Biologic medicines are highly sensitive to factors like temperature and pH, making them more difficult to produce on a large scale. Even minor alterations in manufacturing conditions may lead to unwanted or unintended changes in the final product.1,2
Manufacturers of biologic medicines are responsible for monitoring all steps during product development to ensure that the medicine is pure, has the desired strength, and is stable. Once the quality of the medicine has been verified using established tests, the medicine is packaged for use. Since biologic medicines are very sensitive to their environment, proper handling is critical in order to maintain production of a reliable, quality product.3
Problems or interruptions to the manufacturing process of biologic medicines may not only affect quality and safety, but could also lead to delayed supplies and distribution of urgently needed medicines. Along with regulators, manufacturers have a responsibility to ensure strategies are in place to minimize incidences of drug shortages and possible supply disruption.1
References: 1. Grampp G, Ramanan S. Managing unexpected events in the manufacturing of biologic medicines. BioDrugs. 2013;27:305-316. 2. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419. 3. Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6:469-478.