EuTech Scientific Services, Inc.’s (EuTech) experienced team has worked hand-in-hand with IHP Therapeutics (IHP) to perform a complete characterization of their biological drug IHP-009 to ensure that it meets FDA regulations.
The characterization data submitted to the FDA resulted in IND approval of IHP-009 in March of 2021.
Characterization of biologics is different than small molecules that has a well-defined structure. Biologics are very large in size, and their structure identifications have to include inherent variability associated with being of biological origin.
“Our team is honored to be a trusted lab of choice to perform complete characterization of a biological drug in a timely manner to ensure sensitive worldwide Covid-19 cure development progress,” said Dr. Raghvendra Sahai, President, ARL-EuTech Scientific Services, Inc.
About ARL-EuTech Scientific Services
Founded in 1994, EuTech partners with Pharmaceutical and Medical device companies in their Drug Development and quality assurance programs strictly adhering to FDA’s GLP/GMP guidelines. It is also DEA licensed Schedule (I-V), and extends services to dietary supplements, nutraceuticals and raw material suppliers. It has helped several pharma companies in detailed analysis of raw materials, API, excipients becoming their formulation development partner.
Pharmaceutical companies for the last two decades have utilized EuTech to ensure that their packaging is safe, and all the extractable leachable data meets FDA guidelines, further performing all the required testing for each lot release. In June 2021, EuTech became a member of the Tentamus family of companies, joining hands with ARL to become ARL-EuTech, offering its pharmaceutical clients better and more comprehensive services.
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan, India and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrosciences, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 80 locations worldwide. More than 3,000 highly-trained staff members work in over 3 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
Tentamus Group GmbH
An der Industriebahn 5
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
President and CEO ARL-EuTech Scientific Services, Inc.
Telefon: +1 732 249 1600