{ "tag": [ "compiled" ], "id": "ocds-h6vhtk-0489eb-2025-05-22T09:01:43+01:00", "date": "2025-05-22T09:01:43+01:00", "ocid": "ocds-h6vhtk-0489eb", "description": "(SC Ref:797494)", "initiationType": "tender", "tender": { "id": "3345", "legalBasis": { "id": "32014L0024", "scheme": "CELEX" }, "title": "Framework for QC Analytical Testing Requirements", "status": "complete", "classification": { "scheme": "CPV", "id": "71620000", "description": "Analysis services" }, "mainProcurementCategory": "services", "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. 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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", "awardCriteria": { "criteria": [ { "name": "GMP Questionnaire", "type": "quality", "description": "5" }, { "name": "Technical Specification", "type": "quality", "description": "20" }, { "name": "Turnaround timescales (Lead Time)", "type": "quality", "description": "20" }, { "name": "- Qualification and Experience", "type": "quality", "description": "20" }, { "name": "Order Processing, Account Management & Customer Service", "type": "quality", "description": "5" }, { "type": "price", "description": "30" } ] }, "contractPeriod": { "durationInDays": 1440 }, "hasRenewal": true, "renewal": { "description": "48 months with 1 additional 12 months period extension options at the discretion of the Authority." }, "submissionTerms": { "variantPolicy": "allowed" }, "hasOptions": false, "status": "cancelled" }, { "id": "3", "title": "Recombinant Protein Therapeutics", "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", "awardCriteria": { "criteria": [ { "name": "GMP Questionnaire", "type": "quality", "description": "5" }, { "name": "Technical Specification", "type": "quality", "description": "20" }, { "name": "Turnaround timescales (Lead Time)", "type": "quality", "description": "20" }, { "name": "Qualification and Experience", "type": "quality", "description": "20" }, { "name": "Order Processing, Account Management & Customer Service", "type": "quality", "description": "5" }, { "type": "price", "description": "30" } ] }, "contractPeriod": { "durationInDays": 1440 }, "hasRenewal": true, "renewal": { "description": "48 months with 1 additional 12 months period extension options at the discretion of the Authority." }, "submissionTerms": { "variantPolicy": "allowed" }, "hasOptions": false, "status": "cancelled" }, { "id": "4", "title": "Process and Product Microbiology (Teesside Area)", "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)", "awardCriteria": { "criteria": [ { "name": "GMP Questionnaire", "type": "quality", "description": "5" }, { "name": "Technical Specification", "type": "quality", "description": "20" }, { "name": "Turnaround timescales (Lead Time)", "type": "quality", "description": "20" }, { "name": "Qualification and Experience", "type": "quality", "description": "20" }, { "name": "Order Processing, Account Management & Customer Service", "type": "quality", "description": "5" }, { "type": "price", "description": "30" } ] }, "contractPeriod": { "durationInDays": 1440 }, "hasRenewal": true, "renewal": { "description": "48 months with 1 additional 12 months period extension options at the discretion of the Authority." }, "submissionTerms": { "variantPolicy": "allowed" }, "hasOptions": false, "status": "cancelled" }, { "id": "5", "title": "Process and Product Microbiology (Glasgow Area)", "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)", "awardCriteria": { "criteria": [ { "name": "GMP Questionnaire", "type": "quality", "description": "5" }, { "name": "Technical Specification", "type": "quality", "description": "20" }, { "name": "Turnaround timescales (Lead Time)", "type": "quality", "description": "20" }, { "name": "Qualification and Experience", "type": "quality", "description": "20" }, { "name": "Order Processing, Account Management & Customer Service", "type": "quality", "description": "5" }, { "type": "price", "description": "30" } ] }, "contractPeriod": { "durationInDays": 1440 }, "hasRenewal": true, "renewal": { "description": "48 months with 1 additional 12 months period extension options at the discretion of the Authority." }, "submissionTerms": { "variantPolicy": "allowed" }, "hasOptions": false, "status": "cancelled" }, { "id": "6", "title": "Oligonucleotides", "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. 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