April 22, 2020
SafeBridge® Consultants, Inc. (“SafeBridge”), headquartered in Mountain View, CA, announces today that the Albany Molecular Research, Inc. (AMRI) manufacturing facility in Rensselaer, NY, has been re-certified under SafeBridge’s Potent Compound Safety Certification program. The facility not only meets the criteria established for competency and proficiency in the safe handling of highly potent active pharmaceutical ingredients (APIs) but is the first company to achieve “Industry Leader” status, which represents AMRI as the first in its industry category to achieve certification. The SafeBridge Potent Compound Safety Certification of AMRI applies only to specific laboratory and manufacturing areas involved in the manufacture of APIs and synthetic intermediates.
The Rensselaer facility, part of AMRI’s network of high potency Centers of Excellence, supports scale-up from development stage to large-scale commercial manufacturing of highly potent compounds.
SafeBridge conducted a 60-element review of health and safety programs, procedures, exposure controls, and process containment of synthetic chemistry operations with occupationally potent APIs at the company’s site. Based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that AMRI meets the standards identified to be an Industry Leader for the safe handling of potent APIs in the identified areas.
“I am so proud of our team at Rensselaer for being the first in the industry to earn leader status from SafeBridge for our high potency capabilities,” said John Ratliff, CEO of AMRI. “This accomplishment underscores AMRI’s commitment to excellence and advancing the benchmark for potent compound manufacturing across our industry.”
The SafeBridge Potent Compound Safety Certification program evaluates performance with established criteria in management, compound evaluation, exposure control, and communication elements of potent pharmaceutical compound production operations. Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology, and industrial hygiene.
AMRI, a contract research development and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in discovery, development, analytical services, and API and drug product manufacturing.
SAFEBRIDGE CONSULTANTS, INC., a subsidiary of Trinity Consultants, Inc. is the premier occupational health and safety consulting firm to the pharmaceutical, biotechnology, and fine chemical industries with offices in Mountain View, CA, New York, NY and Liverpool, UK. SafeBridge has provided the Potent Compound Safety Triangle® of services in industrial hygiene, occupational toxicology, and industrial hygiene analytical chemistry to over 1,000 business units worldwide and is a leader in recognizing, evaluating, and controlling exposures to potent APIs and products.