Framework for QC Analytical Testing Requirements

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.)

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

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

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)

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)

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)