Small-Scale Commercial Production

Background

A global, large-scale pharmaceutical manufacturer had produced for many years a legacy drug product that cured a highly contagious and difficult-to-treat disease. Over the years, the demand for the drug product waned and manufacturing the drug product in one of its facilities was no longer cost-effective. The company was searching for a small-scale, fully CGMP pharmaceutical contract manufacturing organization (CMO) that could manufacture the small-volume drug product more economically. PGC was chosen to be that contract pharmaceutical manufacturer.

Challenge

The global pharmaceutical company had to be able to transfer the process technology and analytical technology in a timely manner, and its partner had to establish the supply chain and coordinate all the parties involved, including a new international active pharmaceutical ingredient (API) supplier, regulatory consultants, analytical testing provider and repackager.

The API was known to be both moisture- and temperature-sensitive. Additionally, the physical properties of the API included poor flow ability and required special capsule manufacturing capabilities. PGC worked in partnership with this major pharmaceutical manufacturer throughout the technology transfer of both the GMP manufacturing and the analytical methods. Additionally, PGC worked with regulators to gain FDA approval to manufacture and market the drug in not only the United States but also worldwide.

To complete the technology transfer, PGC established a supply chain by negotiating and coordinating multiple relationships, including an international bulk API supplier, regulatory consultants, specialty analytical testing providers, repackager and cold-chain management.

Owing to the small volume of drug product produced annually, expiration of the API kept in inventory was of great concern in terms of minimizing waste. Moreover, owing to the limited use of the drug, expiration dating of the final product was also of concern.

Results

PGC now operates the only FDA-approved site in the world to manufacture this lifesaving drug. Furthermore, PGC is now responsible for all aspects of commercialization for this drug, including final product release testing, distribution and marketing. PGC is proud to maintain the commercial supply of this vital drug that is a cure to a highly contagious, difficult-to-treat condition that the World Health Organization (WHO) suggests will impact nearly half a million people each year, with cases found in nearly every country surveyed by the organization.

To address concerns of API and final product expirations, PGC was able to design a process that increased batch sizes by 50% and develop an approach by changing the packaging to extend shelf life of the final product by 50% through accelerated stability studies, intermediate stability studies, and long-term stability studies. Now, PGC is working on stability studies to double the original shelf life of the final product.