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12/06/2007
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| Lonza receives approval for new LAL manufacturing suite |
Lonza further expands its capacity in the endotoxin detection area by upgrading its manufacturing suite for LAL (Limulus Amoebocyte Lysate) in Walkersville, MD, USA. The site has received approval from the U.S. FDA (Food and Drug Administration) to manufacture kinetic chromogenic lysate1 in the new LAL manufacturing suite. This multi-million USD expansion program included investments in a new high capacity lyophilizer2, new sterile manufacturing facilities, improvements to filling line efficiencies, as well as improvements to infrastructure and supporting systems, ensuring that the Walkersville facility remains at the forefront of regulatory compliance. Other lysate formats will be validated for manufacture in the new manufacturing suite in the near future.
The opening of the new facility now gives Lonza two independent lysate manufacturing suites, allowing continuous manufacturing even when one suite is undergoing maintenance. The new facilities will improve manufacturing consistency, provide larger lot sizes for high volume customers and will ensure ready availability of lysate supply, in line with projected growth plans, for the next 10-15 years.
Lonza’s endotoxin detection business has seen sustained growth over a long period and investing in the new manufacturing facility is a vital step in ensuring that Lonza continues to meet its customers demands now and in future.
Explanations
- Kinetic chromogenic lysate: A quantitative test method for the detection of endotoxin in pharmaceutical products and medical devices. The kinetic chromogenic test is particularly suited to the testing of complex products or biopharmaceuticals and is Lonza’s largest selling test method.
- Lyophiliser: Also known as a freeze-dryer. This unit freeze-dries the lysate to produce a dry powered ‘cake’ that has the necessary long term stability for storage. Lyophilised lysate can be stored at 2-8 degrees for up to three years.
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 SWX Swiss Exchange. In 2006, Lonza had sales of CHF 2.91 billion. Further information can be found at www.lonza.com.
For further information:
Head Corporate Communications
Janet White
Tel +41 61 316 8566
Fax +41 61 316 9566
janet.white@lonza.com
Media Relations
Dominik Werner
Tel +41 61 316 8798
Fax +41 61 316 9798
dominik.werner@lonza.com
Investor Relations
Alexandre Pasini
Tel +41 61 316 8835
Fax +41 61 316 9835
alexandre.pasini@lonza.com
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