Greenwich CT, February 6, 2013 – Stuart Needleman, President and Chief Operating Officer, Aptuit LLC, announced the availability of GLP-qPCR Biodistribution Studies required as part of the preclinical development study package for application in First In Man (FIM) of Gene Therapy Medicinal Products (GTMPs). At Aptuit, Biodistribution Studies are run in parallel with Safety and Toxicology Studies and are used to evaluate the persistence, tissue distribution and clearance of GTMPs, including viral vectors.
Mr. Needleman said that the offering is well suited to small and medium size Biotechs, CMOs and clinical CROs with limited research capabilities. He stated that these companies also benefit from Aptuit’s extensive regulatory experience and compliance with FDA and EMA mandates.
Biodistribution Studies are conducted by scientific specialists in the Preclinical Biosciences group at The Aptuit Center for Drug Discovery & Development in Verona, Italy.
Corrado Corti, PhD, Head of Molecular and Cellular Biology at The Aptuit Center for Drug Discovery & Development, said that the Preclinical Biosciences group has extensive experience with GTMPs and viral vectors. They are accustomed to a large pharmaceutical working environment and have a strong record in quality molecular studies.
Dr. Corti emphasized that customers have unique advantages when they choose Aptuit’s fully integrated services for the development of GTMPs. “The benefits are numerous when biodistribution studies are combined with general toxicity studies, allowing for the integration of biodistribution evidence with toxicity study endpoints. Indeed, the high integration of the molecular and in vivo studies conducted in parallel allows data comparison in real time, offering the possibility to fine tune ongoing studies. Aptuit’s fully integrated offering means that Biodistribution studies might also be performed on large animal species with a reduced number of animals, thereby bridging the preclinical development of GTMPs to FIM. Of course, we offer Biodistribution services on a standalone basis as well (e.g. clinical derived samples) in order to provide customers full access to our technical platforms to meet their needs and expectations.
The fact that our preclinical development studies include immuno-assays, in vivo models and post mortem evaluation, all conducted in parallel from one site in a fully integrated approach, is a real advantage to customers.”
Mr. Needleman summed it up by saying, “The single site advantage is the springboard for multiple benefits. We offer the flexibility in running studies under both GLP and non-GLP parameters; the possible use of non-human subjects from new facilities; flexibility, rapid response and adaptation during development and real time parallel data for the entire preclinical development study package.”
For more technical information, please contact Corrado Corti by phone at +39 045 8219576 and by email at corrado.corti@aptuit.com. For press information, or to arrange an interview, please contact Maria Garvey, Delfino Marketing at 914-747-1400 or maria@delfino.com.
Aptuit LLC provides the most complete set of integrated early to mid-phase development services in the pharmaceutical industry. Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Sterile Fill Finish & Formulation Development, Oral Dosage Form Development & Manufacture, Clinical Sciences, Consulting and Aptuit INDiGOÒ (a program that accelerates drug development) are offered as stand alone or integrated services. Fully integrated drug discovery & development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. The company maintains five global facilities with approximately 800 employees in Europe and the United States, and has a strategic relationship with Laurus Labs in India. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.
For more information about Aptuit, visit www.aptuit.com
