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.