In order to progress to clinical trials, the client needed to characterise the materials used in their therapy and prepare a dossier submission. The client did not have the expertise or facilities to do this in-house, so reached out to RSSL. With around 20 components, including raw, contact and pathway materials, an extensive array of instrumentation was required. In addition, whilst some of these materials had existing pharmacopeia monographs, others were more complex and novel with little regulatory guidance available and required RSSL’s support to develop appropriate methods. In particular, the key materials responsible for the therapeutic efficacy posed a challenge to work with and develop methods for.