Large and Nimble. How We Adjusted for One Client's Changing Conditions.

Although we are a sizeable service company, Ricerca can still "turn on a dime" to accommodate changing drug development needs... even in the middle of a project.

An example: A biotech company hired us to develop a manufacturing process for an anticancer drug requiring multi-step chiral synthesis and the use of pyrophoric raw materials in the process. Ricerca had already developed a superior route when the project scope unexpectedly changed, creating an immediate demand for the delivery of additional quantities of API for clinical trials.

Rather than continuing the traditional stepwise process development, an immediate scale-up was begun with process improvements being implemented in the lab in a series parallel approach. The process was successfully scaled to 100 gallons and 7.5 runs were completed to deliver 90 kg of high purity API, ready to be formulated.

The payoff for our client? We provided sufficient clinical material to stay on schedule and a successful scaled-up process.