Belgium Europe
CHEMICAL-SYNTHETIC SERVICES in Europe
Trasis is committed to the development of cutting-edge solutions that help improve the diagnosis and treatment of major diseases among which cancers,...
About the plant
End-to-end CDMO Services
Trasis offers comprehensive services, from the chemical synthesis of small molecules and peptides to the production of ready-to-use drug solutions:
Early process development study & scaling up
- Scalable API & precursor synthesis (from R&D to commercial production)
- Raw material sourcing & cGMP assessment
- Polymorph screening, impurity profiling & stability studies
- Process analytics & regulatory (CMC) support
Industrialisation & Validation
- Analytical standards
- Analytical method development & validation
- Chiral separations & compound purification
- IND & DMF documentation support & submission
- EU QP release support
Intermediate & API Manufacturing
- Preclinical batch production & clinical trial supply
- Industrial-scale API, precursor & intermediate production
- Tech transfer & scale-up for commercialization
- GMP & non-GMP production facilites
Formulation & Sterile Fill & Finish
- Aseptic processing & customized formulations
- Small molecules, peptides, macrocycles, chelators, (in)organic salts
- Cold kits
- Kits for bioconjugation
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
Activity
- CHEMICAL-SYNTHETIC, SERVICES, Intermediates, API (Active Pharmaceutical Ingredients), Excipients, Radiopharmaceuticals manufacturing
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)
- DEA: N/A
- BSL: 1, 2, 3, 4
- Therapeutic areas: (C) Cardiovascular system, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (V09-10) Radiopharmaceuticals
- Markets: FDA (USA), EMA (EU), TGA (Australia)
Batch Size / Reactor
- Small, Medium, Large, 1 - 10 L, 10-100 L, 100 - 1,000 L
Services
- Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Tech transfer, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, CMC regulatory support, Salt screening, Fill and finish, Safety studies, Customized block synthesis, Impurity synthesis
