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.

Science-led. Diligent. We guide you down the smartest path to meet your molecule’s milestones on time.

De-pressuring your clinical journey

Our experts provide drug product services through dedicated analytical, formulation development, manufacturing and scientific reporting teams. Our integrated capabilities are uniquely engineered to enable early phase development and support you all the way to market.

Our fully equipped drug product development facility houses separate analytical and formulation development laboratories as well as GMP accredited manufacturing suites. Our quality GMP manufacturing suites have sophisticated systems that ensure your drug products meet the highest quality standards. The site also has a state-of-the-art warehousing facility and separate packaging and labeling areas.

In addition, our facility has several walk-in stability testing rooms operated in accordance with ICH recommendations and has continuous monitoring systems capable of monitoring samples in real-time, 24/7.

We de-risk your path to the clinic by providing the most detailed data available with comprehensive formulation characterization and analytical services.

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
Orally disintegrating tablets
Solutions and suspensions
Sachets
Bioavailability/solubility-enhancing technologies, including:
- Nanosuspensions
- 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

Ensuring you have a complete understanding of product quality and stability is critical to the success of your drug development process

We offer a variety of analytical capabilities to support drug development, removing the need for additional partners and simplifying your supply chain.

Our areas of expertise include chromatography capabilities and dissolution studies, and we ensure that methods used for GMP analytical testing are validated according to ICH guidelines using a staged and phase-appropriate level.

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

From our facilities to our people, we are engineered to be top performers. We deliver consistent non-GMP and GMP drug product manufacturing services to the highest standards and to your timescales.

We can handle a variety of dosage forms including highly potent compounds and controlled substances with a specialism in small-scale batches.

Dosage forms we manufacture

Solutions and (nano-)suspensions
Powder blend and granule-filled capsules
Tablets
Sachets
Semi-solid and liquid-filled capsules
Topical products

Small-scale manufacturing

Pre-clinical batches
Non-GMP pilot batches
GMP clinical supplies
Validation batches
Commercial manufacturing of orphan/niche drugs

Specialist capabilities

Modified release
Pellets and microspheres, including coated blends
Spray-dried powders
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.

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

See all resources

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

Our integrated platforms

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.

Drug substance

Helping you turn your compounds that show promise into GMP-grade drug substances.

Drug product

We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.

Drug product

We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.

Drug product

We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.