EPM News Update
Stuart Needleman, President and Chief Operating Officer, Aptuit, has announced that the company provides integrated bioanalytical services for biotherapeutics, such as large molecules, proteins and enzymes, from The Aptuit Center for Drug Discovery & Development in Verona, Italy.
When making the announcement, Needleman cited Aptuit’s substantial range of pharmacology expertise and capabilities to support the development of biologicals for the translational disease relevant models, including oncology, inflammatory diseases, metabolic disorders such as diabetes, psychiatry and neurology, neurodegeneration, pain and infections. He said that the company’s expertise in immunological biology in human and preclinical species has enhanced Aptuit’s reputation for quality work related to high risk compounds.
John Chappell, Manager, Applied Immunology and Biopharmaceutical Development, stressed that Aptuit’s integrated discovery and preclinical services provided from the Verona location employ sophisticated equipment and detection technologies. “The breadth of our capabilities bring added value to clients who have been dealing with several suppliers to get the data they need,” he said. “When clients choose to partner with Aptuit from our single, integrated site, they experience convenience, time and cost savings and, importantly, an exceptional level of quality performance that is the result of our well established collaborative expertise.”
It was also noted that Aptuit’s capabilities in bioanalytical therapeutics can serve as part of Aptuit INDiGO, an accelerated route to First In Man, as short as six to 12 months, much less than the industry standard and fully compliant with US and European regulatory guidelines.
Needleman added: “Aptuit’s Glasgow facility also has a legacy of expert bioanalytical services in sterile fill finish for Phase I studies that may be integrated with the competencies of our other global facilities. All of our facilities maintain the highest quality protocols that are consistent from site to site. Within the Aptuit organisation, expert consultancy in biotherapeutics strategy and regulatory support are available. Consultants with real world experience are accessible throughout the development cycle, including assistance during the complex regulatory process. EU and US regulatory submissions can be written by our technical experts and submitted electronically or in paper or hybrid forms as needed.”
Aptuit LLC, john.chappell@aptuit.com, www.aptuit.com.