The development of biological medicines has changed how doctors treat certain serious illnesses, helping millions of people in their fight against cancer, blood disorders, diabetes, kidney, inflammatory, and neurological disorders.1
Building confidence in the safety and supply of biological medicines starts with a deeper understanding of how these treatments are made. After all, there's so much at stake.
The manufacturing process is important for all drugs, but especially for biological medicines, which can be more complex structurally and more difficult to characterize, produce, and reproduce than most small-molecule medicines.2,3
These differences are important to take into account when understanding how the manufacturing process for a biological medicine can have an impact on product efficacy, quality, supply, and ultimately patient care.4-6
Manufacturers of biological medicines should have sophisticated manufacturing technology and cutting-edge quality management systems that meet necessary regulatory requirements.7
Significant skill, experience, vigilance, and commitment to quality are critical to ensure a reliable supply of biological medicines for patients.7