Aptuit LLC Introduces Complementary Vision, a New Global Approach to CMC
Stuart Needleman, President and Chief Operating Officer, Aptuit LLC says, “It is an approach that encompasses all the services that precede and follow CMC in the target product profile. These services include: API Development & Manufacture; Qualitative/Quantitative Chemical, Physical and Biopharmaceutical Characterization of actives and dosage forms; Dosage Form Design, Development and Manufacturing for preclinical and clinical dosing; and the Development, Manufacturing and Testing of Inhaled Products such as Dry Powder Inhalers.”
Mr. Needleman explained that Aptuit looks at the big picture, and investigates many areas that are not usually considered because on the surface it appears that they may not be related to CMC. However, by broadening its outlook, Aptuit can be mindful of the findings that could become issues down the road. Mr. Needleman said, “Because we address potentially troublesome eventualities early on, we can mitigate risks, saving our customers time and money.”
It was stated that Complementary Vision drives integrated CMC services at The Aptuit Center for Drug Discovery & Development in Verona, Italy. By providing all aspects of drug discovery and development under one roof, including CMC, Aptuit scientists can apply cross-functional, collaborative thinking to CMC services.
Pieter Westerduin, Director of API Development at The Aptuit Center for Drug Discovery & Development in Verona, Italy, discussed the advantages of working with the Verona site. “When customers contract our fully integrated CMC offering, they can count on a combination of in silico, in vitro and in vivo services. These services substantiate the design, development and selection of the most effective dosage form for the intended clinical use throughout the application of biopharmaceutics from early to late development stages. They can anticipate reduced time and costs due to less trial and error and more accurate results. These strengths are based on the vast, long standing expertise of our CMC experts and knowledgeable scientists. We also offer a comprehensive review process for generic drugs, as well as exceptional expertise in API process development. These capabilities all come together to provide great value for our customers who know they can trust our vast experience and a working environment that is conducive to transparency and openness.”
Mr. Westerduin added that Aptuit CMC services are also available from other European facilities and from U.S. sites on a standalone basis or integrated with capabilities from other Aptuit facilities. For example, Aptuit has long-established, quality expertise in API manufacture and development from sites in the U.S. and the UK.
Mr. Needleman concluded, “There are many reasons why Aptuit is now an industry leader in CMC. Our fully integrated services in Verona are complemented by global teams of experts in key areas and we operate in a truly collaborative mindset. Our concept of Complementary Vision allows Aptuit to provide significant value to pharmaceutical manufacturers and CMC consultants, and we hope that both segments will want to learn more about our approach and take the opportunity to visit our global facilities.”
For more information, please contact Maria Garvey at Delfino Marketing either by phone at 914-747-1400 or by email: 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