--- title: "Framework for QC Analytical Testing Requirements" ocid: "ocds-r6ebe6-0000774949" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-r6ebe6-0000774949" markdown_url: "https://d3tenders.com/contract/ocds-r6ebe6-0000774949.md" json_url: "https://d3tenders.com/contract/ocds-r6ebe6-0000774949.json" source: "Public Contracts Scotland" current_stage: "Award" buyer: "CENTRE FOR PROCESS INNOVATION LIMITED" published: "2025-05-22" --- # Framework for QC Analytical Testing Requirements Buyer: CENTRE FOR PROCESS INNOVATION LIMITED Current stage: Award OCID: ocds-r6ebe6-0000774949 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-r6ebe6-0000774949) [Download OCDS JSON](https://d3tenders.com/contract/ocds-r6ebe6-0000774949.json) ## Summary In the public procurement process led by the Centre for Process Innovation Limited, a contract titled "Framework for QC Analytical Testing Requirements" was executed, addressing the need for analytical services on drug substances and products for early-phase clinical trials. Situated in the UK, the Centre for Process Innovation Ltd has operated as the buyer and central purchasing body, with the completion of the award stage confirmed as of 2025-05-22. The procurement, conducted through an open procedure, covers six lots with services spanning locations like Teesside, Glasgow, and Darlington. This process commenced with a tender phase on 2024-08-12, with the submission close on 2024-09-12. This tender presents an excellent opportunity for small and medium-sized enterprises (SMEs) specialising in analytical services, particularly those experienced in handling biotechnological and pharmaceutical materials. Opportunities abound for firms working in quality control, scientific analysis, and method development. The involvement of diverse suppliers such as Assured Micro Ltd, Wickham Micro Ltd, and Reading Scientific Services Ltd indicates a competitive environment focused on innovation and quality. Businesses with expertise in microbiological testing, process development, and validation in the pharmaceutical sector would find this contract well-suited to expand their market presence and drive business growth. ## Notice 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/Vaccines 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 Renewal: 48 months with 1 additional 12 months period extension options at the discretion of the Authority. Recombinant Protein Therapeutics 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 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. Oligonucleotides 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) Renewal: 48 months with 1 additional 12 months period extension options at the discretion of the Authority. ## Key Details | Field | Value | | --- | --- | | Publication source | Public Contracts Scotland | | Latest notice | https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=MAY530845 | | 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 | | All stages | Tender, Award | ## Dates | Field | Value | | --- | --- | | Publication date | 22 May 2025 | | Submission deadline | 12 Sep 2024 | | Future notice date | Not specified | | Award date | 4 Mar 2025 | | Contract period | Not specified | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | Not specified | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | £1,000,000 | ## Status | Field | Value | | --- | --- | | Tender status | Complete | | Lots status | Complete | | Awards status | Not specified | | Contracts status | Active | ## Buyer | Field | Value | | --- | --- | | Main buyer | CENTRE FOR PROCESS INNOVATION LIMITED | | Locality | REDCAR | | Post town | Cleveland | | Postcode | TS10 4RF | | Country | England | | ITL 1 | TLC North East (England) | | ITL 2 | TLC3 Tees Valley | | ITL 3 | TLC32 South Teesside | | Local authority | Redcar and Cleveland | | Electoral ward | Dormanstown | | Westminster constituency | Redcar | | Delivery location | TLM83 Inverclyde, East Renfrewshire, and Renfrewshire | ## Supplier | Field | Value | | --- | --- | | Number of suppliers | 6 | | Supplier names | ASSURED MICRO; CATSCI; ITS TESTING SERVICES (UK) LTD TRADING AS INTERTEK P&IA; READING SCIENTIFIC SERICES; SGS; WICKHAM MICRO | ## CPV Codes ### Divisions - 71 - Architectural, construction, engineering and inspection services ### Codes - 71620000 - Analysis services ## Release History - 22 May 2025 at 00:00 - Award - OJEU - F3 - Contract Award Notice - https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=MAY530845 - 12 Aug 2024 at 00:00 - Tender - OJEU - F2 - Contract Notice - https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=AUG511905 ## 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). ## Notice URLs - http:// - http://www.uk-cpi.com - https://api.publiccontractsscotland.gov.uk/v1/Notice?id=ocds-r6ebe6-0000774949 - https://in-tendhost.co.uk/uk-cpi/aspx/Home ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-r6ebe6-0000774949. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-r6ebe6-0000774949.json.