Advanced manufacturing techniques, such as pharmaceutical continuous manufacturing (PCM) and 3D printing could increase the speed of medicines’ production from weeks to days and minimize manual interventions that could introduce errors.
USP is actively collaborating with stakeholders to help advance standards in ensuring the quality of advance manufacturing techniques, such as PCM, and exploring technologies, such as 3D printing and digital therapeutics, to understand the future modalities of medicine and personalization that meets patients’ needs.
As digital therapeutics become a reality for patients with diabetes, asthma, heart disease, and other serious conditions, considerations around safety and quality are essential to delivering positive health outcomes. Read more about the role of public standards in assuring the quality of digital therapeutics:
USP is also exploring the use of various analytical technologies for testing the quality of medicines, dietary supplements and foods, including rapid microbial testing, endotoxin testing, bioassay and quantitative nuclear magnetic resonance spectroscopy (qNMR).
In addition, USP is exploring:
- Packaging standards that need to evolve with new materials that are developed and new drug delivery methods:
- Analytical technologies that can be used to modernize documentary and reference standards to address challenges like cell and gene therapy standards and digital therapeutics, for example:
- Ultra-high-performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS): A powerful method for identifying or verifying the chemical structure of a sample and quantifying it against a USP Reference Standard.
- Process analytical technology (PAT): A system for designing, analyzing, and controlling manufacturing by measuring the quality and performance data of raw and in-process materials to help ensure final product quality.
- Rapid microbial tests (RMT): Methods that detect microorganisms in immediate-use or short shelf-life therapeutic products, ideally in real time or less than 24 hours before patient administration.
- Endotoxin tests: Methods of evaluating injectable products to help ensure that they are free from harmful levels of bacterial toxins found in manufacturing.
