ARCINOVA
Abstract: Arcinova is a Contract Research and Development Organisation (CRDO), providing the life sciences industry with a comprehensive range of services. At Arcinova, we are focused on Process Research, Development, Scale-Up and small scale manufacturing, including bioanalysis, DMPK, regulatory and consulting services, covering drug candidates in Development and launched to the Market. Recently, a request was submitted to Arcinova which required the manufacture of API in a vial to be used in Phase I single ascending dose (SAD) multiple ascending dose (MAD) Phase I trials. The timeline for completion was extremely tight and required manufacture and shipping of the drug product to be executed in 2 days, decreasing the standard duration by more than 2 weeks.
Description: A customer of Arcinova, in the form of a Japanese Big-Pharma Corporation, requested the manufacture of API in a vial to be used in Phase I single ascending dose (SAD) multiple ascending dose (MAD) Phase I trials. The main issue identified with the customer was in regard to the timelines. A rapid 4 day process was required from dose determination to patient administration. As a result of the clinic’s location and the time required to ship the product, Arcinova would have a maximum of 48 hours from dose determination to shipping the product to the clinic.
In order to achieve an accelerated manufacturing programme, standard manufacturing procedures were replaced with project specific procedures (see figure below). The project required Arcinova to be agile in its approach, thus creating an efficient and streamlined project. The project specific procedures were managed through Change Controls which were reviewed and approved by Quality Assurance.
A trial was conducted in order to test the new procedure, including a mock shipment exercise. This allowed Arcinova to demonstrate that the timelines were attainable. The trial also provided an opportunity for the clinic to become familiar with Arcinova documentation.
Through the efficient management of change control and creation of project specific procedures, Arcinova managed to reduce the manufacturing and shipment duration from 2-3 weeks to 48 hours.
Category: Drug Product
Type: Small Molecules
Contact: Nathalie Huther ([email protected])