Quality Processes for Medicines

Investing in high-quality manufacturing.

The significant investment Amgen has made in state of the art manufacturing facilities, robust processes, and an experienced and engaged workforce reflects our unwavering commitment to excellence in biotech manufacturing.1


Amgen maintains this commitment because seriously ill patients count on our medicines as part of their treatment. The characteristics of biologic medicines are closely related to manufacturing processes and environmental conditions. Because of this, Amgen builds in quality from the start of design, and we include more than 250 quality checks and perform in-depth analysis of our manufacturing performance to continuously improve it.2

Additionally, Amgen has adopted the FDA-recommended Quality by Design (QbD) principles, a proactive approach to product design, which further integrates quality control into the manufacturing process. QbD involves:3

  • Enhanced product understanding (identifying critical quality attributes [CQA] of product) 
  • Enhanced process understanding (determining how the attributes of raw materials and process parameters impact CQAs)
  • Risk management and control strategy to ensure product continuously meets quality standards 

By utilizing QbD principles and adhering to regulatory requirements, Amgen follows a systematic approach to the development of its medicines that begins with predefined objectives and emphasizes extensive product knowledge, process understanding, and process control, based on sound science and quality risk management.4

Biologic medicines typically have 250 in-process quality tests during manufacturing compared to small-molecule drugs, which typically include 50 tests.2

References:

  1. Amgen continues manufacturing expansion with additional $1 billion investment in Puerto Rico [press release]. Thousand Oaks, CA: Amgen; February 2, 2006. http://www.amgen.com/media/media_pr_detail.jsp?year=2006&releaseID=812284. Accessed December 21, 2014.
  2. EuropaBio. Guide to biological medicines: a focus on biosimilar medicines. Brussels, Belgium.
  3. US Department of Health and Human Services. Q8(R2) pharmaceutical development. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073507.pdf. Accessed November 23, 2016.
  4. Jameel F, Khan M. Quality-by-design as applied to the development and manufacturing of a lyophilized protein product. Am Pharm Rev. 2009. http://www.americanpharmaceuticalreview.com/Featured-Articles/117782-Quality-by-Design-as-Applied-to-the-Development-and-Manufacturing-of-a-Lyophilized-Protein-Product/. Accessed December 21, 2014.