Fortrea, Emery Pharma Team Up On Rifampin Safety Testing For Clinical Trials
BUSINESS
KUALA LUMPUR, June 25 (Bernama) -- Fortrea, a global contract research organisation (CRO), has announced a strategic collaboration with Emery Pharma to provide rapid impurity testing of rifampin used in drug-drug interaction (DDI) studies.
In a statement, Fortrea said the partnership will enable testing for 1-methyl-4-nitrosopiperazine (MNP), a nitrosamine impurity, ensuring levels remain below the acceptable intake limit set by the United States Food and Drug Administration (FDA).
Fortrea Chief Medical Officer and President of Clinical Pharmacology Services, Dr Oren Cohen said the partnership would help accelerate early-phase clinical trials by providing certified rifampin for use in DDI studies and enhance data quality.
'This collaboration reflects our shared commitment to smarter study design and greater participant safety,' he said.
Meanwhile, Emery Pharma Chief Executive Officer, Dr Ron Najafi said the collaboration would contribute to safer and more efficient drug development, adding that the company specialises in solving complex analytical challenges in compliance with regulatory standards.
Fortrea selected Emery Pharma based on its expertise in analytical and bioanalytical testing under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) standards.
The new testing service is now available to Fortrea customers involved in clinical pharmacology trials, with study designs tailored to FDA requirements.
Rifampin, a widely used antibiotic and a preferred agent in DDI studies due to its safety and tolerability, had previously come under scrutiny after the FDA found that MNP levels in tested batches exceeded acceptable limits.
However, the agency revised its guidance in 2023, allowing the continued use of rifampin under updated thresholds.
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Peanuts and peanut butter can be a key dietary element for GLP-1 users because peanuts contain significant amounts of protein, fiber and healthy fats. Research suggests those three macronutrients can help support the body's natural GLP-1 response.2 In addition, the Cleveland Clinic recently shared that 'eating peanuts may help you maintain a healthy weight and avoid having obesity.3,4″ Peanut Protein PlussesAccording to the United States Department of Agriculture Nutrient Database, a single serving of peanuts (about 1 ounce) packs seven grams of protein, which is more than any other nut5,6. In addition, peanuts are a plant-based protein, and a long-term study found that swapping one daily serving of animal protein for plant protein (like peanuts or peanut butter) decreases the risk of developing type 2 diabetes.7 Another benefit of peanuts is that they are packed with 19 vitamins and minerals, including niacin, vitamin E and magnesium. 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Based in Albany, Ga., The Peanut Institute is a non-profit organization supporting nutrition research and developing educational programs to encourage healthful lifestyles that include peanuts and peanut products. The Peanut Institute pursues its mission through research programs, educational initiatives and the promotion of healthful lifestyles to consumers of all ages. As an independent forum, The Peanut Institute is uniquely positioned to work with all segments of the food industry, the research community, academia, consumer organizations and governmental institutions. Sources 1. Neeland IJ, Linge J, Birkenfeld AL. Changes in lean body mass with glucagon-like peptide-1-based therapies and mitigation strategies. Diabetes Obes Metab. 2024 Sep;26 Suppl 4:16-27. doi: 10.1111/dom.15728. Epub 2024 Jun 27. PMID: 38937282.2. Mozaffarian D, Agarwal M, Aggarwal M, Alexander L, Apovian CM, Bindlish S, Bonnet J, Butsch WS, Christensen S, Gianos E, Gulati M, Gupta A, Horn D, Kane RM, Saluja J, Sannidhi D, Stanford FC, Callahan EA. Nutritional priorities to support GLP-1 therapy for obesity: A joint Advisory from the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and The Obesity Society. Obesity (Silver Spring). 2025 May 30. doi: 10.1002/oby.24336. Epub ahead of print. PMID: 40445127.3. Petersen KS, Murphy J, Whitbread J, Clifton PM, Keogh JB. The Effect of a Peanut-Enriched Weight Loss Diet Compared to a Low-Fat Weight Loss Diet on Body Weight, Blood Pressure, and Glycemic Control: A Randomized Controlled Trial. Nutrients. 2022 Jul 21;14(14):2986. doi: 10.3390/nu14142986. PMID: 35889947; PMCID: PMC9318508.5. 'USDA Food Composition Databases.' U.S. Department of Agriculture. Search for 'legumes and legume products, 100 g,' March 12, 2018. 6. 'USDA Food Composition Databases.' U.S. Department of Agriculture. Search for 'nut and seed products, 100 g,' March 12, 2018. 'Dietary Protein Intake and Risk of Type 2 Diabetes in US Men and Women.' V.S. Malik et al. American Journal of Epidemiology. 2016, vol. 183, no. 8, pp. 715-28. 8. Morris MC, Evans DA, Bienias JL, Scherr PA, Tangney CC, Hebert LE, Bennett DA, Wilson RS, Aggarwal N. Dietary niacin and the risk of incident Alzheimer's disease and of cognitive decline. J Neurol Neurosurg Psychiatry. 2004 Aug;75(8):1093-9. PubMed PMID: 15258207; PubMed Central PMCID: PMC1739176.9. U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th Edition. December 2020.10. Larsson SC, Orsini N, Wolk A. Dietary magnesium intake and risk of stroke: a meta-analysis of prospective studies. Am J Clin Nutr. 2012 Feb;95(2):362-6. doi: 10.3945/ajcn.111.022376. Epub 2011 Dec 28. PubMed PMID: 22205313.11. Larsson SC, Wolk A. Magnesium intake and risk of type 2 diabetes: a meta-analysis. J Intern Med. 2007 Aug;262(2):208-14. Review. PubMed PMID: 17645588.12. 'Dietary Guidelines for Americans 2015-2020, 8th Edition.' U.S. Department of Agriculture, December 2015. US Department of Agriculture, Agricultural Research Service, Nutrient Data Laboratory USDA National Nutrient Database for Standard Reference, Release 28. [(accessed on 13 February 2019)]; Version Current: September 2015, Slightly Revised May 2016. Available online: Nguyen SM, Tran TDC, Tran TM, Wang C, Wu J, Cai Q, Ye F, Shu X-O. Influence of Peanut Consumption on the Gut Microbiome: A Randomized Clinical Trial. Nutrients. 2024; 16(19):3313. Arya SS, Salve AR, Chauhan S. Peanuts as functional food: a review. J Food Sci Technol. 2016 Jan;53(1):31-41. doi: 10.1007/s13197-015-2007-9. Epub 2015 Sep 19. Review. PubMed PMID: 26787930; PubMed Central PMCID: PMC4711439. 16. Ajala O, English P, Pinkney J. 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