As science and technology continuously evolve, so must quality standards. This is as true today as it was when USP was founded nearly 200 years ago. In the 19th century, spectrometry was introduced as a new way to assess molecules, and was adopted into standards as the technology matured. Today, we continue to explore new technologies to consider their potential implications on quality standards.
Our collaborations with a diverse set of organizations, academics, and researchers are key to USP’s work envisioning the future of quality – including exploring the quality implications of new approaches, such as 3D printing of medicines, continuous pharmaceutical manufacturing, and digital therapeutics that use software as therapy.
Bridging from batches to continuous manufacturing
“The pharmaceutical industry is beginning to adopt continuous manufacturing approaches, which promise to improve flexibility and efficiency, compared to traditional “batch” manufacturing methods. Of course, new technologies bring new quality challenges. USP is collaborating with experts from academia and industry to best understand the implications on medicines quality of this complex manufacturing approach.
That’s why USP launched our Pharmaceutical Continuous Manufacturing (PCM) Initiative this year -- to help ensure the quality of medicines that are manufactured in a continuous process, as this approach becomes more broadly adopted by industry.”
Chief Science Officer
Exploring quality needs for new technologies
“Exciting new technologies are creating treatment options for patients with certain conditions -- such as attention deficit hyper activity disorder and substance dependency -- that are based entirely on software. This means that instead of taking medicine, a patient can interact with an app on his or her phone or tablet to achieve positive clinical outcomes. The FDA has recently approved several of these digital therapies, which treat substance use disorders, type 2 diabetes, respiratory disease, schizophrenia and other chronic conditions.
Along with the Digital Therapeutics Alliance, we co-hosted a roundtable discussion with USP experts and leading companies in the digital therapeutics field. Through this convening and our ongoing work we are exploring the meaning of quality in the context of these therapies and how quality standards can be applied to digital therapeutics.”