LSMW Inhaleable Insulin Manufacturing Facility, Germany

Early in November 1998, Hoechst Marion Roussel (now Aventis) and Pfizer announced their intention to join forces in developing, producing and selling inhaleable insulin on a global scale.

The joint venture called in the merged Life Sciences Meissner + Wurst (LSMW), whose pharma-production experience was indispensable in planning the largest insulin manufacturing facility ever.LSMW GmbH Total Life Science Solutions was renamed M+W Process Industries GmbH on 1 January 2010.

The new insulin project named Diabel is located in Frankfurt, in the Rhineland Palatinate, western Germany. It was completed within 28 months. In 2006 Pfizer took over the production location.

On 8 June 2009, the plant was purchased by Sanofi-Aventis for €30m. Sanofi-Aventis exercised its intervention right in relation to a purchase contract signed between Pfizer and Mannkind in March 2009. The acquisition includes building, equipment machinery and some existing contracts.

Inhaleable insulin offers an entirely new approach to the treatment of type one and type two diabetes by improving therapy. Diabetes is a widespread chronic disease which is caused by the pancreas producing no insulin or only quantities insufficient for normal decomposition of sugar in the human body.

The plant offered the chance for inhaleable insulin to be produced for the first time ever. This was set to be a milestone in the treatment of diabetics because it would free patients from the need for injections.

Through Pfizer's collaboration with Inhale Therapeutics Systems of San Carlos, California, Pfizer acquired valuable experience in the development of the inhaler and formulation technology for pulmonary delivery of dry powder insulin. Hoechst Marion Roussel's major products were therapies for allergic, metabolic and central nervous system disorders and cardiovascular and infectious diseases.

Diabel project make-up

LSMW, a 50:50 joint venture between the Jenoptik subsidiary M+W Zander and the US based Day and Zimmermann, was commissioned to plan the insulin plant. Work was started in 1998 and completed in 1999.

As well as its engineering skills and its knowledge of pharma-production processes, the company has benefited from M+W Zander's experience in the construction of high-tech factories. M+W Zander, which was founded in 1995, plans, builds and validates pharmaceutical and biotechnology plants. The project was a major investment by HMR and Pfizer with 200 new jobs created.

The project was approved by the Darmstadt regional council before work could begin on the plant. Once the construction process was completed in 1999, the production plant was inspected and approved by the international drug regulatory agencies before commissioning and commercial production could begin.

By October 2000, buildings for the utilities, administration and laboratories were mechanically complete. The fermentation area, reprocessing and cleaning area were completed by November and December 2000. By spring 2001, the operational qualification of the facility was achieved.

Frankfurt plant details

The plant provides space for fermentation, reprocessing, cleaning and treatment of final product, apart from supply and disposal. The fermentation, reprocessing and high-level cleaning facilities are located in different buildings.

The main building comprises offices, central laboratories, measuring station, archives, changing rooms and recreation rooms. The supply and disposal facility is equipped with a buffer media annexe and raw materials warehouse. For liquid raw material and wastewater treatment, another raw material warehouse is constructed at the exterior.

The plant uses a genetically changed strain of E.coli to produce bio-synthetic human insulin.