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).

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) 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.)