Dr. Sarah Stevens, former VP of Drug Development Sciences at Quotient Sciences, discusses the recent acquisition of Arcinova and the integration of drug substance, drug product, and clinical testing capabilities in a Drug Development & Delivery Special Feature Report, "Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs"
For the past decade, Quotient Sciences has created a delivery platform that integrates drug product and clinical testing activities to achieve program acceleration. To support this further, Quotient Sciences recently acquired Arcinova, the UK-based CDMO, because of its expertise and capability in early-stage drug substance and bioanalysis work.
"We see a great opportunity for investing in and integrating drug substance services into our existing drug product and clinical testing platform," says Sarah Stevens, Vice President of Drug Development Sciences, Quotient Sciences.
Drug substance manufacturing often sits on the critical path in early development with drug product manufacturing and clinical trial initiation routinely suffering from late API supply, she says. As one of the major causes of project delays, it is important for biotech companies to work closely with API manufacturers early in the development process to ensure the drug substance is not only supplied on time but that potential formulation or downstream challenges have also been identified or flagged up front.
"The investment in this capability will enable the integration of drug substance, drug product, and clinical testing capabilities – all under one organization with a single Project Management function," she says.