Notice Information
Notice Title
Framework for QC Analytical Testing Requirements
Notice 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).
Lot Information
Water Testing (Glasgow Area)
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.)
Renewal: 48 months with 1 additional 12 months period extension options at the discretion of the Authority.
RNA Therapeutic/VaccinesOur 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
Renewal: 48 months with 1 additional 12 months period extension options at the discretion of the Authority.
Recombinant Protein TherapeuticsOur 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
Renewal: 48 months with 1 additional 12 months period extension options at the discretion of the Authority.
Process and Product Microbiology (Teesside Area)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)
Renewal: 48 months with 1 additional 12 months period extension options at the discretion of the Authority.
Process and Product Microbiology (Glasgow Area)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)
Renewal: 48 months with 1 additional 12 months period extension options at the discretion of the Authority.
OligonucleotidesThe 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)
Renewal: 48 months with 1 additional 12 months period extension options at the discretion of the Authority.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-r6ebe6-0000774949
- Publication Source
- Public Contracts Scotland
- Latest Notice
- https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=MAY530845
- Current Stage
- Award
- All Stages
- Tender, Award
Procurement Classification
- Notice Type
- OJEU - F3 - Contract Award Notice
- Procurement Type
- Framework
- Procurement Category
- Services
- Procurement Method
- Open
- Procurement Method Details
- Open procedure
- Tender Suitability
- Not specified
- Awardee Scale
- SME
Common Procurement Vocabulary (CPV)
- CPV Divisions
71 - Architectural, construction, engineering and inspection services
-
- CPV Codes
71620000 - Analysis services
Notice Value(s)
- Tender Value
- Not specified
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- £1,000,000 £1M-£10M
Notice Dates
- Publication Date
- 22 May 20259 months ago
- Submission Deadline
- 12 Sep 2024Expired
- Future Notice Date
- Not specified
- Award Date
- 4 Mar 202511 months ago
- Contract Period
- Not specified - Not specified
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Complete
- Awards Status
- Not Specified
- Contracts Status
- Active
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- CENTRE FOR PROCESS INNOVATION LIMITED
- Contact Name
- E-Tendering
- Contact Email
- e-tendering@uk-cpi.com
- Contact Phone
- +44 1642455340
Buyer Location
- Locality
- REDCAR
- Postcode
- TS10 4RF
- Post Town
- Cleveland
- Country
- England
-
- Major Region (ITL 1)
- TLC North East (England)
- Basic Region (ITL 2)
- TLC3 Tees Valley
- Small Region (ITL 3)
- TLC32 South Teesside
- Delivery Location
- TLM83 Inverclyde, East Renfrewshire, and Renfrewshire
-
- Local Authority
- Redcar and Cleveland
- Electoral Ward
- Dormanstown
- Westminster Constituency
- Redcar
Further Information
Notice Documents
-
https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=AUG511905
Framework for QC Analytical Testing Requirements - 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). -
https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=MAY530845
Framework for QC Analytical Testing Requirements - 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).
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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