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Stuart Needleman, President and Chief Operating Officer, Aptuit LLC, announced the availability of bundled, comprehensive and integrated services in the antibacterial area from a single site, The Aptuit Center for Drug Discovery & Development in Verona, Italy.
When making the announcement, Mr. Needleman stated, “Our site in Verona, Italy, is unique in its ability to integrate discovery services with preclinical capabilities, going beyond what customers can expect from a typical CRO. Aptuit is pleased to give our customers a single site solution that combines high quality service with aggressive pricing.”
Mr. Needleman said that the bundled offering includes all antibiotic testing methods, as compliant with CLSI guidelines, such as MIC, MIC50, MIC90 and MBC. The vast number of services include, but are not limited to: Antifungal Susceptibility Testing; Cytotoxic Assays; Bio-Assays; Phenotyping and Genotyping of bacterial isolates; Single- and Multi-step Mutational studies; Synergy studies; Time-Kill studies; MoA studies; screening of compounds for efficacy using well established models; measurement of compound efficacy in disease animal models (rodents); and development of PK/PD model for prediction of human effective dose (i.e. Craig’s Model). Services also feature Translational biology methods that bridge preclinical to man, and are comprised of a multidisciplinary approach in collaboration with DMPK, Toxicology and Pathology and in vitro microbiology functions; differentiation packages based on the product compared to gold standard antibiotics; and consulting services for data interpretation, issue resolution and program progression.
Furthermore, customized whole-cell based High Throughput Screening (384 format), including cherry-picking of positive hits and confirmation of in vitro antibacterial activity by semiautomated concentration response curve determination is available at the Aptuit Center for Drug Discovery & Development in Verona.
Stand out advantages when compared to competitive offerings
Mr. Needleman emphasized that up to now, customers have relied on multiple suppliers for in vivo services and in vitro services. Mr. Needleman said, “When customers can count on all the antibacterial testing they need from a single site, it is a decided plus, creating a smoother, more comprehensive and more manageable process that goes a long way in mitigating risks.”
In emphasizing the Aptuit advantage in the competitive landscape, Mr. Needleman said that while some companies can provide general models from in vivo services, they do not offer Aptuit’s Pharmacokinetic/Drug Metabolism and Pharmacokinetic (PK/PD) approach, nor Aptuit’s multiple, integrated capabilities, such as medicinal chemistry, and both in vitro and in vivo services. He said, “Other than Aptuit, no one is bundling high quality, comprehensive antibacterial testing services at aggressively competitive pricing.”
An experienced team of experts
Antonio Felici, The Aptuit Center for Drug Discovery & Development’s Senior Manager, Microbiology, said, “Aptuit's unique set of assets at our Verona site means that we can provide a more in-depth understanding of antibacterial compounds that is more quickly, efficiently and economically deliverable.”
Mr. Felici explained that scientists in Verona bring a 15-year legacy of specializing in the antibacterial area. He added, “Once part of a large pharmaceutical company, we have a strong networking operation in place with public institutions and clinical centers that ensures fast access to recent and clinically relevant Gram-positive and Gram-negative pathogens. When newer, hard-to-come-by isolates/pathogens are needed for inclusion in animal models, pharmaceutical companies can call on us as a reliable resource. Aptuit can also develop animal models that are based on clinical isolates provided by clients.”
Aptuit’s knowledgeable team of scientists at The Aptuit Center for Drug Discovery & Development is familiar with the regulatory requirements associated with antibacterials and they provide foremost expertise in translational studies. The team has taken a vast number of molecules from discovery through development with low attrition and substantial success.
A significant industry need for bundled antibacterial services
While most pharmaceutical companies are active in antibacterial development, it is currently of most concern to medium and large entities. A trend, however, is emerging, extending activity to small biotechs that are being created by international institutions. These biotechs are looking for full outsourcing services, from lead identification to Phase I clinical studies. There is also an ongoing need for these services within the academic community