The trusted partner to take your discovery to the clinic and beyond with physical characterization solutions
Physical Characterization Services For Drug Products
LLS Health is a leader in physical characterization of drug products. We have been at the cutting edge of regulated solid state characterization for decades.
With growing frequency, regulators are requiring tight control over parameters such as particle or droplet size, viscoelastic properties, and the correlation of these properties to efficacy. Based on this understanding, LLS Health is positioned to address these regulatory challenges. Our facility operates under GLPs/GMPs, has highly potent API handling capabilities, and is FDA-registered and DEA-licensed for all schedules of controlled substances.
Well-equipped laboratory facilities
LLS Heath’s physical characterization lab is a natural extension of our analytical capabilities. We support formulation development and monitor stability through particle size distribution (laser diffraction and dynamic light scattering), rheological analysis, and solid state characterization. We have in-house expertise with HPLC, FTIR, DSC, TGA, LC/MS, Raman microscopy, and other methods that support evaluations of key properties such as crystallinity and solubility.
We are adept in working with complex dosage forms, ranging from intravitreal injectables to nanosuspensions to long-acting implantables and so on. With decades of drug-device combination product development experience, we are uniquely positioned to perform mechanical property testing on products such as vaginal rings and subcutaneous implants.
Our data-driven approach allows us to develop a robust characterization plan for your product. And, our experience with a broad range of APIs and drug products ensures that suitable methods are selected.
Integrated with formulation
Our physical characterization and formulation teams work together to support and expedite formulation development.
Unrivaled knowledge and expertise in particle size analysis
For decades, LLS Health has been at the forefront of regulated fine-particle and nanoparticle characterization.
Unique capabilities
Our equipment is extensive, including a XiGo Nanotools Acorn Area™, Malvern and Horiba particle size analyzers, a Brookfield viscometer, and state-of-the-art TA DHR rheometers, among others. We also have a wide breadth of techniques, such as FTIR spectroscopy, optical and Raman microscopy, and DSC/TGA.
Additional Physical Characterization Services
To help control variations in raw materials that affect performance, our scientists can help:
- Qualify suppliers
- Identify critical parameters of excipients and active substances
- Develop and validate characterization methods
Supporting Capabilities
LLS Health is a flexible, full-service CDMO, offering formulation development, drug product manufacturing with supporting analytical services and quality oversight as well as professional project management. We can help you every step of the way from concept through commercialization.
Drug-Device Combination Products
We have decades of experience in the design, development, manufacturing, and characterization of drug-device combination products, including those that contain highly potent APIs and controlled substances. We offer advanced modeling tools, polymer processing, and sterile manufacturing to support new chemical entities, 505(b)(2) applications, and ANDAs.
We employ several microsphere and nanotechnology approaches, designing custom programs around specific APIs and client goals. Our team is uniquely positioned to transfer in proprietary technologies or processes and bring them into GMP production. We can produce micro and nanoparticle dosage forms under aseptic conditions at clinical and commercial scale.
ICH-Compliant Stability Programs
Our development and manufacturing services are complemented by well-designed, ICH-compliant stability programs that accommodate a range of temperature and humidity conditions. We have also invested in a state-of-the-art electronic lab management system that enhances data reporting and statistical analysis.