Buyer Name: Centre for Process Innovation Limited
Buyer Address: Wilton Centre, Redcar, UK, TS10 4RF, United Kingdom
Contact Name: E-Tendering
Contact Email: e-tendering@uk-cpi.com
Contact Telephone: +44 1642455340
Framework for QC Analytical Testing Requirements
Buyer Contact Info
Status
complete
complete
Procedure
open
open
Value
1000000.0 GBP
1000000.0 GBP
Published
22 May 2025, 08:01
22 May 2025, 08:01
Deadline
n/a
n/a
Contract Start
n/a
n/a
Contract End
n/a
n/a
Category
services
services
CPV
71620000 - Analysis services
71620000 - Analysis services
Region
n/a
n/a
Awarded To
Assured Micro Ltd, Wickham Micro Ltd, Reading Scientific Serices Ltd, ITS Testing Services (UK) Ltd trading as Intertek P&IA, SGS UK Ltd, Assured Micro, CatSci Ltd
Assured Micro Ltd, Wickham Micro Ltd, Reading Scientific Serices Ltd, ITS Testing Services (UK) Ltd trading as Intertek P&IA, SGS UK Ltd, Assured Micro, CatSci Ltd
Official Source
Open Find a Tender
Open Find a Tender
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).
Linked Documents
No linked documents found for this notice.
Opportunity Context
Lots
Lot Title: RNA Therapeutic/Vaccines
Lot Description: 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
Lot 2 Status: cancelled
Lot 2 Has Options: No
Lot 2 Award Criterion (quality): GMP Questionnaire
Lot 2 Award Criterion (quality): Technical Specification
Lot 2 Award Criterion (quality): Turnaround timescales (Lead Time)
Lot 2 Award Criterion (quality): - Qualification and Experience
Lot 2 Award Criterion (quality): Order Processing, Account Management & Customer Service
Lot Title: Recombinant Protein Therapeutics
Lot Description: 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
Lot 3 Status: cancelled
Lot 3 Has Options: No
Lot 3 Award Criterion (quality): GMP Questionnaire
Lot 3 Award Criterion (quality): Technical Specification
Lot 3 Award Criterion (quality): Turnaround timescales (Lead Time)
Lot 3 Award Criterion (quality): Qualification and Experience
Lot 3 Award Criterion (quality): Order Processing, Account Management & Customer Service
Lot Title: Process and Product Microbiology (Teesside Area)
Lot Description: 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)
Lot 4 Status: cancelled
Lot 4 Has Options: No
Lot 4 Award Criterion (quality): GMP Questionnaire
Lot 4 Award Criterion (quality): Technical Specification
Lot 4 Award Criterion (quality): Turnaround timescales (Lead Time)
Lot 4 Award Criterion (quality): Qualification and Experience
Lot 4 Award Criterion (quality): Order Processing, Account Management & Customer Service
Lot Title: Process and Product Microbiology (Glasgow Area)
Lot Description: 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)
Lot 5 Status: cancelled
Lot 5 Has Options: No
Lot 5 Award Criterion (quality): GMP Questionnaire
Lot 5 Award Criterion (quality): Technical Specification
Lot 5 Award Criterion (quality): Turnaround timescales (Lead Time)
Lot 5 Award Criterion (quality): Qualification and Experience
Lot 5 Award Criterion (quality): Order Processing, Account Management & Customer Service
Lot Title: Oligonucleotides
Lot Description: 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)
Lot 6 Status: cancelled
Lot 6 Has Options: No
Lot 6 Award Criterion (quality): GMP Questionnaire
Lot 6 Award Criterion (quality): Technical Specification
Lot 6 Award Criterion (quality): Turnaround timescales (Lead Time)
Lot 6 Award Criterion (quality): Qualification and Experience
Lot 6 Award Criterion (quality): Order Processing, Account Management & Customer Service
Lot Title: Water Testing (Glasgow Area)
Lot Description: 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.)
Lot 1 Status: cancelled
Lot 1 Has Options: No
Lot 1 Award Criterion (quality): GMP Questionnaire
Lot 1 Award Criterion (quality): Technical Specification
Lot 1 Award Criterion (quality): Turnaround timescales (Lead Time)
Lot 1 Award Criterion (quality): Qualification and Experience
Lot 1 Award Criterion (quality): Order Processing, Account Management & Customer Service
Contracts
Contract Title: Water Testing (Glasgow Area)
Contract Title: RNA Therapeutic/Vaccines
Contract Title: Recombinant Protein Therapeutics
Contract Title: Process and Product Microbiology (Teesside Area)
Contract Title: Process and Product Microbiology (Glasgow Area)
Contract Title: Oligonucleotides
Awards
Award Title: Water Testing (Glasgow Area)
Award Title: RNA Therapeutic/Vaccines
Award Title: Recombinant Protein Therapeutics
Award Title: Process and Product Microbiology (Teesside Area)
Award Title: Process and Product Microbiology (Glasgow Area)
Award Title: Oligonucleotides
Raw Notice JSON
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"description": "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.\nThe requirements for Recombinant Protein analysis include:\n-\tMethod development, verification and Phase appropriate validation (as required)\n-\tIntegrity analysis for Recombinant Protein drug substance and drug product (release and stability analysis)\n-\tProcess impurity testing for Recombinant Protein drug substance and drug product",
"hasOptions": false,
"id": "3",
"status": "cancelled",
"title": "Recombinant Protein Therapeutics"
},
{
"awardCriteria": {
"criteria": [
{
"description": "5",
"name": "GMP Questionnaire",
"type": "quality"
},
{
"description": "20",
"name": "Technical Specification",
"type": "quality"
},
{
"description": "20",
"name": "Turnaround timescales (Lead Time)",
"type": "quality"
},
{
"description": "20",
"name": "Qualification and Experience",
"type": "quality"
},
{
"description": "5",
"name": "Order Processing, Account Management \u0026 Customer Service",
"type": "quality"
},
{
"description": "30",
"type": "price"
}
]
},
"description": "Our facility in Darlington will require Microbiology testing to support the RNA-LNP and Recombinant Protein GMP manufacture.\nThe following analysis is required, all under Ph.Eur:\n-\tEndotoxin (Buffers)\n-\tEndotoxin (Process product Protein)\n-\tEndotoxin (Process product RNA and RNA-LNP)\n-\tBioburden (Buffers)\n-\tBioburden (Process product Protein)\n-\tBioburden (Process product RNA and RNA-LNP)",
"hasOptions": false,
"id": "4",
"status": "cancelled",
"title": "Process and Product Microbiology (Teesside Area)"
},
{
"awardCriteria": {
"criteria": [
{
"description": "5",
"name": "GMP Questionnaire",
"type": "quality"
},
{
"description": "20",
"name": "Technical Specification",
"type": "quality"
},
{
"description": "20",
"name": "Turnaround timescales (Lead Time)",
"type": "quality"
},
{
"description": "20",
"name": "Qualification and Experience",
"type": "quality"
},
{
"description": "5",
"name": "Order Processing, Account Management \u0026 Customer Service",
"type": "quality"
},
{
"description": "30",
"type": "price"
}
]
},
"description": "Our facility in Glasgow will require Microbiology testing to support the GMP manufacturing of oligonucleotide therapies.\nThe following analysis is required, all under Ph.Eur:\n-\tEndotoxin (Process product oligonucleotide)\n-\tBioburden (Process product oligonucleotide)",
"hasOptions": false,
"id": "5",
"status": "cancelled",
"title": "Process and Product Microbiology (Glasgow Area)"
},
{
"awardCriteria": {
"criteria": [
{
"description": "5",
"name": "GMP Questionnaire",
"type": "quality"
},
{
"description": "20",
"name": "Technical Specification",
"type": "quality"
},
{
"description": "20",
"name": "Turnaround timescales (Lead Time)",
"type": "quality"
},
{
"description": "20",
"name": "Qualification and Experience",
"type": "quality"
},
{
"description": "5",
"name": "Order Processing, Account Management \u0026 Customer Service",
"type": "quality"
},
{
"description": "30",
"type": "price"
}
]
},
"description": "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.\nThe requirements for oligonucleotides analysis include:\n-\tChemical analysis for oligonucleotide drug substance and drug product (release and stability analysis)\n-\tMethod development, verification and phase appropriate validation (as required)",
"hasOptions": false,
"id": "6",
"status": "cancelled",
"title": "Oligonucleotides"
},
{
"awardCriteria": {
"criteria": [
{
"description": "5",
"name": "GMP Questionnaire",
"type": "quality"
},
{
"description": "20",
"name": "Technical Specification",
"type": "quality"
},
{
"description": "20",
"name": "Turnaround timescales (Lead Time)",
"type": "quality"
},
{
"description": "20",
"name": "Qualification and Experience",
"type": "quality"
},
{
"description": "5",
"name": "Order Processing, Account Management \u0026 Customer Service",
"type": "quality"
},
{
"description": "30",
"type": "price"
}
]
},
"description": "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:\n-Microbiological monitoring (Ph. Eur.)\n-Bacterial endotoxin testing (Ph. Eur.)",
"hasOptions": false,
"id": "1",
"status": "cancelled",
"title": "Water Testing (Glasgow Area)"
}
],
"mainProcurementCategory": "services",
"procurementMethod": "open",
"procurementMethodDetails": "Open procedure",
"status": "complete",
"title": "Framework for QC Analytical Testing Requirements"
}
}