Lonza Group confirms commitment to Visp (CH) production site
Lonza Group today confirms its commitment to its major production site in Visp in the canton Valais, Switzerland, announcing the decision to invest over CHF 100 million in a new cGMP facility for microbial manufacturing of biopharmaceuticals, thereby creating over 100 new jobs over the next 3 years.
After thorough evaluation of alternative sites it was decided that Visp is suited best for this important investment which will play a key role in Lonza’s strategic move to become the pre-eminent supplier to the life sciences industry.
To date the Business Sector Lonza Biotec concentrates mainly on the production of microbially derived intermediates and active ingredients of non proteinic nature whereby the R&D activities are located in Visp, Switzerland, with production taking place in Kourim, Czech Republic. After completion of this new installation, Lonza expects to be in an excellent position to cope with the wide range of inquiries concerning the production of microbially produced biopharmaceuticals. Furthermore Lonza Group through its Business Sectors Lonza Biotec (microbial fermentation) and Lonza Biologics (a world leader in mammalian cell culture fermentation) will then provide the full range of biopharmaceutical production capabilities to the pharmaceutical industry. Together with the offerings of the Business Sector Lonza Exclusive Synthesis (deals among other services with the chemical synthesis of peptides) for the pharmaceutical industry, Lonza’s global efforts to be the pre-eminent supplier to the life sciences industry will be further strengthened. These global efforts include the current expansion of the Lonza Biotec capacity of the Kourim facility, the investment in the Small Scale Production Plant in Visp, and the large scale build-out of Lonza Biologics mammalian cell culture production in Portsmouth, NH (US), all three facilities currently under construction. The total investment volume of all four projects amounts to CHF 550 million.
The new plant will have a multiproduct design and will consist of two independent production units with a fermenter volume of 1'500 l and 15'000 l respectively. Each fermenter will include a corresponding primary recovery and purification line. It has been conceived in a way such that product specific equipment can easily be added when deemed necessary. With the new facility Lonza will be in a position to supply materials for the different clinical phases through commercial supply in a versatile and flexible way.
The facility will be able to deal with intracellular soluble products, with such forming inclusion bodies and requiring refolding, as well as with secreted ones. Furthermore the facility will be "ex proof" and therefore able to handle organisms requiring feed of solvents for their culture. The plant design complies with FDA’s Centre for Drug Evaluation and Research (CDER) as well as FDA’s Centre for Biologics Evaluation and Research (CBER) requirements, including an elaborate environmental monitoring system. The project also includes an expansion of Quality Assurance (QA) and Quality Control (QC) services, as well as the R&D activities in Visp. The project will benefit from established competencies within Lonza Group, combining extensive purification experience and regulatory support with large scale fermentation and process development skills. Additionally, early process development at smaller scale can be undertaken in Lonza’s already established small scale pilot plant in Visp, currently undergoing a corresponding upgrade.
Mechanical completion and plant qualification are expected for fourth quarter of 2004 with commercial operations starting by the first quarter of 2005.
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Topic world biopharmaceutical manufacturing
Biopharmaceutical production plays a crucial role in the development and manufacture of biologics, which are essential for the treatment of various serious diseases. Various key technologies and processes of the modern biopharmaceutical industry are used, such as cell cultures, fermentation processes and the purification of biological substances, which are necessary for the production of vaccines, monoclonal antibodies and other biological drugs.
Topic world biopharmaceutical manufacturing
Biopharmaceutical production plays a crucial role in the development and manufacture of biologics, which are essential for the treatment of various serious diseases. Various key technologies and processes of the modern biopharmaceutical industry are used, such as cell cultures, fermentation processes and the purification of biological substances, which are necessary for the production of vaccines, monoclonal antibodies and other biological drugs.
