Cenexi Laboratoires Thissen

Cenexi Laboratoires Thissen

This 8,000 m2 plant, with buildings dotted around a site of nearly seven hectares, is located 20 km south of Brussels and has 340 employees*. It specializes in the production of sterile highly potent injectables, mainly against cancer.

About the plant

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 110 Cenexi Services experts*, the 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.

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• MHRA (UK GMP)

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Activity

• Injectables, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• DEA: Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL: 1, 2, 3, 4
• Therapeutic areas: (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support

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