Translational Pharmaceutics integrates real-time drug product manufacturing and clinical testing, using processes designed to reduce the timelines and cost of early stage drug development. Quotient has applied this platform in early development programs at its own manufacturing and clinical facilities in Nottingham, UK.
Quotient’s real-time manufacturing approach offers a number of advantages in this setting, including:flexibility of drug product manufacturing in response to patient recruitment rates, with product typically being supplied in less than three weeks,customization of drug product dose and/or composition according to patient/study need, and in response to clinical data emerging from the on-going program;and increased efficiency of drug substance consumption.
Mark Egerton, chief executive officer of Quotient Clinical, said, “Approximately 30% of the industry’s drug development pipeline is focused on cancer. We have developed our real-time manufacturing and supply capabilities to support this specialist area with first-in-patient and proof-of-concept programs. We have already supported multiple development programs in the UK and mainland Europe, and will shortly be embarking on a similar project in North America. In these, and other future programs, we will be helping our clients to accelerate their early development pipelines and increase overall R&D productivity.”