NSF Launches Morphologically-Directed Raman Spectroscopy (MDRS) In-Laboratory Technology Services

NSF, a leading public health and safety organization, now offers specialized research and analysis services based on Morphologically-Directed Raman Spectroscopy (MDRS) technology. The MDRS services include statistically significant component-specific particle size and morphology analysis, in vitro bioequivalence evaluation of pharmaceuticals and formulation particle size reverse engineering studies.

The MDRS technology is recognized and recommended by the US Food and Drug Administration (FDA). Companies utilizing MDRS technology for the research and production of nasal suspension spray generics can reduce compliance risks, respond quickly to market demands and improve research and development efficiency and product quality.

“MDRS technology helps generic drug companies save time and money spent on clinical trials when applying for FDA approvals,” said Michael Hidock, Director, NSF. “Additionally, the technology can help companies improve quality and efficiency in developing the drugs, as MDRS meets the research requirements for drug particle size outlined in the Technical Guidance for Nasal Suspension Spray’s PSG issued by the FDA.”

NSF’s MDRS services are conducted in its Shanghai lab, which has advanced instruments and equipment and has developed accurate and reliable analytical methods. It has also established an efficient scientific testing system covering effective sample dispersion, automated particle collection and image processing, precise Raman spectral identification, and quality system control. The MDRS technology services provided by NSF can bring significant advantages to nasal spray companies in the development of generics and local innovations:

• Reducing reliance on clinical trials and accelerating the drug approval process in the US.
• Assisting companies in improving the efficiency and quality of local innovative drug development.
• Minimizing the costs and complexities associated with drug development and market entry.
• Providing comprehensive and efficient support.

MDRS is a multidimensional characterization technology that combines automated static imaging of particles with Raman spectroscopy capabilities. It accurately captures images of individual particles using optical microscopy for size and morphology analysis. Subsequently, single-point Raman spectral measurements are performed on each particle to obtain chemical characteristics. With this technology, only one test is needed on pharmaceuticals containing active pharmaceutical ingredients (APIs) and excipients to obtain the specific particle size and shape distribution of the APIs.

The FDA has provided clear recommendations for evaluating bioequivalence for nasal spray products. Certain nasal formulation drug varieties may be exempt from clinical endpoint studies if they are identical to reference drugs in formulation composition, dosage and delivery device. MDRS technology further determines the particle size distribution consistency between the generic and reference drugs, determining the exemption status.

“NSF has deep technical expertise in providing comprehensive compliance analysis, testing and research services to pharmaceutical companies,” added Hidock. “We are proud to contribute to the life sciences sector with MDRS technology, with the hopes of accelerating quality and time to market for pharmaceutical companies delivering life-enhancing medicines.”

NSF is an independent, global services organization dedicated to improving human and planet health for more than 80 years by developing public health standards and providing world-class testing, inspection, certification, advisory services and digital solutions to the food, nutrition, water, life sciences and consumer goods industries. NSF has 40,000 clients in 110 countries and is a World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Medical Device Safety.

NSF provides world-class services, solutions and certifications across the product lifecycle for clients in the pharmaceutical, biotech, medical device, IVD and combination product industries. Our certifications ensure drugs and devices meet high safety and quality standards, with ex-regulators verifying compliance to assure consumers of product integrity. Our expert team of leaders support companies across the world in navigating an ever-evolving matrix of regulations and industry challenges to deliver lifesaving and life-changing medical products and pharmaceuticals to patients.