Key FACTS
- 1 R&D Center with 20 scientists & 5 PhDs
- QC support: 17 experts
- 80 m³ of reaction capacity
KEY API PRODUCTS
- Vincas: Vinorelbine, Vincristine, Vinblastine, Vindesine
- Remifentanil
- Fulvestrant
Core Capabilities
- Contract Development and Manufacturing Organization (CDMO)
- High-Potent Active Pharmaceutical Ingredients (HAPI), cytotoxic / cytostatic compounds
- GMP Prep-HPLC (50, 110 & 300)
- Controlled substances
- cGMP facilities (FDA, EMEA, PMDA, AFMPS)
- Multi-step API process development, manufacturing and analytical development
- Development and synthesis capacities in Quality by Design (QbD) environment
- Manufacturing and pilot process in high containment environment down to OEL 0.1µg / m³ / shift (OEB class 5)
- Freeze-drying technologies and capacities
- Cryogenic process capabilities
- Narcotics manufacturing capabilities and licence to operate
- Pilot plant
- Research & Development lab under containment: OEL below 0.1µg / m³ / shift (OEB class 5)
- Analytical development lab
- Industrialization from feasibility to commercial scale
- Hydrogenation
Compliance Approvals
- FDA (USA) – 2015
- PMDA (Japan) – 2016
- AFMPS (Belgium) – 2017
- DMF filing experience: USA, Europe, Japan,
Facility Legacy
Founded in 1972, Minakem Louvain-la-Neuve, formerly Minakem High Potent, was a member of the Ajinomoto Omnichem group until being acquired by the Minafin Group in 2015. Minakem Louvain-la-Neuve has built a 40+ years track record of success in supplying pharmaceutical and biotech companies with clinical and commercial scale cGMP APIs manufactured using world-class cost-effective production processes. Through expertise and capabilities in HPAPI, controlled substances and anaesthetic products, Minakem LLN assesses and customizes their manufacturing approach to achieve the most effective manufacturing process for their customers.
History
New cGMP kilo-lab
2023: New lyophylisator operational for the Vincas since January, new workshop for the vincas expected in April & new kilo-lab to welcome new high potent projects
2022: Commissioning of the new HPLC of 300 mm dedicated to APIs and collaboration set-up with Reach Separation
2018: Minakem opens new high containment facility for production of the highest class of HPAPI (OEB class 6) below 0.1µg/m³/8h
2015: Acquisition of the Louvain-la-Neuve site by Minafin Group
2010: Construction of a new high-containment quality control laboratories
2007: Expansion of Louvain-la-Neuve high containment site with the commissioning of a Class 5 handling facility and installation of a new microbiologic quality control laboratory
2005: Upgrade of the finishing area and construction of a new high-containment R&D laboratories
1998: Revamping of the Louvain-la-Neuve facilities to allow handling of Highly Actives and Cytotoxic products under strict containment (OEB class 5)
1989: Acquisition by Ajinomoto Co. Inc., the company is renamed Ajinomoto OmniChem in 2004
1981: Setting up of Belgopia, production unit dedicated to the development and manufacture of controlled substances
1980: Merge with Poudreries Réunies de Belgique SA (or PRB, one of Belgium’s oldest and largest manufacturers of ammunition) to create OmniChem
1974: Construction of the Louvain-la-Neuve site for Vinca Alkaloids production
1972: Plant started operations
1970: Industrial development of purified medicinal plant extracts: Reserpiline, Vincamine
1946: Omnium Chimique founded in the city of Genappe (Belgium, 20 km away from the current site) for implementing the first industrial Quinine extraction and Helicidine production