BELGIUM
Louvain-la-Neuve
Our Louvain-la-Neuve site offers multipurpose Highly Potent API (HPAPI) capabilities including preparative HPLC requiring containment down to OEB5, OEL up to 0.1 µg/m3/shift, for production and laboratories.
Minakem Highly Potent, was a member of the Ajinomoto Omnichem group until being acquired by the Minafin Group in 2015.
We have extensive experience of process design based on in-house R&D center, working together with our industrialization and project management team for successful scale-up and cGMP production from grams to hundred kilograms of your HPAPIs, key intermediates and controlled substances for multistep synthesis.
Our team can also offer regulatory filling support for the US, EU, Japan and China.
Key Facts
- Highly Potent Active Pharmaceutical Ingredients (HPAPI), cytotoxic / cytostatic compounds
- Controlled substances manufacturing capabilities and licence to operate
- 23.2 m3 reaction capacity
- Controlled substance manufacturing
Compliance approvals
AFMPS (EU/Belgium) / FDA / Japan
Facility Details
- Fully designed for OEL up to 0.1 µg/m³/8h (OEB5)
- Research & Development lab under containment for highly potent compounds
- R&D analytical development and QC laboratories
- Scale-up and commercial manufacturing within high containment facilities
- Filter, tray dryer, centrifuge installed in isolator for flexible and safe handling of powders for 1 to 10 kgs batches.
- Corrosion resistant Kilo lab with 10 liters reactors
- Preparative HPLC Hipersep® lines : 50 mm, 110mm and 300mm
- Freeze drying technologies
- 13 Reactors and 15 stirred vessels from 60 to 2500 liters glass lined, stainless steel or Hastelloy®,
- Centrifuge and two filter dryers (0.4m² in stainless steel and 0.8 m² in Hastelloy®)
Core capabilities
- cGMP custom synthesis from kilo-lab to multi-kg scale
- Complex Multi-step HPAPI process development, manufacturing and analytical development
- Industrialization from feasibility to commercial scale
- Hydrogenation
- Chlorination
- Cyanidation
- Lithiation
- Chiral synthesis
- Organometallic reactions
- Cryo technology (-80°C)
Dunkerque – France
Commercial production of small molecule APIs
- Large scale manufacturing
Montreal – Canada
Development and commercial production of small molecule APIs and Steroids
- Fit for purpose process and analytical development with timely and robust scale-up from clinical to commercial supply
- Dedicated steroid manufacturing unit
Louvain-la-Neuve – Belgium
Development and commercial production of small molecule Highly Potent APIs (HPAPIs) and Steroids
- Fit for purpose process and analytical development with timely and robust scale-up from clinical to commercial supply
- OEL: 0.1µg/m3/shift and Industrial Preparative HPLC
Beuvry-la-Foret – France
Development and commercial production of small molecule APIs
- Fit for purpose process and analytical development with timely and robust scale-up from clinical to commercial supply
- Home to Minakem’s R&D Center of Excellence