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Summary

OCID:: ocds-h6vhtk-0489eb
Published by:: Centre for Process Innovation Limited
Authority ID:: AA20450
Publication date:: 13 August 2024
Deadline date:: 12 September 2024
Notice type:: Contract Notice
Has documents:: No
Has SPD:: No
Has Carbon Reduction Plan:: N/A

Abstract

You are invited to submit a tender for the following requirements; analytical services for multiple modalities drug substances and drug products required for early phase clinical trials. This tender is to cover the analytical services required for release analysis of drug substance (DS) and drug product (DP).

Full notice text

Contract notice

Section I: Contracting authority

I.1) Name and addresses

Centre for Process Innovation Limited

Wilton Centre

Redcar

TS10 4RF

Contact person: E-Tendering

Telephone: +44 1642455340

E-mail: e-tendering@uk-cpi.com

NUTS: UK

Internet address(es)

Main address: www.uk-cpi.com

Address of the buyer profile: https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA30305

I.2) Joint procurement

The contract is awarded by a central purchasing body

I.3) Communication

The procurement documents are available for unrestricted and full direct access, free of charge at:

https://in-tendhost.co.uk/uk-cpi/aspx/Home

Additional information can be obtained from the abovementioned address

Tenders or requests to participate must be sent electronically to:

https://in-tendhost.co.uk/uk-cpi/aspx/Home

I.4) Type of the contracting authority

Body governed by public law

I.5) Main activity

Other: Research And Development

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Framework for QC Analytical Testing Requirements

Reference number: 3345

II.1.2) Main CPV code

71620000

II.1.3) Type of contract

Services

II.1.4) Short description

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for maximum 6 lots

II.2) Description

Lot No: 1

II.2.1) Title

Water Testing (Glasgow Area)

II.2.2) Additional CPV code(s)

71620000

II.2.3) Place of performance

NUTS code:

UKM83

II.2.4) Description of the procurement

The MMIC facility near Glasgow will require microbiological testing of water samples in accordance with Ph. Eur. [0169]. The following analysis techniques are required and have been included in pricing schedule for comparison:

-Microbiological monitoring (Ph. Eur.)

-Bacterial endotoxin testing (Ph. Eur.)

II.2.5) Award criteria

Criteria below:

Quality criterion: GMP Questionnaire / Weighting: 5

Quality criterion: Technical Specification / Weighting: 20

Quality criterion: Turnaround timescales (Lead Time) / Weighting: 20

Quality criterion: Qualification and Experience / Weighting: 20

Quality criterion: Order Processing, Account Management & Customer Service / Weighting: 5

Price / Weighting: 30

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: Yes

Description of renewals:

48 months with 1 additional 12 months period extension options

at the discretion of the Authority.

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: Yes

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

Lot No: 2

II.2.1) Title

RNA Therapeutic/Vaccines

II.2.2) Additional CPV code(s)

71620000

II.2.3) Place of performance

NUTS code:

UKM83

II.2.4) Description of the procurement

Our facility in Darlington currently manufactures RNA-LNP vaccines and therapeutics for Phase 1 clinical trials. Both the drug substance and drug product are presented as liquid formulations.

The requirements for RNA-LNP analysis include:

- Method development, verification and Phase appropriate validation (as required)

- Integrity analysis for RNA In-process samples, RNA-LNP drug substance and drug product (release and stability analysis)

- Process impurity testing for RNA-LNP drug substance and drug product

II.2.5) Award criteria

Criteria below:

Quality criterion: GMP Questionnaire / Weighting: 5

Quality criterion: Technical Specification / Weighting: 20

Quality criterion: Turnaround timescales (Lead Time) / Weighting: 20

Quality criterion: - Qualification and Experience / Weighting: 20

Quality criterion: Order Processing, Account Management & Customer Service / Weighting: 5

Price / Weighting: 30

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: Yes

Description of renewals:

48 months with 1 additional 12 months period extension options

at the discretion of the Authority.

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: Yes

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

Lot No: 3

II.2.1) Title

Recombinant Protein Therapeutics

II.2.2) Additional CPV code(s)

71620000

II.2.3) Place of performance

NUTS code:

UKM83

II.2.4) Description of the procurement

Our facility in Darlington will, in the future, manufacture Recombinant protein vaccines and therapeutics produced in Microbial cell lines, for Phase 1 clinical trials. Both the drug substance and drug product are presented as liquid formulations.

The requirements for Recombinant Protein analysis include:

- Method development, verification and Phase appropriate validation (as required)

- Integrity analysis for Recombinant Protein drug substance and drug product (release and stability analysis)

- Process impurity testing for Recombinant Protein drug substance and drug product

II.2.5) Award criteria

Criteria below:

Quality criterion: GMP Questionnaire / Weighting: 5

Quality criterion: Technical Specification / Weighting: 20

Quality criterion: Turnaround timescales (Lead Time) / Weighting: 20

Quality criterion: Qualification and Experience / Weighting: 20

Quality criterion: Order Processing, Account Management & Customer Service / Weighting: 5

Price / Weighting: 30

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: Yes

Description of renewals:

48 months with 1 additional 12 months period extension options

at the discretion of the Authority.

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: Yes

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

Lot No: 4

II.2.1) Title

Process and Product Microbiology (Teesside Area)

II.2.2) Additional CPV code(s)

71620000

II.2.3) Place of performance

NUTS code:

UKM83

II.2.4) Description of the procurement

Our facility in Darlington will require Microbiology testing to support the RNA-LNP and Recombinant Protein GMP manufacture.

The following analysis is required, all under Ph.Eur:

- Endotoxin (Buffers)

- Endotoxin (Process product Protein)

- Endotoxin (Process product RNA and RNA-LNP)

- Bioburden (Buffers)

- Bioburden (Process product Protein)

- Bioburden (Process product RNA and RNA-LNP)

II.2.5) Award criteria

Criteria below:

Quality criterion: GMP Questionnaire / Weighting: 5

Quality criterion: Technical Specification / Weighting: 20

Quality criterion: Turnaround timescales (Lead Time) / Weighting: 20

Quality criterion: Qualification and Experience / Weighting: 20

Quality criterion: Order Processing, Account Management & Customer Service / Weighting: 5

Price / Weighting: 30

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: Yes

Description of renewals:

48 months with 1 additional 12 months period extension options

at the discretion of the Authority.

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: Yes

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

Lot No: 5

II.2.1) Title

Process and Product Microbiology (Glasgow Area)

II.2.2) Additional CPV code(s)

71620000

II.2.3) Place of performance

NUTS code:

UKM83

II.2.4) Description of the procurement

Our facility in Glasgow will require Microbiology testing to support the GMP manufacturing of oligonucleotide therapies.

The following analysis is required, all under Ph.Eur:

- Endotoxin (Process product oligonucleotide)

- Bioburden (Process product oligonucleotide)

II.2.5) Award criteria

Criteria below:

Quality criterion: GMP Questionnaire / Weighting: 5

Quality criterion: Technical Specification / Weighting: 20

Quality criterion: Turnaround timescales (Lead Time) / Weighting: 20

Quality criterion: Qualification and Experience / Weighting: 20

Quality criterion: Order Processing, Account Management & Customer Service / Weighting: 5

Price / Weighting: 30

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: Yes

Description of renewals:

48 months with 1 additional 12 months period extension options

at the discretion of the Authority.

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: Yes

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

Lot No: 6

II.2.1) Title

Oligonucleotides

II.2.2) Additional CPV code(s)

71620000

II.2.3) Place of performance

NUTS code:

UKM83

II.2.4) Description of the procurement

The facility at MMIC will manufacture both single and double stranded novel oligonucleotides for early phase clinical trials. The drug substance (API) may be a lyophilised powder or solution API and the finished drug product may be a solid or liquid formulation.

The requirements for oligonucleotides analysis include:

- Chemical analysis for oligonucleotide drug substance and drug product (release and stability analysis)

- Method development, verification and phase appropriate validation (as required)

II.2.5) Award criteria

Criteria below:

Quality criterion: GMP Questionnaire / Weighting: 5

Quality criterion: Technical Specification / Weighting: 20

Quality criterion: Turnaround timescales (Lead Time) / Weighting: 20

Quality criterion: Qualification and Experience / Weighting: 20

Quality criterion: Order Processing, Account Management & Customer Service / Weighting: 5

Price / Weighting: 30

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: Yes

Description of renewals:

48 months with 1 additional 12 months period extension options

at the discretion of the Authority.

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: Yes

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

Section III: Legal, economic, financial and technical information

III.1) Conditions for participation

III.1.2) Economic and financial standing

Selection criteria as stated in the procurement documents

III.2) Conditions related to the contract

Section IV: Procedure

IV.1) Description

IV.1.1) Type of procedure

Open procedure

IV.1.3) Information about a framework agreement or a dynamic purchasing system

The procurement involves the establishment of a framework agreement with several operators.

Envisaged maximum number of participants to the framework agreement: 3

IV.1.8) Information about Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: Yes

IV.2) Administrative information

IV.2.2) Time limit for receipt of tenders or requests to participate

Date: 12/09/2024

Local time: 12:00

IV.2.4) Languages in which tenders or requests to participate may be submitted

IV.2.7) Conditions for opening of tenders

Date: 12/09/2024

Local time: 12:00

Section VI: Complementary information

VI.1) Information about recurrence

This is a recurrent procurement: No

VI.2) Information about electronic workflows

Electronic ordering will be used

Electronic invoicing will be accepted

Electronic payment will be used

VI.3) Additional information

NOTE: To register your interest in this notice and obtain any additional information please visit the Public Contracts Scotland Web Site at https://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=774949.

A sub-contract clause has been included in this contract. For more information see: http://www.publiccontractsscotland.gov.uk/info/InfoCentre.aspx?ID=2363

Community benefits are included in this requirement. For more information see: https://www.gov.scot/policies/public-sector-procurement/community-benefits-in-procurement/

A summary of the expected community benefits has been provided as follows:

Through research and development

(SC Ref:774949)

VI.4) Procedures for review

VI.4.1) Review body

Glasgow Sheriff & Justice of the Peace Court

Sheriff Clerk's Office, 1 Carlton Place

Glasgow

G5 9DA

VI.5) Date of dispatch of this notice

12/08/2024

Coding

Commodity categories

ID	Title	Parent category
71620000	Analysis services	Technical testing, analysis and consultancy services

Delivery locations

ID	Description
100	UK - All

Alert region restrictions

The buyer has restricted the alert for this notice to suppliers based in the following regions.

ID	Description
There are no alert restrictions for this notice.

About the buyer

Main contact:: e-tendering@uk-cpi.com
Admin contact:: N/a
Technical contact:: N/a
Other contact:: N/a

Further information

Date	Details
No further information has been uploaded.

Framework for QC Analytical Testing Requirements

Contents

Summary

Abstract

Full notice text

Contract notice

Section I: Contracting authority

I.1) Name and addresses

I.2) Joint procurement

I.3) Communication

I.4) Type of the contracting authority

I.5) Main activity

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

II.1.2) Main CPV code

II.1.3) Type of contract

II.1.4) Short description

II.1.6) Information about lots

II.2) Description

II.2.1) Title

II.2.2) Additional CPV code(s)

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

II.2.11) Information about options

II.2.13) Information about European Union funds

II.2.1) Title

II.2.2) Additional CPV code(s)

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

II.2.11) Information about options

II.2.13) Information about European Union funds

II.2.1) Title

II.2.2) Additional CPV code(s)

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

II.2.11) Information about options

II.2.13) Information about European Union funds

II.2.1) Title

II.2.2) Additional CPV code(s)

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

II.2.11) Information about options

II.2.13) Information about European Union funds

II.2.1) Title

II.2.2) Additional CPV code(s)

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

II.2.11) Information about options

II.2.13) Information about European Union funds

II.2.1) Title

II.2.2) Additional CPV code(s)

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

II.2.11) Information about options

II.2.13) Information about European Union funds