Gerresheimer, an innovative system and solution provider and global partner to the pharma and biotech industries, recently produced at its Pfreimd location in Germany the 100 millionth sub-assembly for the current applicator for the Nexplanon contraceptive implant, a hormonal contraceptive from Organon.
Ever since the first clinical samples were manufactured for the market authorisation of Nexplanon in 2006, the pharma company has been working with Gerresheimer to produce the accompanying applicator. Developed by Gerresheimer and Organon, this applicator has been produced in series since 2008.
Since the start of production, Gerresheimer has manufactured 100 million applicators on ultra-modern, automated production systems in Pfreimd. This collaboration with Organon is an example of how Gerresheimer supports pharma companies with containment solutions and drug delivery systems throughout the entire product life cycle – from the development of clinical samples to industrial production and continuous optimisation.
The first birth control pill was sold in Germany on 1 June 1961. Besides the pill, there are now other hormonal contraceptive methods such as the contraceptive patch, the vaginal ring, the contraceptive injection, copper IUDs, and contraceptive implants. Globally active pharma company Organon was one of the first to produce the birth control pill.
Organon’s vision is ‘a better and healthier every day for every woman’. The range of hormonal contraceptives developed by Organon includes the Nexplanon contraceptive implant. The implant is inserted under the skin of the inner upper arm using an accompanying applicator. The active agent etonogestrel, a progesterone, is released steadily over a period of three years.
Clinical samples for market authorisation
Gerresheimer has been working very closely with Organon since 2005, when the first clinical samples of Nexplanon were developed along with the accompanying applicator for market authorisation. At Gerresheimer in Pfreimd, Germany, where medical systems have been produced using plastic for over 50 years, 100 million of these applicators were manufactured on four in-house assembly systems and delivered from market authorisation until today.
Entire applicator production chain in Pfreimd
Seven of the nine necessary applicator components are produced by Gerresheimer in Pfreimd, while two components are supplied parts. Gerresheimer in Pfreimd takes care of the entire production chain of the applicator, from injection moulding to assembly, inspection, all the way to packaging for Organon.