January 22, 2009
SAFEBRIDGE CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced that LONZA AG, Visp, Switzerland (“Lonza”) has met the criteria established under the SafeBridge program for “Potent Compound Safety Certification” and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients. The SafeBridge® Potent Compound Safety Certification applies to the Lonza antibody drug conjugate (ADC) manufacturing and process development facilities, operations and associated quality control laboratories.
SafeBridge conducted a 60-element review of programs, procedures, containment and control of the active pharmaceutical ingredients at each ADC workplace. Based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that Lonza has met current industry standards in the safe handling of ADCs.
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. Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology and industrial hygiene.
Since program inception in 1999, six organizations have achieved “Potent Compound Safety Certification”. LONZA AG is the first continental European contract manufacturing organization to achieve “Potent Compound Safety Certification”.
SAFEBRIDGE CONSULTANTS, INC. is the premier occupational health and safety consulting firm to the pharmaceutical, biotechnology and fine chemical industry 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 400 business units worldwide and is a leader in recognizing, evaluating and controlling exposures to potent active pharmaceutical ingredients and products.
For more information, contact:
John P. Farris, CIH
President and Chief Executive Officer
650-961-4820 x 229