Biological Medicines—Changing
the Practice of Medicine

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.

That's why Manufacturing Matters.

Learn more about the science of creating a biological medicine

How Biological and Small-Molecule Medicines Differ

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

See how biological and small-molecule medicines compare

Building a Biological Medicine


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

Experience matters.

View a typical biotechnology manufacturing process
Learn about the challenges of manufacturing biological medicines.

The Challenges in Manufacturing Biologics

Maintaining a consistent supply of safe and effective biological medicines requires expert staff, advanced science, and sophisticated and careful adherence to strict standards.7

Watch the "Challenges in Manufacturing Biologics" video

Expert Opinion
With Dr. Petricciani

I am collaborating with Amgen to improve understanding of how the efficacy, safety, and availability of biological medicines can be affected by the manufacturing process, and the importance of a robust quality control system.

Dr. Petricciani addresses questions about biological medicines
References
  1. Meibohm B. The role of pharmacokinetics and pharmacodynamics in the development of biotech drugs. In: Meibohm B, ed. Pharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies in Drug Development. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co.; 2006:3-13.
  2. Declerck PJ. Biologicals and biosimilars: a review of the science and its implications. GaBI J. 2012;1(1):13-16.
  3. Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1(1):1-11.
  4. Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28(6):1053-1058.
  5. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411-419.
  6. Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus. 2009;2(suppl 1):i27-i36.
  7. Walsh G. The drug manufacturing process. Biopharmaceuticals: Biochemistry and Biotechnology, Second Edition. Hoboken, NJ: John Wiley & Sons: 2003:93-187.