Collaborating on manufacturing since 2016, Cenexi and Crossject are entering a new phase of their partnership. While the production phase of the first clinical batches of the ZENEO® needle-free auto-injector is nearing completion at Cenexi’s Braine-l’Alleud site (Belgium), the next phase of the project, of a larger scale, is being implemented.
Indeed, a high capacity industrial production is now at the heart of the collaboration, with the shared responsibility to progressively scale up.
Cenexi, a reference industrial partner for Crossject
Cenexi, a French Contract Development and Manufacturing Organisation, has been supporting Crossject for the development, filling and final assembly of the ZENEO® needle-free auto-injector at its Belgian site of Braine-l’Alleud.
Their partnership, which concretely started in 2016, is based on the quality and reliability of Cenexi’s facilities, thoroughly demonstrated over the past two years, with the production of technical and then clinical batches.
The development phases, although complex, were particularly important as they allowed the creation of novel industrial filling processes (Cenexi patent filed), with customized equipment.
Cenexi will fill ZENEO® and will be able to handle the 8 molecules (Midazolam, Adrenaline, Naloxone, Terbutaline, Hydrocortisone, Methotrexate, Sumatriptan and Apomorphine) mainly dedicated to emergency situations.
With this announcement, Cenexi strengthens its positioning on innovation and sterile manufacturing expertise thanks to its human-scale agility, and its recognized skills in pharmaceutical development (with authorizations for many countries in Europe, North America, Asia, etc.).
“We have learnt to work together for several years, both in development and in manufacturing. I am very pleased to strengthen this long-standing partnership with the signing of this new agreement which will allow us to synchronize our activities to ensure the industrial production and large-scale commercialization of this highly innovative product.”
Christophe Durand, President of Cenexi
Crossject’s historic choice for industrial partnerships to accelerate the market launch of ZENEO®
The extraordinary adventure of the ZENEO® needle-free auto-injector, initiated in 2001 and crowned by more than 400 patents and multiple awards, enters a new phase in 2021, where the ramp-up of mass production is now on the agenda for its industrial supply chain.
A key success factor has been the strategic decision to divide production between in-house operations and those carried out by industrial partners, both upstream and downstream of the critical phases directly managed by Crossject.
In particular, the downstream phase, including the final assembly of ZENEO® injectors, their filling with one of the active ingredients and their packaging, has been entrusted to Cenexi.
Patrick Alexandre, CEO and founder of Crossject, explains this choice by “Cenexi’s unquestionable know-how in aseptic filling, which has been certified and demonstrated many times“.
Today, Crossject renews its confidence in Cenexi to begin the industrial ramp-up phase, i.e. the gradual implementation of the production capacities necessary for the commercial exploitation of the ZENEO® innovation over the next few years.
“Cenexi’s constant commitment and expertise, as demonstrated by the construction from scratch of two production lines dedicated to the production of our clinical batches, amply justifies the continuation of this joint-venture. I am confident that our partnership will be solid enough to successfully meet the next milestones of our commercial launch.”
ABOUT CENEXI
Cenexi, a French player in pharmaceutical manufacturing (CDMO) in Europe with 1,500 employees and €200 million in sales, has grown steadily with four production sites (Fontenaysous-Bois, Osny and Hérouville-Saint-Clair in France, Braine-l’Alleud in Belgium) and a development and industrial transfer center.
Created in 2004, the Cenexi Group is positioned on the very active international market of drugs with major therapeutic indications, relying on its spirit of innovation and its extensive expertise in manufacturing and product development.
The orientations of the new management team of the group are providing a new dynamic to the company, in particular by reinforcing its sterile manufacturing expertise which already represents 65% of its activity.
Cenexi has the capacity to produce a wide range of galenic forms with a strong expertise in cytotoxic products (including hormones).
ABOUT CROSSJECT
Crossject is developing and is soon to market a portfolio of drugs dedicated to emergency situations, including epileptic seizures, migraines, anaphylactic shock, opioid overdose, severe asthma crisis…
Thanks to its patented needle-free self-injection system, Crossject aims to become the world leader in self-administered emergency drugs. The company has been listed on the Euronext Growth market in Paris since 2014, and has received funding from Bpifrance, the French Defense Department, and the Bourgogne-Franche-Comté region.
