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.
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.
We support the development and manufacturing of building blocks necessary for the preparation of nanoparticles in addition to active pharmaceutical ingredients.
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:
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.
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.
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.
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.
Our expert team members share their deep, scientific understanding and insights into nanomedicine development and manufacturing
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.