Braine-l'Alleud

This 8,000 m² plant, with buildings dotted around a site of nearly seven hectares, is located 34 km south of Brussels and has 350 employees. It specializes in the production of sterile highly potent injectables, mainly against cancer.

 

Cenexi acquired this site (Formerly laboratoires Thissen) in 2012. The plant is a major manufacturer of sterile highly potent compounds and offers various sterile dosage forms for oncological purposes.

 

The site thus manufactures sterile, liquid, and freeze-dried vials as well as pre-filled syringes for customers with varied profiles: Big Pharmas, startups, young innovative biotechs or generics, from all over the world.

 

The site is also home to 40 of the 120 Cenexi Services experts, the independent entity supporting formulation activities, analytical and pharmaceutical form developments, industrial transfer, and regulatory support for experimental products or products already on the market to be manufactured on Cenexi sites.

 

As such, Cenexi Braine-l’Alleud has a sterile products development unit with three components: analytical development, pharmaceutical development, and two pilot production units (Clean rooms GMP accredited by the authorities), for the manufacture of early development phase batches and clinical batches. This unit specializes in high potent products (cytotoxics), biological products (monoclonal antibodies, proteins, antibody-drug conjugation, viruses), and narcotic substances.

 

The site accommodates the entire drug manufacturing process, from formulation to pilot-scale production and transfer to production units.

Key figures

sterile oncology products manufactured onsite to treat 13 types of cancer (mainly lymphoma, leukemia, kidney, brain, and pancreatic cancers)

products under development for five indications, including three new ones to treat lung, prostate, and gallbladder cancers

sterile product development center onsite

Pharmaceutical forms

  • Solutions in vials
  • Freeze-dried vials
  • Pre-filled syringes

Most recent investments

  • A new state of the art aseptic complex of over 1,000 m² devoted to the manufacture of sterile pre-filled syringes, including a high potent product formulation area, an equipment preparation and autoclaving room, and a new syringe line: based on aseptic nest filling of sterile syringes (PFS) and equipped with fully automated In Process Control (IPC), this 5 heads filling machine can produce 15 million 1-ml syringes per year.
  • A new freeze dryer: this 25-ton piece of equipment was assembled in a new purpose-built 300 m² building and installed in a 45 m² extension (grade A/B) adjoining the current aseptic area. It is used to manufacture high potent products for various customers around the world. With its 30 m² of shelves, this new freeze-dryer significantly increases the site’s freeze-drying capacity.

Partnership with Crossject

As part of a partnership dating back to 2016, the Braine site also supports Crossject, a start-up developing self-administered emergency drugs and medical devices with a view to their marketing, in the development, the filling with one of the eight drugs, and the final assembly and packaging of the ZENEO® auto-injector, a very innovative needle-free drug injection system for which over 400 patents have been filed. Crossject wished to work with Cenexi due to its recognized expertise in designing sterile processes.

The development phases, although complex, were particularly important because they allowed Cenexi to create new industrial filling processes (Cenexi patent pending) with made-to-measure equipment. A new milestone was reached at the end of 2021 with the validation of the ZENEO® Midazolam 10 mg clinical batch (intended for epileptic seizures). Cenexi teams at Braine-l’Alleud were able to launch the validation batches, a step prior to the Marketing Authorization Application (MAA). A second milestone was reached in March 2022 with the announcement of the conformity of the first industrial transposition batch (necessary prior to starting the validation program) of ZENEO® Hydrocortisone (acute adrenal insufficiency). Once again, following this production, Cenexi teams launched the validation batches, a step prior to the Marketing Authorization Application (MAA) scheduled for 2023.

> Learn more about the partnership with Crossject.

Discover the site in video