Regardless of whether it’s prescription or over-the-counter, the ingredients on a drug product label typically include one, maybe two, active pharmaceutical ingredients (APIs). The rest of the list is comprised of “inactive” ingredients (excipients) which in reality are far from inactive. Variability may be acceptable for products such as printer ink and paintballs, but not pharmaceuticals, making quality standards for excipients critical to ensuring consistent drug quality.
USP is exploring how its extensive expertise in developing quality standards for drug products and ingredients can contribute to pharmaceutical continuous manufacturing.
As more drug makers adopt pharmaceutical continuous manufacturing, new technological developments and operational demands are resulting from new partnerships among academic centers and industry leaders, particularly in the past two years. To this goal, USP recently formalized collaborations with Center for Structured Organic Particulate Systems (C-SOPS), a leader in research on PCM. Learn more about the opportunities in this field.