Puerto Rico: Regional difficulties related to fill/finish

A company’s fill/finish individual facilities can be negatively impacted by a region’s economic climate, as currently observed at some of the pharmaceutical manufacturing locations in Puerto Rico. Amgen has recently disclosed its operations may be affected by Puerto Rico’s debt load of approximately $70 billion (1). The United States territory has been in a recession for at least a decade. Amgen said in a February 2016 filing that although it has some finish operations in the Netherlands, a large portion of the company’s formulation, filling, and packaging of “certain Amgen principal products,” including Neupogen, Aranesp, Epogen, Prolia, Xgeva, “and substantially all of the formulation, fill and finish operations for Neulasta and Enbrel” remained at its manufacturing facility in Juncos, Puerto Rico (1). It also performs “all of the bulk manufacturing for Neulasta, Neupogen, and Aranesp, all of the purification of bulk Epogen material and substantially all of the bulk manufacturing for Prolia and Xgeva at this facility,” and says the global supply of its products and product candidates “is significantly dependent on the uninterrupted and efficient operation” of this facility in Puerto Rico and another in Thousand Oaks, California, in which the company makes clinical trial product candidates (1).

Amgen stated in its annual report that “If the Puerto Rico government is not able to restructure the debt obligations or get forbearance on debt payments, it could impact the territorial government’s provision of utilities or other services in Puerto Rico that we use in the operation of our business, create the potential for increased taxes or fees to operate in Puerto Rico, result in migration of workers from Puerto Rico to the mainland United States, and make it more expensive or difficult for us to operate in Puerto Rico” (1).

The 10-K document also details a shortage that occurred in their Puerto Rico facility of glass vials used to package Epogen, which it says delayed shipments, created supply constraints and stocking problems, and caused some contract disputes. “These events could negatively impact our ability to satisfy demand for our products, which could have a material adverse effect on our product use and sales and our business and results of operations.”

References

1. Amgen 10-K Annual Report 2016, accessed June 24, 2016.

Article Details

BioPharm International
Vol. 29, No. 9
Page: 21

Citation

When referring to this article, please cite as R. Hernandez, "Puerto Rico: Regional difficulties related to fill/finish," sidebar to "Parenteral Advisory: Outmoded Fill/Finish Technology," BioPharm International 29 (9) 2016.