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.
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.
Establishing the suitability of packaging systems for pharmaceutical products is critical. With many new materials and applications entering the marketplace, testing procedures for these systems need to be revised regularly to make sure quality attributes are considered. To that end, USP has started an effort to modernize its packaging standards. Learn more.
Nanomedicine—the use of nanoscale materials and technologies to treat diseases at the molecular level—has shown promising results in patient care, particularly in oncology. While this potential has led to increased research, there are challenges surrounding nomenclature, characterization and environmental impact. Learn how you can collaborate with USP to help determine a path foward.
Dr. Maya Guncheva, a USP visiting scientist from Institute of Organic Chemistry, Centre of Phytochemistry at the Bulgarian Academy of Sciences provides a brief account of her research interests, what brought her from Bulgaria to Rockville, and the highlights of her experience at USP.
In LMICs, the availability of medicines manufactured locally that do not meet quality standards is a leading cause of treatment failure and adverse events in patients and is undermining public health interventions. But where do things go wrong during pharmaceutical manufacturing in LMICs that give rise to this problem? Learn more.
Desmond Hunt, Ph.D., USP’s Senior Scientific Liaison, provides insight into metal packaging systems for drugs and how USP standards can support quality in this field. Dr. Hunt works closely with USP’s Expert Committee on Packaging and Distribution—the volunteer experts who serve as key decision-makers in the USP standards-setting process. Learn more.
Over-the-counter (OTC) medicines, drugs available to consumers/patients without a prescription, play an important role in our modern healthcare system. An upcoming Consumer Healthcare Products Association workshop highlights how USP collaborates with key stakeholders to help address specific needs in OTC manufacturing and testing related to drug quality. Learn more.