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Penning an Injectables Partnership

The result of several years' collaboration, Eli Lilly Laboratories and Rexam form a partnership in France for the production of a NEW insulin injection pen.

Lauren R. Hartman, Senior Editor -- Packaging Digest, 8/1/2008

Eli Lilly’s plant near Strasbourg, France will produce the glass cartridge filled with insulin and inserted into the pen.
With an estimated 246 million diabetic patients in the world, and incidence of the disease mounting constantly, a new insulin injection pen for the treatment of diabetes is about to go into production in France, to be made and marketed by the Eli Lilly and Co. Group and handled by Rexam Pharma (www.rexam.com). Rexam's La Verpillière plant in Isère, France, which specialities in drug-delivery systems such as asthma inhalers and injection devices, was inaugurated on June 18 for construction of an expansion for the pen project.

Eli Lilly and Rexam are both investing in their French manufacturing facilities in order to produce the pen. The result of several years of collaboration between Rexam Pharma and the Eli Lilly and Co. Group, the insulin injection pen partnership is expected to go onstream in 2009.

Incorporating more than a dozen plastic parts and a metal spring, the new insulin injection pen will feature two sections: one has a dose-selection mechanism and the other forms a protective cap. The two pen sections will be produced at the La Verpillière site, while Lilly's Fegersheim site in Alsace near Strasbourg will produce a glass cartridge filled with insulin that will be inserted into the pen. The new pen will be marketed worldwide.

Lilly's Fegersheim site, which specializes in injectables, is the company's biggest industrial production site in the world, with production for insulin, parathyroid hormone and growth hormones. The Fegersheim plant will also assemble the pen sections around the glass cartridge of medicine during the device's final assembly process.

The new insulin injection pen will be marketed worldwide. Two pen sections will be produced by Rexam.
To produce the pen section components, Rexam will equip it plant with dedicated Staubli (www.staubli.com) robotic systems, injection presses, marking machines and an assembly line with ultrasonic welding, sticking and packaging technology. Each phase of the process will be camera-monitored, Rexam says. About 3,800 sq m of the La Verpillière building will be devoted to manufacturing the product to meet global demand.

Designed to be produced by multiple molds on injection presses at La Verpilliere, the plastic parts will be made of materials chosen specifically by the Lilly group according to the particulars of the end use of the device.

Before the pens can be brought to marketable production, equipment validation will take place to provide diabetic patients who use the pen with what Lilly calls “perfect reproducibility of the injected doses.”

Laurence Quesdeville, Rexam's communications spokesperson in France, tells PD that Rexam is investing 7 million euros in equipment for the project at the La Verpillière plant. The facility specializes in drug-administration systems, such as inhalers for asthma and injectable devices.

Eil Lilly’s Fegersheim site, which specializes in injectables, is the company’s biggest industrial production site in the world.
“The objective is to set up and validate the industrial equipment in hopes of starting production in 2009,” Quesdeville explains.

Rexam says its facility adheres to Good Manufacturing Practices (GMP) in compliance with pharmaceutical industry requirements that apply to both the actual medicine and its container.

Lilly's most important production site at Fegersheim is transforming an existing 600 sq m and investing about 35 million euros in new production methods, the first of which will be delivered in the second half of 2008.

After Rexam's acquisition of Precise Technology USA in 2005, it established a relationship between Rexam Pharma at La Verpillière and Lilly Laboratories' production site at Fegersheim. 

Rexam says it is demonstrating the capacity to manage such a large-scale industrial project, and Lilly is bolstering its supplier portfolio for plastic parts, entrusting the production of the pen parts to Rexam.

Special project teams at both companies are making the long-term cooperation possible. The partnership is expected to create approximately 50 jobs at the La Verpillière plant in the long run, Rexam reports.


More information is available:
Rexam Pharma (U.S.), 847-541-9700. www.rexam.com.
Staubli Corp., 864/433-1980. www.staubli.com.

 

FDA Approves a Form of Nano Ink Technology to Fight Counterfeiting

The Food and Drug Administration has approved the use of brand-protection technology from NanoInk's NanoGuardian Div. (www.nanoguardian.net) on an un-named client's products, NanoGuardian announced in June. NanoGuardian says that it focuses exclusively on delivering brand-protection solutions to fight illegal diversion and counterfeiting.

Reported in a recent Drug Store News eletter, the technology, called NanoEncryption, uses nanolithographic encryption to covertly imprint information directly onto tablets, capsules and vials. NanoGuardian says the information includes dosage strength, expiration date, manufacturing information and the targeted site of distribution.

“This novel technology is virtually impossible to copy and creates an impenetrable barrier to reverse engineering by counterfeiters,” says NanoInk chief executive officer James Hussey.

The World Health Organization estimates that $55 billion worth of counterfeit and diverted pharmaceutical products enter the supply chain yearly. NanoInk estimates that pharmaceutical companies lose $180 million/yr to counterfeiting and diversion. NanoInk launched NanoGuardian in May.

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