Key Figures
- Maximum volume of 5 million units / year
- State of the art extrusion and co-extrusion equipment
- Primary and secondary packaging
- Maximum 2 shifts / day
- Grade C and D environment
- Cold storage
Overview
Mithra has a strong heritage in Polymer Technology for Long Acting Drug Developments
- Experience with multiple drug delivery strategies for drug / device combination product
- Broad range of APIs and durations (from 1 month to 5 years release)
- Applicable in multiple therapeutic fields
- Flexible processes of extrusion and co-extrusion
- Forms: Rings, Intra Uterine Systems, Implants
- Production unit grade C and grade D for hormonal use
Description
Raw materials
- Non/biodegradable (co)polymers (EVA, PDMS, PEG, PVP…)
- Broad APIs compatability (Antivirals, LHRH analogs, hormones, aromatase inhibitors etc…)
Finished products
- generic candidates
- analogue candidate of NuvaRing
- hybrid analogue candidate of Zoladex
Forms
- Biocompatible rings
- Implants / (hydro)gel
- Intra uterine systems
- Flexible durations: 1 month to 5 years
- Customizable drug concentration release
Process
- IBC mixing
- Extrusion
- Co-extrusion
- Welding
- Cutting
- Mixing
- Device assembly
- Primary packaging
- Secondary packaging
- Serialization
Capacities
- Maximum volume of 5 million units / year
- Campaign or single batch production
- Batch sizes from 10,000 to 90,000 units
- Multi-product facility
Our strenghts
- Expertise in polymer process technology
- Hormonal products
- Multi-product facility
Technical Equipment
- IBC with 300 L capacity
- IBC cleaning in place: full automated with IBC connection in washing room with connection to toxic waste
- Mixer for IBC allowing to obtain homogeneous powders mixture
- Lifting column (5 m) allowing connection between IBC and extruder feeder
- Twin screw extruder with throughput up to 15 kg/h
- Co-extruder: combined 25 mm single screw extruder and 16 mm single screw extruder
- Welding equipment using induction technology
- Primary and secondary packaging equipment
- Full containment with passive and active valves
Mithra CDMO
Rue de l’Expansion 57
4400 Flémalle
Belgium
Phone: +32 (0)4 353 37 00
Email: info@mithracdmo.com
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