Basel, 02 April 2009 – Lonza’s facility for antibody drug conjugates (ADC) in Visp, Switzerland, was recently certified by SafeBridge® Consultants as competent and proficient in the safe handling of highly potent active pharmaceutical ingredients (HPAPIs). The new state-of-the-art plant, which came on stream in 2008, is the first in continental Europe to meet the criteria established under the SafeBridge® program for “Potent Compound Safety Certification.”
“The SafeBridge® certification shows our advanced capabilities and experience in safely and effectively producing antibody drug conjugates”, said Uwe H. Böhlke, Head of Lonza Exclusive Synthesis. “As a leader in both antibody production and advanced chemical synthesis, we are uniquely positioned to deliver the highest level of quality in this challenging new field of pharmaceuticals.”
Lonza’s experience with antibody drug conjugates goes back to early 2006. Today, the custom manufacturer has the expertise, procedures and equipment to produce conjugates in milligram to multiple kilogram quantities per batch for both clinical and commercial supply. Additionally, Lonza offers a complete set of process development, analytical, optimization and regulatory support services.
To certify the plant, 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® has deemed that Lonza meets current industry standards in the safe handling of ADCs. The SafeBridge® Potent Compound Safety Certification applies to Lonza’s ADC manufacturing and process development facilities, operations and dedicated quality control laboratories.
About Lonza
Lonza is one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2008, Lonza had sales of CHF 2.937 billion. Further information can be found at www.lonza.com.
About SafeBridge® Consultants
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.
Further information can be found at www.safebridge.com.
