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).
Buyer
Centre for Process Innovation Limited
Value
Not provided
Published
12 Aug 2024
Closes
12 Sept 2024
Procurement details
Source
Pcs
Region
United Kingdom
Procurement method
Open
Category
Services
Contract starts
Not provided
Contract ends
Not provided
CPV classifications
71620000
Analysis services
Lots
Lot 1 Water Testing (Glasgow Area)
Value not provided
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.)
Delivery: UKM83
Lot 2 RNA Therapeutic/Vaccines
Value not provided
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...
Delivery: UKM83
Lot 3 Recombinant Protein Therapeutics
Value not provided
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 appropri...
Delivery: UKM83
Lot 4 Process and Product Microbiology (Teesside Area)
Value not provided
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 (Pr...
Delivery: UKM83
Lot 5 Process and Product Microbiology (Glasgow Area)
Value not provided
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)
Delivery: UKM83
Lot 6 Oligonucleotides
Value not provided
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 d...
Delivery: UKM83
Documents
Unlock document linkFramework for QC Analytical Testing Requirements
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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 requi...
Contract notice · Web page
Framework for QC Analytical Testing Requirements
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Award notice · Web page
Contains public sector information licensed under the Open Government Licence v3.0.