Services / Drug Product Development and Manufacturing

We know complex Drug products

Complex formulation. We know it. Our drug product team covers the full development journey – formulation, analytical development, manufacturing, and stability – for the molecules that push the limits of conventional dosage forms. From first milligram to GMP batch.

Driven by science. Diligent.

De-pressuring your clinical journey

Our drug product services are powered by a team of experts in analytical sciences, formulation development, manufacturing, and scientific reporting. Our integrated capabilities are specifically designed to support all phases of development and guide you through to market approval.

Our state-of-the-art drug product development facilities are equipped with specialized analytical and formulation laboratories, alongside GMP-accredited manufacturing suites, outfitted to ensure your drug products meet the highest quality standards. Additionally, our cutting-edge warehousing facilities and dedicated packaging and labeling areas are available to streamline the entire process.

By combining comprehensive formulation characterization and advanced analytical services, we provide the most detailed data available to de-risk your path to the clinic and to the market.

01 Formulation

Drug Product Formulation Development

We guide our customers into making smarter formulation choices. This reduces the risk of clinical failure and ensures your product reaches the clinic rapidly via the most efficient route. We have the capabilities to develop formulations for a broad range of administration routes, from oral and topical to intranasal, ocular and parenteral, and can handle highly potent compounds and controlled substances.

A Oral Dosage Forms

  • API in capsule/vials
  • Powder blend in capsules
  • Liquid in capsules
  • Immediate or modified release tablets/capsules
  • Mini tablets
  • Orally disintegrating tablets
  • Solutions and suspensions
  • Sachets
  • Pediatric oral dosage forms

Bioavailability Technologies

  • Nanosuspensions
  • Spray dried amorphous solid dispersions
  • Hot Melt Extrusion amorphous solid dispersions
  • Lipid-based formulations

B Injectable Dosage Forms

  • Sterile drug products – aseptically prepared
  • Liquid formulations in vials
  • Small molecules (including peptides)
  • Nanomedicines
  • Biotechnology products (e.g. recombinant proteins, monoclonal antibodies)

C Topical & Nasal Forms

  • Topical (solutions, creams, ointments)
  • Nasal (sprays, inhalants)
02 Analytical

Drug Product Analytical Development

We operate full-fledged, state-of-the-art analytical labs with a wide variety of capabilities to support drug development, removing the need for additional partners and simplifying your supply chain. Ensuring a complete understanding of critical material attributes, product quality attributes, and stability is key to the success of your drug development process. We provide flexible, agile, and timely analytical support tailored to your formulation needs.

Chromatographic Methods

State-of-the-art chromatography capabilities for comprehensive product analysis.

  • HPLC/UPLC/GC method development and optimization
  • Identification of degradant products and impurities (LC/MS)
  • Analytical method validation and method transfer activities
  • Drug product specification setting
  • Quality control and release testing

Dissolution Methods

Dissolution is a key quality attribute for solid dosage forms. We offer method development support using USP-1, USP-2, and USP-4 equipment.

  • Early-phase: biorelevant dissolution methods for enabling formulation technologies
  • Late-phase: robust and discriminative methods with aberrant batch support
  • Commercial registration: dissolution services meeting regulatory requirements

Biorelevant Dissolution

We have expertise in a broad range of biorelevant dissolution techniques including two-phase systems and flow-through methodologies, ensuring media representative of human gastrointestinal fluids.

03 Manufacturing

Drug Product Manufacturing

We operate state-of-the-art GMP facilities for clinical and commercial manufacturing in both the EU and the US. Our capabilities include conventional as well as highly specialized pharmaceutical manufacturing technologies. Our facilities are equipped to handle a wide variety of drug products including highly potent compounds and controlled substances.

A Dosage Forms

  • Solutions and (nano-)suspensions
  • Powder blend and granule-filled capsules
  • Tablets
  • Sachets
  • Multi particulates filled in capsules
  • Mini-tablets
  • Bilayer tablets
  • Orally Disintegrating Tablets
  • Semi-solid and liquid-filled capsules
  • Topical products

B Manufacturing Capabilities

  • Pre-clinical batches
  • Non-GMP pilot batches
  • GMP clinical supplies
  • Validation batches
  • Commercial manufacturing

C Specialist Capabilities

  • Modified release (matrix, osmotic, gastro retentive)
  • Pellets and microspheres, including coated blends
  • Spray Drying
  • Hot Melt Extrusion
  • Extrusion spheronization
  • Fluid bed processes
  • Powder blends for reconstitution
  • Over-encapsulated products
04 Stability

Drug Product Stability Studies

Stability studies are an essential component of pharmaceutical development. We have the capabilities to evaluate drug stability in a range of environmental conditions with changes in humidity, temperature, and light.

Our ICH-compliant stability storage facilities consist of over 100 m³ of walk-in stability rooms, fully secured with 24/7 electronic monitoring, alarm, and backup power at our EU and Somerset, US sites.

We can execute

  • 01 ICH stability studies and testing
  • 02 Accelerated studies (ASAP)
  • 03 Photostability studies
  • 04 In-use stability studies
  • 05 Ongoing stability studies

Small Molecule Development

End-to-end program management from process development through clinical supply. Our integrated platform covers API synthesis, solid-state research, formulation development, analytical services, and GMP manufacturing.

Discuss Your Program
Key Capabilities
Process Chemistry & Scale-Up
Polymorph & Salt Screening
Oral & Injectable Formulations
Analytical Method Development
GMP Manufacturing
Clinical Trial Supplies
Let's collaborate

We know development™
Let's talk about yours

Your program has a specific set of challenges. Our scientists want to hear them. Get in touch and we'll set up a direct conversation with the right expert.

Direct contact

info@ardena.com