Louvain-la-Neuve (BE) – Containment facility

Our highly potent facility. The site is Located in the heart of Belgium, 20 km South of Brussels, in the Scientific Park bounded to the University of Louvain-la-Neuve.
Minakem High Potent (MHP) is a recognized world leader custom development and manufacturer of Highly Potent APIs (HAPI) requiring production under high containment systems down to OEB class 6, OEL < 0.1μg / m3 / shift.

Key FACTS

  • 1 R&D Center with 20 scientists & 5 PhDs
  • QC support: 17 experts
  • 80 m³ of reaction capacity

Core Capabilities

  • Contract Development and Manufacturing Organization (CDMO)
  • High-Potent Active Pharmaceutical Ingredients (HAPI), cytotoxic / cytostatic compounds
  • 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
  • Prep-HPLC technologies and capabilities
  • Cryogenic process capabilities
  • VINCA alkaloids manufacturing capacities (vincristine, vinblastine, vinorelbine, vindesine)
  • Narcotics manufacturing capabilities and licence to operate
  • Pilot plant
  • Research & Development lab under containment: OEL below 0.1µg / m³ / shift (OEB class 6)
  • 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

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

1970: Industrial development of purified medicinal plant extracts: Reserpiline, Vincamine

1972: Plant started operations

1974: Construction of the Louvain-la-Neuve site for Vinca Alkaloids production

1980: Merge with Poudreries Réunies de Belgique SA (or PRB, one of Belgium’s oldest and largest manufacturers of ammunition) to create OmniChem

1981: Setting up of Belgopia, production unit dedicated to the development and manufacture of controlled substances

1989: Acquisition by Ajinomoto Co. Inc., the company is renamed Ajinomoto OmniChem in 2004

1998: Revamping of the Louvain-la-Neuve facilities to allow handling of Highly Actives and Cytotoxic products under strict containment (OEB class 5)

2005: Upgrade of the finishing area and construction of a new high-containment R&D 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

2010: Construction of a new high-containment quality control laboratories

2015: Acquisition of the Louvain-la-Neuve site by Minafin Group

2018: Minakem opens new high containment facility for production of the highest class of HPAPI (OEB class 6) below 0.1µg/m³/8h

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