A little over a decade ago, the pharmaceutical industry was shaken when adulterated imported heparin caused death and injury. Investigation into these adverse events revealed that a similar but toxic compound was used to manufacture the culpable batches of blood thinning medication. This crisis served as an industry eye-opener to the need for increased supply chain security and transparency.
How did a lethal heparin formulation make it past regulated checkpoints and into the clinic? And how can the industry prevent such an occurrence from happening again?
Biologics demand heightened material control
In the heparin case, the answers narrowed toward a need for more robust raw material standards, traceability, incoming material testing capabilities, documentation, and diversity of supply.
To maintain the bench-to-bedside continuum, companies must critically examine their supply chains and act to mitigate exposure to adverse supply events. Qualifying two suppliers, increasing capacity, implementing a scorecard methodology for strategic suppliers, and surveying suppliers for their number of production lines are all important ways to guarantee steady supply of materials and technologies – but we must ensure close attention is also paid to raw materials.
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened material controls. Raw materials like cell culture media can have a major impact on the robustness of the biomanufacturing process and, ultimately, on the drug itself.
Raw material origin and trace element compositions are useful indicators of product performance, giving information on whether the production process needs modification. A thorough understanding of raw material characteristics and their effects on product performance will provide higher titers and yield, guarantee quality, and control costs.