• Our development activities

RECOGNIZE EXPERTISE

 
Constantly looking for innovative solutions, Delpharm Development has 3 pilot facilities structured by dosage forms and more than 60 experts dedicated to your success.

Our knowledge of industrial constraints taken into account all along development activities, enables us to manufacture your products under optimized conditions and thus contributes to their success.

Whatever the forms, Delpharm Development supports you from early formulation phase to scaling-up for registration batches manufacturing as well as regulatory support.

We behave as partner & put at your disposal very skilled project manager & a collaborative platform.

Thematics

Early formulation - Formulation

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

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

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

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.
Analytical development - Stability studies

Analytical development - Stability studies

Analytical development

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

  • Development and methods validation.
  • Experimental test design assisted by fusion software (DoE).
  • Apparent, intrinsic & flow-through dissolution.
  • Automatic dissolution test for extended release.
  • 50+ HPLC, UPLC, AAS & GC.
  • CAD, DAD, MS & UV detectors.
  • Packaging selection (predictive stability).

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

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

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

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).