Amgen biotechnology manufacturing quality iconQuality from the start

High-quality and reliable biotech manufacturing is every bit as important as scientific innovation. The significant investment Amgen has made in state-of-the-art manufacturing facilities, robust processes,1,2 and an experienced and engaged workforce reflects our unwavering commitment to excellence in biotech manufacturing.

Amgen maintains this commitment because seriously ill patients count on our medicines for their treatment. The characteristics of biologic medicines are closely related to manufacturing processes and environmental conditions.3 With this in mind, Amgen builds in quality, beginning with the design of medicines, all the way through to their development, manufacturing, and distribution to patients. We include more than 250 quality checks and perform in-depth analysis of our manufacturing performance to continuously improve it.4

  1. Amgen Continues Manufacturing Expansion with Additional $1 Billion Investment in Puerto Rico. Press release. February 2006.
  2. Amgen to Make Significant Investment in Manufacturing, R&D and Commercial Operations Expansion. Press release. January 2006.
  3. Herman AC, Boone TC, Lu HS. Characterization, formulation, and stability of Neupogen (Filgrastim), a recombinant human granulocyte-colony stimulating factor. Pharm Biotech 1996;9:303-328.
  4. Data on file, Amgen; 2014.
Amgen scientist preparing samples in the Chemistry lab

Quality in action

Quality by Design (QbD) is a set of principles adopted by Amgen to ensure quality control in the manufacturing process. It's part of a regimen of important processes Amgen has developed to produce and deliver high-quality products that are both safe and compliant with regulatory requirements.