Quality Assurance

Biotechnology supply

We check. Then we check again

At Amgen, we are focused on a common goal: to make sure high-quality medicines get to every patient, every time. We achieve this in part by capitalizing on our 100-country-strong infrastructure, in which all facilities follow the same processes to:

  • Produce the highest-quality medicine
  • Deliver a reliable supply of medicine

Focused on ensuring quality

Protecting patients is paramount. We invest heavily in risk mitigation on all levels to serve our patients and care providers, so we can immediately correct course should any issues arise. From the lab to the bioreactor to final delivery, biosimilars are typically subjected to over 250 quality checks to ensure their similarity to the respective reference products.1

Amgen employs two primary types of systems to ensure quality:

  • Quality Management Systems that ensure adherence to normal variability standards
  • Quality by Design Principles that are part of important processes developed to ensure high-quality, safe, and compliant medicines2,3

Not only that, we take complete responsibility for our medicines after they leave our facilities, with effective monitoring standards in place to ensure:

  • Rapid traceability
  • Monitoring of safety events
  • Accurate identification of specific biosimilars used by individual patients

An outstanding record of reliable supply

At Amgen, we make medicines for serious illnesses and chronic conditions that deeply affect patients’ lives. We know it is imperative patients receive an uninterrupted supply of medicine and that gaps in supply can have serious consequences.

BioEngage
Reliability of drug supply is critical

Potential impact of drug shortages may include4:

Drug rationing and need to prioritize patients

Time burden involved in managing shortages

Errors caused by inexperience with alternatives

Better supply chain performance can5:

Improve drug access, delivering reliable health care

Improve safety, reducing human and financial burden of medication errors

At Amgen, we make medicines for serious illnesses and chronic conditions that deeply affect patients’ lives. We know it is imperative patients receive an uninterrupted supply of medicine and that gaps in supply can have serious consequences.

Amgen implements product security programs to help
ensure reliable supply of its medicines to patients6

To maintain reliability, we depend on our state-of-the-art manufacturing and distribution infrastructure to ensure a consistent supply of high-quality biosimilars across the globe. We implement product security programs that eliminate shortages and help ensure quality.

It is because of measures like these that we have one of the best records for lack of drug shortages in the pharmaceutical industry.7

Total number of drug shortages 2007-20177,*

*Data collected from the American Society of Health-System Pharmacists.

References: 1. EuropaBio. Guide to Biological Medicines: A Focus on Biosimilar Medicines. www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf. Published 2012. Accessed April 23, 2018. 2. Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol. 2009;27:26-34. doi:10.1038/nbt0109-26 3. Jameel F, Khan M. Quality-by-design as applied to the development and manufacturing of a lyophilized protein product. Am Pharm Rev. www.americanpharmaceuticalreview.com/Featured-Articles/117782-Quality-by-Design-as-Applied-to­-the-Development-and-Manufacturing-of-a-Lyophilized-Protein-Product/. Published December 1, 2009. Accessed May 4, 2018. 4. US Government Accountability Office. Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability. GAO-14-194. www.gao.gov/assets/670/660785.pdf. Published February 10, 2014. Accessed April 26, 2018. 5. Ebel T, George K, Larsen E, Shah K, Ungerman D. Building New Strengths in the Healthcare Supply Chain. McKinsey & Company. www.mckinsey.com/-/media/mckinsey/dotcom/client_service/pharma%20and%20medical%20products/pmp%20new/pdfs/mckinsey%20white%20paper%20-%20building%20new%20strengths%20in% 20healthcare%20supply%20chain%20vf.ashx. Published January 2013. Accessed April 26, 2018. 6. Mica A, Mutomba M, Green L. Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider. GaBi J. 2013;2(3):136-143. 7. Data on file, Amgen; 2018.

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