Construction Contract Leads
No location provided
Category Services
Type
No. of Lots 6
Status Active
Published 12th Aug 2024
Reference | ocds-h6vhtk-0489eb |
Common Procurement Vocabulary | Analysis services |
Procurement Method | Open procedure |
Value | - |
No location provided
Category Services
Type
No. of Lots 6
Status Active
Published 12th Aug 2024
Reference | ocds-h6vhtk-0489eb |
Common Procurement Vocabulary | Analysis services |
Procurement Method | Open procedure |
Value | - |
Section I: Contracting authority
I.1) Name and addresses
Centre for Process Innovation Limited
Wilton Centre
Redcar
TS10 4RF
Contact
E-Tendering
e-tendering [at] uk-cpi.com
Telephone
+44 1642455340
Country
United Kingdom
NUTS code
UK - United Kingdom
Internet address(es)
Main address
Buyer's address
I.2) Information about 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
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
I.4) Type of the contracting authority
Body governed by public law
I.5) Main activity
Other activity
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 - Analysis services
II.1.3) Type of contract
Services
II.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).
II.1.6) Information about lots
This contract is divided into lots: Yes
Tenders may be submitted for maximum number of lots
6
II.2) Description
II.2.1) Title
Water Testing (Glasgow Area)
Lot No
1
II.2.2) Additional CPV code(s)
- 71620000 - Analysis services
II.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
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
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
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.2.10) 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
II.2) Description
II.2.1) Title
RNA Therapeutic/Vaccines
Lot No
2
II.2.2) Additional CPV code(s)
- 71620000 - Analysis services
II.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
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
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
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.2.10) 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
II.2) Description
II.2.1) Title
Recombinant Protein Therapeutics
Lot No
3
II.2.2) Additional CPV code(s)
- 71620000 - Analysis services
II.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
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
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
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.2.10) 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
II.2) Description
II.2.1) Title
Process and Product Microbiology (Teesside Area)
Lot No
4
II.2.2) Additional CPV code(s)
- 71620000 - Analysis services
II.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
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
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
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.2.10) 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
II.2) Description
II.2.1) Title
Process and Product Microbiology (Glasgow Area)
Lot No
5
II.2.2) Additional CPV code(s)
- 71620000 - Analysis services
II.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
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
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
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.2.10) 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
II.2) Description
II.2.1) Title
Oligonucleotides
Lot No
6
II.2.2) Additional CPV code(s)
- 71620000 - Analysis services
II.2.3) Place of performance
NUTS codes
- UKM83 - Inverclyde, East Renfrewshire and Renfrewshire
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
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
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.2.10) 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
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
Framework agreement with several operators
Envisaged maximum number of participants to the framework agreement: 3
IV.1.8) Information about the 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 September 2024
Local time
12:00pm
IV.2.4) Languages in which tenders or requests to participate may be submitted
English
IV.2.7) Conditions for opening of tenders
Date
12 September 2024
Local time
12:00pm
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 .
A sub-contract clause has been included in this contract. For more information see:
Community benefits are included in this requirement. For more information see:
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
Country
United Kingdom