AMRI Receives SafeBridge® Potent Compound Safety Certification
AMRI Certified for Safe Handling of Potent APIs
Albany, NY - AMRI (NASDAQ: AMRI) announced today the certification of its high potency research laboratories and GMP-manufacturing facilities in Rensselaer, New York for the safe handling of potent active pharmaceutical ingredients (APIs) by SafeBridge® Consultants, Inc. The SafeBridge Potent Compound Safety Certification applies to specific AMRI laboratories and manufacturing areas designed for the research, development and manufacture of potent compounds and certifies AMRI is competent and proficient in the safe handling of potent active pharmaceutical ingredients ("APIs").
AMRI has extensive experience in the cGMP production of highly potent compounds, from grams to hundreds of kilograms per year. AMRI's SafeBridge-certified facilities in Rensselaer include jacketed glass reactors, portable Hastelloy or glass-lined kettles, portable and fixed pressure filters/dryers, HPAPI isolators, as well as particle size reduction technology.
"Receiving SafeBridge certification demonstrates AMRI's scientific and operational expertise in working safely with highly potent compounds, as well as the company's commitment to provide customers with products and services that meet the highest standards for quality and regulatory, safety and environmental compliance," said AMRI Chairman, President and Chief Executive Officer Thomas E. D'Ambra, Ph.D.
SafeBridge conducted a 60-element review of AMRI programs, procedures and facilities used for the containment and control of potent APIs, including an on-site assessment of potent compound manufacturing and laboratory areas and equipment, training, toxicology and industrial hygiene practices. The SafeBridge Potent Compound Safety Certification program verifies performance with established criteria in management, evaluation, containment, control and communication elements of potent compound production operations.
About AMRI
Founded in 1991, Albany Molecular Research, Inc. provides scientific services, products and technologies focused on improving the quality of life. AMRI works on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world's leading healthcare companies. As an additional value added service to its customers, the company is also investing in R&D in order to expand its contract services and to identify novel early stage drug candidates with the goal to outlicense to a strategic partner. With locations in the U.S., Europe, and Asia, AMRI provides customers with a wide range of services, technologies and cost models.
SOURCE: Curia