Nanomedicines development and manufacturing

Services Nanomedicines

Nanomedicines development and manufacturing

We help you scale up to clinical schedules on time, guiding your nanomedicine candidate through its journey to the clinic and de-risk development with expertise encompassing scalable formulation, process and analytical development.

Decomplicating Nanomedicines

This fast-evolving field uses nanoscale or nanostructured materials to impart unique pharmacokinetic and therapeutic effects such as targeted delivery, enhanced efficacy and reduced toxicity.

Our team members have a unique scientific understanding of nanomedicines having advanced a range of formulations into the clinic. We bring this expertise to your project, using established methodologies and innovating when needed to give you the best possible outcomes.

De-complicating your projects with an integrated approach, our experts take ownership of the technology transfer of your existing process and the implementation of cGMP manufacturing as well as the synthesis of your lipids, polymers and other building blocks.

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Synthesis of building blocks

Synthesis of building blocks

We support the development and manufacturing of building blocks necessary for the preparation of nanoparticles in addition to active pharmaceutical ingredients.

This includes:

Custom lipids
Monomers
Polymers
Inorganic complexes

Nanoparticle expertise

Nanoparticle expertise

We integrate analytical development for these APIs and building blocks alongside nanoparticle development to accelerate and de-risk your program.

We are experts in the following nanoparticles:

Liposomes, lipid micelles and lipid nanoparticles
Polymeric micelles and polymeric nanoparticles
Iron oxide nanoparticles
Silica nanoparticles
Gold nanoparticles

Nanomedicine Process Development

Nanomedicine Process Development

Our scientists develop phase-appropriate production processes in accordance with cGMP and mitigate technology transfer issues by using the same teams for development and manufacturing.

Techniques include:

Flow manufacturing
Batchwise synthesis
Tangential flow filtration
Magnetic separation
Single-use purification systems
Low bioburden and sterilizing filtrations

GMP Nanomedicine Production

GMP Nanomedicine Production

In our cGMP-compliant manufacturing facilities, we can produce volumes of a couple of milliliters to up to 300L in some instances, using batch-type and flow manufacturing processes.

We can handle highly potent drug substances in carefully engineered facilities and can deliver nanosuspensions and nanoparticle solutions as sterile finished drug products in vials or syringes.

Analytical Development

Analytical Development

We are intimately familiar with defining the critical quality attributes (CQAs) of nanomedicines. To evaluate the CQAs of your GMP-produced drug products and to support product development, we utilize state-of-the-art analytical techniques.

We perform ICH-compliant stability testing of nanomedicines, APIs and novel excipients using stability indicating methods.

Analytical techniques used

Dynamic light scattering,
Small-angle X-ray scattering
Capillary electrophoresis
Zeta-potential measurements
Transmission and scanning electron microscopy
Dynamic light scattering, small-angle X-ray scattering and laser diffraction
Asymmetric flow field-flow fractionation – multi-angle light scattering (AF4-MALS)
Size exclusion chromatography
Zeta potential measurements
Nuclear magnetic resonance, infrared and Raman spectroscopy
HPLC/UPLC

Dossier Development and Strategic Regulatory Support

Dossier Development and Strategic Regulatory Support

Having advanced a wide range of nanomedicine formulations into the clinic, we are used to developing new manufacturing techniques and analytical procedures under fierce regulatory scrutiny.

Our dossier-oriented approach combined with deep understanding of the regulatory landscape gives your nanomedicine project the greatest chance of approval.

Related Resources

Our expert team members share their deep, scientific understanding and insights into nanomedicine development and manufacturing

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

See all resources

Leading the Way in Nanomedicine Solutions

On-demand webinar: Mastering Nanomedicines Characterization: Techniques for Determining Particle Size Distribution Based on Dynamic Light Scattering

Using Flow Technology in Nanoparticle Synthesis

Advancing oligonucleotide therapeutics with cutting-edge bioanalytics

Deciphering the complex characteristics of nanoparticles by asymmetric flow field-flow fractionation

Navigating the CMC Regulatory Landscape for Oligonucleotide Therapeutics

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.