Profile: Albany Molecular Research Inc (AMRI.O)
22 Apr 2014
Albany Molecular Research, Inc. (AMRI), incorporated on June 20, 1991, is a contract research and manufacturing company. The Company provides customers with fully integrated drug discovery, development and manufacturing services. The Company operates in two segments: Large Scale Manufacturing (LSM) and Discovery, Drug Development and Small Scale Manufacturing (DDS). Its LSM segment activities include pilot to commercial scale production of active pharmaceutical ingredients and intermediates, sterile syringe and vial filling and high potency and controlled substance manufacturing and its remaining activities, including drug lead discovery, optimization, drug development, and small scale commercial manufacturing represent its DDS business segment. AMRI supplies a range of services and technologies that support the discovery and development of pharmaceutical products and the manufacturing of active pharmaceutical ingredients (API) and drug product for existing and experimental new drugs. In March 2014, the Company acquired Cedarburg Pharmaceuticals Inc.
Drug Discovery Services
AMRI performs integrated drug discovery programs. The Company’s drug discovery services include assay development and design, screening, screening libraries, natural product services, medicinal chemistry , computer-aided drug discovery (CADD), in vitro admet , bioanalytical services , network of pharmacology service providers and provision of in sourced services.
The Company, in its assay development and design Services offers custom assay design and development services to clients in the pharmaceutical, biopharmaceutical and agrochemical industries who are starting from a target or who are supporting ongoing lead discovery programs. This service can be delivered independently to a client, or integrated with its range of drug discovery services. The Company’s offering of screening capabilities, coupled with access to its range of sample collections, give customers the tools to identify and optimize lead compounds. In Its screening libraries services the Company had created a series of small molecule synthetic compound libraries and a complementary collection of natural product extracts from marine, plant and microbial sources designed for screening and hit-to-lead programs. Its libraries include natural products libraries, target focused discovery libraries, commercial sample library, diverse AMRI sample library and diverse fragment based library.
The Company’s medicinal chemistry capability is integrated with its other drug discovery services, allowing for a one stop shop approach towards outsourcing lead discovery and optimization efforts. Its CADD services use computational software and techniques to help identify leads against selected therapeutic targets, as well as to support medicinal chemistry lead optimization programs. The Company conducts in vitro ADMET assays to evaluate metabolism, bioavailability, pharmacology and toxicology of compounds. The Company develops and executes bioanalytical methods for extraction and quantitation of drug and metabolites in biological fluids and tissues to support preclinical and clinical studies. This service is provided stand-alone or can be coupled directly with services provided by our network of in vivo testing providers. The Company in its network of pharmacology service provider’s service had worked in collaboration with multiple in vivo pharmacology and preclinical safety assessment providers. The Company had developed business models whereby any combination can be established in a client facility with AMRI.
The Company’s Chemical development involves the scale-up synthesis of a lead compound and intermediates. Its chemical development services include process research and development, custom synthesis, process safety assessment, scale-up capabilities, high potency and controlled substances, analytical services, preformulation services and physical characterization, preparative chromatography, IND support services, fermentation development and optimization and building blocks collection and database.
Current Good Manufacturing Practices (cGMP) API Manufacturing
The Company provides chemical synthesis and manufacturing services for its customers in accordance with cGMP regulations. Its Albany, New York location has production facilities and quarantine and restricted access storage necessary to manufacture quantities of drug substances under cGMP regulations for conducting clinical trials from Phase I through Phase II, and later stages, including commercial API, for selected products, based on volume and other parameters. Its manufacturing facility in Rensselaer, New York is equipped to provide a range of custom chemical development and manufacturing capabilities. The Company conducts commercial cGMP manufacturing of APIs and advanced intermediates. Its large-scale cGMP manufacturing facilities provide synergies with its small-scale development laboratories, offering its customers services at every scale, from bench to production.
Formulation Development and cGMP Formulation Manufacturing
The Company offer s formulation development services for solid dosage, solution, suspension, topicals and injectables, cGMP early clinical phase capsules filling using Xcelodose technology and cGMP early clinical Powder in Bottle (PIB) for solution and suspension. Its formulation services include aseptic fill and finish, aseptic lyophilization, neat API or pharmaceutical blend in capsules, PIB for solution and suspension, blending and sieving, milling, tableting, rheology, roller compaction, wet granulation, fluid bed processing, including wurster coating and all associated analytical testing for dosage formulation products.
Analytical Chemistry Services
The Company provides analytical chemistry services for drug discovery, pharmaceutical development and manufacturing. Its analytical services includes impurity identification and structure elucidation, method development, qualification and validation, preformulation and physical characterization, quality control, stability services, analytical and preparative supercritical fluid chromatography, preparative chromatography, good laboratory practices (GLP) bioanalytical services and regulatory support/quality assurance.
Albany Molecular Research Inc
21 CORPORATE CIRCLE,
P O Box 15098
ALBANY NY 12203-5154