Section one: Contracting authority
one.1) Name and addresses
Centre for Process Innovation Limited
Wilton Centre
Redcar
TS10 4RF
Contact
E-Tendering
Telephone
+44 1642455340
Country
United Kingdom
NUTS code
UK - United Kingdom
Internet address(es)
Main address
Buyer's address
https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA30305
one.2) Information about joint procurement
The contract is awarded by a central purchasing body
one.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 above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://in-tendhost.co.uk/uk-cpi/aspx/Home
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Other activity
Research And Development
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Framework for QC Analytical Testing Requirements
Reference number
3345
two.1.2) Main CPV code
- 71620000 - Analysis services
two.1.3) Type of contract
Services
two.1.4) Short description
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).
two.1.6) Information about lots
This contract is divided into lots: Yes
Tenders may be submitted for maximum number of lots
6
two.2) Description
two.2.1) Title
Water Testing (Glasgow Area)
Lot No
1
two.2.2) Additional CPV code(s)
- 71620000 - Analysis services
two.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
two.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.)
two.2.5) Award criteria
Quality criterion - Name: GMP Questionnaire / Weighting: 5
Quality criterion - Name: Technical Specification / Weighting: 20
Quality criterion - Name: Turnaround timescales (Lead Time) / Weighting: 20
Quality criterion - Name: Qualification and Experience / Weighting: 20
Quality criterion - Name: Order Processing, Account Management & Customer Service / Weighting: 5
Price - Weighting: 30
two.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.
two.2.10) Information about variants
Variants will be accepted: Yes
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
RNA Therapeutic/Vaccines
Lot No
2
two.2.2) Additional CPV code(s)
- 71620000 - Analysis services
two.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
two.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
two.2.5) Award criteria
Quality criterion - Name: GMP Questionnaire / Weighting: 5
Quality criterion - Name: Technical Specification / Weighting: 20
Quality criterion - Name: Turnaround timescales (Lead Time) / Weighting: 20
Quality criterion - Name: - Qualification and Experience / Weighting: 20
Quality criterion - Name: Order Processing, Account Management & Customer Service / Weighting: 5
Price - Weighting: 30
two.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.
two.2.10) Information about variants
Variants will be accepted: Yes
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
Recombinant Protein Therapeutics
Lot No
3
two.2.2) Additional CPV code(s)
- 71620000 - Analysis services
two.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
two.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
two.2.5) Award criteria
Quality criterion - Name: GMP Questionnaire / Weighting: 5
Quality criterion - Name: Technical Specification / Weighting: 20
Quality criterion - Name: Turnaround timescales (Lead Time) / Weighting: 20
Quality criterion - Name: Qualification and Experience / Weighting: 20
Quality criterion - Name: Order Processing, Account Management & Customer Service / Weighting: 5
Price - Weighting: 30
two.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.
two.2.10) Information about variants
Variants will be accepted: Yes
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
Process and Product Microbiology (Teesside Area)
Lot No
4
two.2.2) Additional CPV code(s)
- 71620000 - Analysis services
two.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
two.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)
two.2.5) Award criteria
Quality criterion - Name: GMP Questionnaire / Weighting: 5
Quality criterion - Name: Technical Specification / Weighting: 20
Quality criterion - Name: Turnaround timescales (Lead Time) / Weighting: 20
Quality criterion - Name: Qualification and Experience / Weighting: 20
Quality criterion - Name: Order Processing, Account Management & Customer Service / Weighting: 5
Price - Weighting: 30
two.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.
two.2.10) Information about variants
Variants will be accepted: Yes
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
Process and Product Microbiology (Glasgow Area)
Lot No
5
two.2.2) Additional CPV code(s)
- 71620000 - Analysis services
two.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
two.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)
two.2.5) Award criteria
Quality criterion - Name: GMP Questionnaire / Weighting: 5
Quality criterion - Name: Technical Specification / Weighting: 20
Quality criterion - Name: Turnaround timescales (Lead Time) / Weighting: 20
Quality criterion - Name: Qualification and Experience / Weighting: 20
Quality criterion - Name: Order Processing, Account Management & Customer Service / Weighting: 5
Price - Weighting: 30
two.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.
two.2.10) Information about variants
Variants will be accepted: Yes
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2) Description
two.2.1) Title
Oligonucleotides
Lot No
6
two.2.2) Additional CPV code(s)
- 71620000 - Analysis services
two.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
two.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)
two.2.5) Award criteria
Quality criterion - Name: GMP Questionnaire / Weighting: 5
Quality criterion - Name: Technical Specification / Weighting: 20
Quality criterion - Name: Turnaround timescales (Lead Time) / Weighting: 20
Quality criterion - Name: Qualification and Experience / Weighting: 20
Quality criterion - Name: Order Processing, Account Management & Customer Service / Weighting: 5
Price - Weighting: 30
two.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.
two.2.10) Information about variants
Variants will be accepted: Yes
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.2) Economic and financial standing
Selection criteria as stated in the procurement documents
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.3) Information about a framework agreement or a dynamic purchasing system
The procurement involves the establishment of a framework agreement
Framework agreement with several operators
Envisaged maximum number of participants to the framework agreement: 3
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
12 September 2024
Local time
12:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.7) Conditions for opening of tenders
Date
12 September 2024
Local time
12:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.2) Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
six.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)
six.4) Procedures for review
six.4.1) Review body
Glasgow Sheriff & Justice of the Peace Court
Sheriff Clerk's Office, 1 Carlton Place
Glasgow
G5 9DA
Country
United Kingdom