Breaking News

Aptuit OffersBiodistribution Studies

February 8, 2013

Expands preclinical research services

Aptuit LLC now offers 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). The company’s biodistribution studies are run in parallel with safety and toxicology studies to evaluate the persistence, tissue distribution and clearance of GTMPs, including viral vectors.
Stuart Needleman, Aptuit’s president and chief operating officer, said, “The offering is well suited to small and medium-sized Biotechs, CMOs and clinical CROs with limited research capabilities. These companies also benefit from Aptuit’s extensive regulatory experience and compliance with FDA and EMA mandates.”
The biodistribution studies are conducted by scientists in the Preclinical Biosciences group at The Aptuit Center for Drug Discovery & Development in Verona, Italy.
Mr. Needleman added, “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.”

blog comments powered by Disqus
  • Elemental Impurity Testing

    Elemental Impurity Testing

    Dr. Andrew Fussell, PANalytical ||January 28, 2016
    Advances in elemental impurity testing aid compliance with new USP requirements

  • Fit-For-Purpose Assay Development in Bioanalysis

    Fit-For-Purpose Assay Development in Bioanalysis

    Franklin Spriggs, Ligand Binding Assay Group Leader; Ashley Brant, Program Manager, AIT Bioscience||January 28, 2016
    The success of bioanalytical studies relies on the selection of the most suitable analytical method but the timeline of method development and types of analyses involved vary greatly.

  • Optimizing Collaboration Effectiveness in Alliance Partnerships

    Optimizing Collaboration Effectiveness in Alliance Partnerships

    Mary Jo Lamberti, Phil Birch, Ranjana Chakravarthy, Ken Getz, Tufts CSDD||January 28, 2016