Boehringer Ingelheim takes on prefilled syringes

The announcement was made this week following approval in October by the US Food and Drug Administration (FDA) for the German company to manufacture an undisclosed biological drug in prefilled syringes for an undisclosed US-based company.

The European Medicines Agency (EMEA) granted approval in July.

Boehringer Ingelheim has been the contract manufacturer for the drug, obtained from mammalian cell culture fermentation at the company's biotech plant, since 1998.

The drug had previously been formulated as a lyophilised (freeze dried) product that was reconstituted with a solvent in a vial plus syringe.

The move to prefilled syringes underpins Boehringer Ingelheim's move to follow industry trends while also expanding the company's product portfolio in contract manufacturing.

"This additional service by Boehringer Ingelheim expands our 'one-stop-shop' service from cell line development up to marketing of biopharmaceutical drugs, and the prefilled syringe market is a growing market," Boehringer Ingelheim spokeswoman Heidrun Thoma told in-PharmaTechnologist.com.

A recent study by IMS Health and Becton Dickinson predicted growth in the prefilled syringe market to be more than 12 per cent per year.

In 2006, 1.4 billion prefilled syringe units were sold with the expectation this figure will grow to 2.4 billion units in 2010.

"Compared to drug administration by means of vials and syringes, prefilled syringes have several advantages, above all the convenience and safety for patients or nurses.

Furthermore, the risk of administering the wrong drug or giving the wrong dose is significantly reduced," Thoma said.

Back in 2005/2006, the company expanded its Biberach, Germany, facilities by approximately 320 square metres, applying a 'house-in-house' principle in an existing facility.

The cost of the investment was not disclosed.

The company now has a new filling and packaging line that has the capacity of 25 million syringes per year.

Commercial production on the new line started in the second quarter of this year.