02 April 2009 22:03 [Source: ICIS news]
NEW YORK (ICIS news)--Switzerland-based fine chemicals company Lonza has received safety certification for handling highly potent active pharmaceutical ingredients (HPAPIs) at a new plant in Visp, the company said on Thursday.
Safebridge, a safety, health and environmental consulting firm, certified the plant for the handling of HPAPIs that will be used in the manufacturing of antibody-drug conjugates (ADCs). The facility, which came on line last year, is the first such plant in continental Europe to receive the certification, according to Lonza.
An emerging drug class, ADCs are being developed primarily for the treatment of cancer. Unlike typical drug therapies, ADCs are guided to the desired site of activity by the antibody. The precise targeting means greater efficacy and consequently lower dosages, a particularly valuable feature in cancer drugs, which are typically highly toxic. According to Lonza CEO Stefan Borgas, the company is currently working on one ADC that is in Phase III trials, the last stage of clinical trials before a drug is submitted to regulatory authorities for approval. Five others are in the pipeline, he said.
According to Lonza CEO Stefan Borgas, the company is currently working on one ADC that is in Phase III trials, the last stage of clinical trials before a drug is submitted to regulatory authorities for approval. Five others are in the pipeline, he said.SafeBridge certification, which includes a 60-element review of programmes, procedures, containment and control of HPAPIs, is used for both internal assessment purposes and to assure potential customers of a company’s capabilities.
“The SafeBridge certification shows our advanced capabilities and experience in safely and effectively producing antibody drug conjugates,” said Uwe Bohlke, head of Lonza Exclusive Synthesis.
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