January 1 was more than just the start of a new year for USP in 2018. It was the implementation date of two new standards designed to safeguard the global drug supply from potentially toxic impurities – mercury, cadmium, arsenic, and lead, for example.
The quality of medicine and how it’s delivered to patients is fundamental to treating illness and maintaining health. At USP, we help build a safety net across the drug industry and healthcare system to preserve the well-being of patients.
For patients needing a bone marrow or stem cell transplant, successful treatment often depends on finding a viable transplant sample with the right amount of hematopoietic stem cells (HSCs) to rebuild the patient’s immune system.
When patients are administered biological treatments created from their own bodies - autologous regenerative medicines - every second counts. Quality and purity can’t be compromised.
By the year 2020, biopharmaceuticals are estimated to account for 50% of the most successful pharmaceutical products. (1)(2) Biologics, such as recombinant therapeutic proteins, vaccines, blood components, and regenerative medicines are growing faster than any other segment of medicines.
Highly complex biologics such as proteins, monoclonal antibodies, and cell and gene therapies increasingly fill biopharmaceutical pipelines across a range of therapeutic indications.
Building the marketplace for generic medicines is a key strategy to containing drug costs in the US, one that USP actively supports through our standards-setting work.
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.