Complete materials characterization is critical at all stages of drug formulation, development and manufacturing to ensure regulatory approval.
By blending analytical expertise with market-leading technological innovation, we provide a flexible and scalable materials characterization service that is much more powerful than the sum of its parts.
Our services enable drug developers to:
- Rapidly identify drug candidates that meet the requirements for bioavailability and processibility.
- Accelerate drug development timelines, reduce risks and ensure drugs are regulatory-review ready.
As we develop more complex drugs to tackle unchecked diseases, it’s harder to fully characterize these compounds. Just one small parameter, like particle size, can have big impacts when it comes to bioavailability, uniformity, stability and processability. And these parameters can become safety issues and manufacturing barriers.
Whether you’re working with pharmaceutical intermediaries, APIs, excipients or final formulations, characterization is key. But as compounds become more complex and regulatory requirements more multifaceted, assays require more cutting-edge equipment and in-depth analytical expertise.
It can be hard to handle complex characterization in-house, especially amid a shifting regulatory landscape. Missing out on particle size, morphology or physicochemical information could cause big issues when it comes to production or regulatory sign-off stages.
We start with your what. Considering the intended delivery and purpose of your drug candidate, what do you need to know to find the most promising candidates and get them to market faster? And then we work from there, bringing in the knowledge and tools to fully define every drug candidate, API, excipient or final formulation. We work flexibly and closely with your in-house team, scaling our work to fit your needs.
We provide integrated solutions where knowledge and technology meet to deliver optimal insight. Our analytical scientists are armed with years of specialist knowledge and have access to the very latest in cutting-edge equipment and techniques, leaving no characteristic undefined.
Just a few of our materials characterization services and specialist equipment and methods:
Particle and powder properties and characterization
Particle / powder properties and characterization
Particle characterization is a critical step in the development of solid-form and suspension formulations. Parameters, such as particle size distribution, mobility, charge and morphology can affect everything from the processing flowability of compounds to their deliverability and bioavailability.
We use the latest techniques in optical imaging, laser diffraction, dynamic light scattering and X-ray powder diffraction to characterize APIs, excipients and final drugs, working in the nanometer to millimeter range.
Discover our complete analysis packages and state-of-the-art equipment for particle and powder characterization.
When drug formulations are complex, pharmacokinetic studies may not fully define bioavailability or the exact behavior of a drug as it is stored, processed or used. To comply with many regulatory standards, rheological testing is a requirement, particularly when it comes to demonstrating equivalence in generics.
Our state-of-the-art rheometer services enable full characterization of drug formulations, even in complex states. Critical properties, such as viscosity, yield stress and viscoelasticity are all defined quickly and accurately, ready for submission.
Discover how we can help define your final drug product.
X-ray powder diffraction
X-ray powder diffraction services
Understanding the physical properties of a solid formulation is critical at every point on the drug discovery and development journey. As one of the industry leaders in X-ray powder diffraction (XRPD), we use cutting-edge technology to provide rapid, non-destructive analysis of solid forms.
Each solid form will create a unique diffraction pattern so even polymorphs can be quickly identified, allowing the drug to be optimized and any issues in development, scale-up or manufacturing identified.
Discover more about our expert analytical services, intelligent technology and robust refinement methods for industry-leading XRPD analysis.
We don’t shy away from the trickier characterizations
Characterization of Recombinant Adeno-Associated Viruses (rAAVs) for Gene Therapy Using Orthogonal Techniques
Discover how dynamic light scattering helped our client better characterize adeno-associated viruses for gene therapy.
By combining analyst expertise with cutting-edge technology, we’ve made materials characterization a drug development enabler. We’ve helped countless clients get their products to market faster through a deeper understanding of their drug profile. Find out how we can help you.
Are you ready to start your journey with us?
Are you developing generic or complex generic products and looking for ANDA submission support? See how we can help here.
Our Solid Form Screening services support early phase API development, from solid form optimization through pre-formulation to pre-clinical formation - discover more here.
Get in touch to speak with our team of materials characterization experts.