Quality Processes for Safe Medicines

Investing in high-quality biologic manufacturing.

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 as part of 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.

Additionally, Amgen has adopted the Quality by Design (QbD) principles, a proactive approach to product design which further integrates quality control into the manufacturing process.4 For QbD, a set of principles are utilized throughout the design process.  The product and process knowledge base must include an understanding of:

  • variability in raw materials,
  • the relationship between a process and product’s critical quality attributes (CQAs), and
  • the association between CQAs and a product’s clinical properties.

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.5

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