Taking your discovery to a clinic-ready product
Drug Release Testing Services
LLS Health provides a complete suite of drug release assays for a variety of dosage forms, ranging from depot formulations to implantable devices and oral solid dosage forms.
Our GMP/GLP facilities are equipped with a wide range of state-of-the-art instrumentation and experienced technical staff to perform in vitro method development, characterization, and routine and specialized drug release testing.
High quality method development
A well-designed drug release method can accelerate formulation development by highlighting lead prototypes based on the desired release rate and a product’s critical quality attributes. Our analytical team can develop test methods from square one for a range of complex dosage forms including IVRs, drug depot injections, topical applications, and polymeric drug-eluting devices —from preliminary prototypes through commercial products.
Experience in drug release testing
We have been performing drug release testing to support client projects for over two decades.
Expertise in complex dosage forms
Over 80% of our drug release testing is performed on complex dosage forms. We have unique capabilities designed to meet the needs of virtually any route of administration, whether it be oral, implantable, parenteral, transdermal, etc.
Our scientists have access to a wide range of analytical equipment, from USP Apparatuses to non-compendial incubator shakers and in-house Flow-Through Cell Apparatus 4 for drug-device combination products.
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.
Our analytical services range from early stage method development through commercial validation. We are expert in complex sample preparation, and our experienced staff will help you design and execute a phase-appropriate analytical strategy.
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.
Our formulation team employs a data-driven approach to find solutions for even the most challenging APIs employing a range of technologies to maximize bioavailability, control release rate, and enhance stability. Our scientists work on projects from early-stage development through scale-up and transition to our clinical and commercial manufacturing teams.