Solutions and Suspensions
LLS Health provides a comprehensive suite of services for the development and manufacturing of liquid dosage forms, including solutions and suspensions. We have the quality systems, infrastructure, and capabilities that create a low risk pathway to commercial production for even the most complex formulations.
Unrivaled expertise in sterile and complex dosage forms
Our flexible but precise approach allows us to work with almost any dosage form, sterile and non-sterile products including both topical and parenteral products. Whether you are developing a generic or formulating a new chemical entity (NCE), we have experience developing and manufacturing everything from simple solutions to complex nanoparticulate suspensions. Our formulation team is complemented by a seasoned quality department and a best-in-class analytical team who develop and validate methods to reliably measure critical quality attributes, such as drug degradation and release rate.
Our comprehensive capabilities include full release testing and ICH stability programs for solutions and suspensions, as well as pre-clinical, clinical, and commercial GMP manufacturing. This applies to a range of products, including those that are sterile, highly potent, and/or DEA controlled (Schedule I – V).
We can support the formulation and commercialization of simple solutions, suspensions, and have substantial experience in developing complex liquid dosage forms containing water-insoluble active pharmaceutical ingredients (BCS Class II – IV APIs).
Purpose-built manufacturing facilities
Our team considers downstream processing throughout development to ensure that scale-up is seamless. When the time comes to produce material for clinical trials or commercial supply, we have several clinical cleanroom suites as well as a purpose-built commercial manufacturing facility directly adjacent to our development site, offering customers a one-stop shop from concept through commercialization.
Analytical Method Validation
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 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.
Our purpose-built commercial manufacturing facility is ideally suited to sterile and complex drug products, including those with small batch sizes and sterility requirements. We have GMP manufacturing space that features a well-equipped processing room as well as Grade A filling and lyophilization suites.