GVK Biosciences CEO Manni Kantipudi said the firm sought the approval after "several" undisclosed customers asked it to extend its chemistry services to include the technique. "We listened to [these] customers and set up [this] facility," he said.
Though the clearance allows GVK Biosciences' Type III-accredited, GLP-compliant lab to handle and synthesize only isotopes 3H and 14C, the CRO was previously "permitted to handle" isotopes 14C, 3H, 32P, 33P, 35S, 125I and 51Cr. The isotope synthesis-services facility became operational during the summer.
Officials from GVK Biosciences were not immediately available for comment.
In drug discovery, isotope labeling can be used in several ways. "Isotopically labeled compounds are required for research and development activities in the pharmaceutical industry, and especially in the area of ADME [absorption, disposition, metabolism and elimination] studies of new drug candidates," according to John Allen, founder and chief executive of Paris-based Allen Isotope Labelling Consultancy.
It is in metabolic and pharmacokinetic research that isotope labeling plays one of its biggest roles as a drug-discovery and -development tool. "Understanding the metabolic and pharmacokinetic fate of a drug in humans is a key factor in its development and registration, as well as in the elaboration of new therapeutic agents," Jacobo Iglesias, Lekha Sleno and Dietrich A. Volmer write in the November issue of Current Drug Metabolism.
"To carry out these studies, stable isotope labeling techniques have been effectively used by drug-metabolism scientists and toxicologists in order to gain better understanding of drugs' disposition, bioavailability and toxicity in in vivo studies."
In addition, farther up the pipeline isotope labeling can be used in pharmacogenomic applications to test for relevant proteins in a proteome, or the entire complement of proteins expressed in a genome.
Instruments GVK Biosciences currently uses as part of its isotope-synthesis and radio isotope research applications comprise β-RAM INUS 5-online radio detector with high-performance liquid chromatography, liquid scintillation counters, radio TLC detectors and collimators, and contamination monitor instruments, according to the company's website.
With 11 research facilities spread throughout Hydrabad, Chennai, Ahmedabad, Haryana and Mumbai, GVK Biosciences serves nearly 200 clientele worldwide, including pharmaceutical, biotechnology, agricultural and life-sciences companies, and academic and research institutions.
The CRO works with companies engaged in drug discovery and development, agro and veterinary chemicals, cosmetics, perfumery and specialty studies. Its discovery and development services comprise chemistry, biology, informatics, clinical research, clinical pharmacology and process R&D.
GVK Biosciences is part of the GVK Group, an infrastructure developer inIndiathat specializes in energy, resources, airports, transportation, hospitality and life sciences.