and commercial scores will be combined to determine the Most Advantageous Tender.

Tie-Breaker Procedure -

In the event of a tie in total scores following evaluation of the Final Tenders, the Authority will apply a tie-breaker to award the contract. This process will only apply to the Tenderers who have the highest overall scoring tenders and will be applied in this listed order;

1) The Tenderer who gained the higher score for E01 'GMP Compliance' will be awarded the contract.

2) If the tie still endures after step 1 the Tenderer who gained the higher commercial score will be awarded the contract.


Contracting authority

ANIMAL AND PLANT HEALTH AGENCY

  • Public Procurement Organisation Number: PBHC-6261-BLLQ

Seacole Building, 2 Marsham Street

London

SW1P 4DF

United Kingdom

Contact name: Olubunmi Akinmade

Email: olubunmi.akinmade@defra.gov.uk

Website: https://defra-family.force.com/s/Welcome

Region: UKI32 - Westminster

Organisation type: Public authority - central government