Drug Product Development and Manufacturing

Services Drug Product

Drug Product Development and Manufacturing

We advance your clinical candidates through the pipeline quickly and safely with expert drug product services, whether you are looking for the development of a fit-for-purpose pre-clinical formulation or the manufacture of clinical trial material.

Driven by science. Diligent. We guide you down the smartest path to meet your molecule’s milestones on time.

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.

Drug Product Formulation Development

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.

Solving a problem and saving time, overcoming your development challenges is our specialty. We work with you to understand your product needs and develop the best possible formulation.

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

Oral dosage forms

API in capsule/vials
Powder blend in capsules
Liquid in capsules
Immediate or modified release tablets/capsules
- Monolithic dosage forms
- Multiparticulates
- Gastro retentive tablets
- Osmotic tablets
Mini tablets
Orally disintegrating tablets
Solutions and suspensions
Sachets
Pediatric oral dosage forms
Bioavailability/solubility-enhancing technologies, including:
- Nanosuspensions
- Amorphous solid dispersions:
  - Spray dried amorphous solid dispersions
  - Hot Melt Extrusion amorphous solid dispersions
- Lipid-based formulations

Injectable dosage forms

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

Topical and nasal dosage forms

Topical (solutions, creams, ointments)
Nasal (sprays, inhalants)

Drug Product Analytical Development

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, with phase-appropriate methods validated in compliance with ICH guidelines to ensure expedited product development.

Our expertise spans chromatography capabilities, dissolution studies, Karl Fischer methods, and microbiology testing, among others. All GMP analytical testing methods are validated using a staged and phase-appropriate approach, ensuring the highest standards of quality and efficiency throughout your development process.

Chromatographic methods

Our product analytical services offering includes chromatography capabilities using state-of-the-art equipment.

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 a solid dosage form and needs to be kept in mind during pharmaceutical development.

Whether the dosage form is immediate release or modified release, we offer dissolution method development support, using state-of-the-art USP-1, USP-2 and USP-4 equipment.

Our dissolution testing services span all phases of drug development:

Early-phase clinical projects, especially where enabling formulation technologies are applied, we develop biorelevant dissolution methods.
Late-phase clinical projects, we develop robust and discriminative methods. For this purpose, aberrant drug product batches are manufactured to support the dissolution method development.
Commercial registration, we offer the necessary dissolution services to meet regulatory requirements.

Biorelevant dissolution

During drug development, the selection of the most effective formulation must be supported by effective biorelevant dissolution testing. It is important that the media used in these dissolution setups are representative of the human gastrointestinal fluids.

We have expertise in a broad range of biorelevant dissolution techniques including two-phase systems and flow-through methodologies.

Drug Product 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.

From our cutting-edge facilities to our expert teams, we are engineered to deliver exceptional performance. We provide consistent non-GMP and GMP drug product manufacturing services, adhering to the highest standards while meeting your timelines.

Our facilities are equipped to handle a wide variety of drug products including highly potent compounds and controlled substances.

Dosage forms we manufacture

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

Manufacturing capabilities

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

Specialist capabilities

Modified release
Matrix modified release
Multiparticulates
Osmotic modified release tablets
Gastro retentive tablets
Pellets and microspheres, including coated blends
Spray Drying
Hot Melt Extrusion
Twin Extrusion processes
Extrusion spheronization
Fluid bed processes
Powder blends for reconstitution
Over-encapsulated products

Drug Product Stability Studies

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:

ICH stability studies and testing
Accelerated studies (ASAP)
Photostability studies
In-use stability studies
Ongoing stability studies

Related resources

Our experts share their deep, scientific understanding and insights into drug product development and manufacturing.

All Info sheets Case studies Whitepapers Webinars Expert Q&A Insights Application Note

See all resources

Hot Melt Extrusion for Poorly Soluble Drugs: Formulation Strategies and Scale-Up Insights

A CDMO’s insight on amorphous solid dispersions

Accelerate Your Path to Preclinical Trials

On-demand webinar: Breaking the Bioavailability Barrier: Formulation strategies for Improving API Solubility

On-demand webinar: Compatibility and In-Use Stability Studies for Injectables

Phase-appropriate analytical method development

On-demand webinar: Capsules, a versatile OSD for early phase development

Fill & Finish Services

Driving your lead candidate to clinic

Facilitating clinical trial success for drug products

Phase-appropriate development of a phase 1 oral dosage form

Leverage the power of CMC in early drug development

Formulation and Process Considerations for Optimising Spray-Dried Solid Dispersions

Much more than just smoke - from marijuana to medicinal cannabis derived therapeutics

Applying the science of advanced dissolution testing to accelerate product approval

Discriminatory dissolution test method in late development

Which solubility-enhancing technology should I use to support my early drug development project?

Powder blending in early-phase drug product development: Balancing art and science

Your molecule, your journey, our mission.

Get in touch to see how we can craft your path to the clinic with dedicated capabilities.

Get in touch

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