Backlogged facility acquired and transformed into top three biotech manufacturing plant

Large scale filter housing in process development
Photo: An Amgen staff member working with a large purification tank.
 

How did Amgen’s commitment to quality and reliable supply become so integral to Amgen’s culture? Ensuring quality is, after all, one of Amgen’s core values. But it can be argued that one particular chapter in its history had a meaningful impact.

On July 16, 2002, Amgen acquired a company that was experiencing significant supply issues that directly impacted patients. In the months leading up to Amgen’s acquisition of lmmunex Corporation, the company announced a massive waiting list in the tens of thousands for its biologic medicine.

Rhode Island manufacturing facility.Rhode Island manufacturing facility.

Amgen’s history of manufacturing biologic medicines allowed for the swift renovation of the company’s Rhode Island facility. Following the acquisition, the facility has come to be recognized as a model of excellence — designated the number 3 top biologic plant in the world out of 1,000 plants across the globe in 2011. Making quality the top priority from the start of the manufacturing process is one of the best ways to protect patients from a potential supply disruption. Amgen has put in place the appropriate quality checks and rigorous standards to ensure the reliable supply of the medicines it makes, and continues to work tirelessly every day to deliver on its commitment to “every patient, every time.”

Amgen’s approach to providing a continuous supply of biologic therapies has FOUR key elements:

1

PREVENTION

which includes ensuring exemplary regulatory compliance, robust quality management processes, operational excellence, supply chain security, infrastructure investments, and business continuity planning

2

TECHNOLOGY

to enhance product purity and the robustness of the manufacturing process

3

INVENTORY MANAGEMENT

to ensure we have the right quantities of the product housed in diverse geographic locations

4

REDUNDANT MANUFACTURING

capacity in multiple geographic locations and back-up suppliers for raw materials