Our development activities

Early formulation - Formulation

Early formulation

Delpharm Development and his trusted partners support you during the early formulation phase thanks to its expertise in:

• API solubility.
• Hygroscopicity.
• Polymorphism.
• Solid state characterization.
• API Particle Size Distribution (PSD).
• Micronization.
• Excipient compatibility testing.

Formulation

For your formulation project of oral solid dosage forms or semi-solid dosage forms, we assist you in:

• Co-defining a Target Product Profile (TPP).
• Excipients screening.
• Binary & Complex Compatibility studies.
• Bioavailability enhancement (amorphous solid dispersions…).
• Taste masking.
• Pediatric formulation.

Oral solid dosage forms

Oral solid dosage forms

Oral solid dosage forms pilot is located in Reims, France (Paris CdG Airport 45min. & Reims - Paris 45min. by train) and is GMP certified.

Development of dosage forms :

• Tablet.
• Mini tablet.
• Coated tablet.
• Modified release.
• Orodispersible.
• Capsule.
• Beads.
• Bi layer.

Process & Equipment :

• Direct Compression.
• Roller Compaction.
• Wet granulation (HSM/FBD).
• Wurster (Bottom spray).
• Hot Melt Extrusion (HME).
• ATEX equipment.

Liquid & Semi-Solid Dosage Forms

Liquid & Semi-Solid Dosage Forms

Liquid & semi-solid dosage forms pilot, located in Orleans, France (Paris Orly Airport 80min. & Orleans – Paris 60 min. by train) and is GMP certified.

Development of dosage forms :

• Solution.
• Suspension.
• Syrup.
• Spray.
• Gel.
• Cream.
• Ointment.
• Softgel (filling solution).

Process & Equipment:

• Mixing equipment with heating/vacuum (0.1 to 150L).
• Storage Tank.
• Tube/bottle/Can filler (2 to 400mL).
• ATEX equipment.

Freeze-Drying Dosage Forms

Freeze-Drying Dosage Forms

Freeze-drying dosage forms pilot is located in St-Remy, France (Paris Orly Airport 60min.)

Activities:

• Freeze-drying cycle optimization.
• Run pilot batches.
• Industrial capacity (204 m²).

Process & equipment:

• Freeze-dryers (1,2m²).
• MiniLyos from -50°C to +50°C.
• Differential Scanning Calorimeter.
• Freeze-drying Microscopy.
• Sophisticated PAT.

Injectable dosage forms

Injectable dosage forms development center is located in Leiden, the Netherlands (Schiphol Amsterdam drive airport 30 minutes)

Development of dosage forms:

• Liquid Injections including high viscous solutions (vials and prefilled syringes).
• Lyophilized injections including suitable diluent.
• Ophthalmic formulations (liquids and gels).
• Sub-micron/micron suspension parenteral formulations.
• Liposomal injections (Lyophilized and liquid).
• Microspheres including suitable diluent.

Process & Equipment:

• Mixing (Low to high shear) with multiple sized vessels to handle formulations with broad range of viscosity.
• High pressure Homogenization for sizing (multiple options to match the customer need).
• Freeze drying/lyophilisation (Multiple options including SMART Lyophilizer assisted development).
• High energy ball milling for sizing (sub-micron sizing).
• High shear for sizing (micron sizing/deaggregation/polymer dispersion).
• Static mixing.
• Spray drying.
• Tangential Flow Filtration (TFF).
• Aseptic processing.
• Head space oxygen + Dissolved oxygen analysing to develop controlled process.

Analytical development - Stability studies

Analytical development

To assist you in your analytical development, Delpharm propose you:

• Method Development and Validation.
• Experimental test design assisted by fusion software (DoE).
• Apparent, intrinsic & flow-through dissolution.
• Automatic dissolution test for extended release.
• 60+ HPLC, UPLC, AAS & GC.
• CAD, DAD, MS & UV detectors.
• Packaging selection (predictive stability).
• Particles size analysers (Zetasizer/Mastersizer).
• Nano drop micro volume and UV-VIS spectrometer.
• DSC.
• MultiTest 2.5-i Motorised Force Testing System.
• SEM and optical microscope camera system.

Stability studies

Delpharm offers full in-house tests capability:

• All ICH & tailored conditions (large capacity).
• Accelerated.
• In use.
• Transport simulation.
• Photo stability.
• Microbiology in house.

Process development - QbD

Process development

QbD

Thanks to our expertise & practice we can offer a full or partial Quality by Design approach (ICH Q8, 9 & 10).

To what? Formulation, process development or analytical activities.

How? Using knowledge management, implementing DoE, doing risk & robustness analyses & performing tests.

Why? To reinforce the knowledge of your product, to ensure quality robustness, safety and efficacy of the product.

Batches sizes - Clinical Batches Manufacturing

Clinical Batches Manufacturing

We support you with a large range of services in terms of clinical batch manufacturing:

• GMP batches manufacturing.
• Phase 1 to Phase 3.
• Batch sizes 0.3kg to 1 Ton for oral solid dosage forms.
• Batch sizes 0.1L to 10 000L for liquid & semi-solid dosage forms.
• Bulk, bottle & blister.
• Tube, bottle & canfiller.
• Over-encapsulation.
• Matching placebo.
• EU, FDA, PMDA…

Batch sizes

Our versatility allows us to support your project throughout the different clinical phases :

Project management

Project management

• Direct & fluid communication.
• A dedicated project leader.
• Use of collaborative platform to share documentation & real time information.
• Centralized data storage with 24/24 access.
• Structured project management organization (kick-off, project meetings, escalation process & wrap up meeting).