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Biologics Manufacturing Quality and Reliability

Manufacturing Quality and Reliability

Biologic medicines are large, complex molecules often 200 to 1,000 times the size of small molecule drugs, such as aspirin, which are chemical compounds delivered in the form of a pill, tablet, or capsule. Biotechnology medicines are too large and intricate to be made using chemistry alone. They are made in living organisms and are highly sensitive, making them significantly more difficult to manufacture.

Amgen is an expert in biologics manufacturing. We have been at the forefront of the medical biotechnology revolution that started in the 1980s, helping invent the processes, methods and technologies that built the global biotechnology industry.

Fulfilling our mission to serve patients means ensuring that all Amgen medicines meet high-quality standards and are supplied reliably to patients around the world.

Amgen has an outstanding track record of reliably delivering medicines to patients who need them. Our highly skilled workforce, disciplined approach to operational excellence and risk mitigation efforts contribute to our commitment to ensure supply for “every patient, every time.”

Our global manufacturing network and significant long-term capital investments allow us to be confident in the face of an emergency or natural disaster and assure we consistently deliver reliability and value to our customers. The manufacturing of biologic medicines is very different from what scientists do when they are mixing chemicals for pills, tablets or capsules. Biologic medicines are grown in living cells. Each step is intricate, sensitive and often specific to a particular medicine, requiring significant skill and expertise. Even minor alterations may lead to changes in cell behavior and differences in the structure, stability or other quality aspects of the end product. Any of these differences have the potential to affect the treatment’s safety, efficacy and shelf life, and to increase the risk of an unwanted immune response.

Amgen was among the first companies to develop biologic medicines, and we invented and refined many of the processes in use throughout the biotech industry. We have developed an approach to operations that ensures consistent supply and high-quality consisting of five key areas:

Process Development

Process development brings a promising molecule from research to clinical trials and beyond. Process development designs the manufacturing process for the small-scale production needed for clinical trials, the commercial-scale process needed to serve a larger population, and the technology required to make the drug in different facilities around the world.


Our manufacturing teams are responsible for making our drugs, first for clinical trials and then, if we receive regulatory approval, on a commercial scale. The manufacturing process varies for each product.

Supply Chain

Our colleagues working in the supply chain teams ensure that we have the supply of quality raw materials needed to make our drugs—everything from chemicals and supplies to vials, devices, and packaging materials.


High-quality is maintained through every step of our process. We employ more than 250 quality checks and conduct in-depth analyses of our manufacturing performance to continuously improve it. We've also incorporated Six Sigma standards: a data-driven approach and methodology for eliminating defects that demands exacting precision.


Our engineering team is responsible for managing the life cycle of Amgen’s physical assets, such as buildings, equipment, utilities, and instruments. They work to continuously to improve these resources, so we can better serve our patients.