Taking your discovery to a clinic-ready product
LLS Health believes formulation is a data-driven science and we follow a methodical and efficient approach in the delivery of our services.
We are a leader in developing commercial-ready products for our clients. The process can begin at any stage and includes any or all of the following: preformulation, formulation, pre-clinical production (including GLP test articles), scale-up, clinical trial material manufacturing, and commercial production.
We are technology agnostic and tailor our approach to deliver the best solution for our clients.
Equipment, expertise, experience
LLS Health has the equipment, expertise, and experience to take on your complex formulation challenges. We have spent decades accepting challenges that others would not. We have successfully developed delivery systems for difficult-to-formulate active pharmaceutical ingredients (APIs) across a wide range of indications and sites of action.
We work with clients to advance their new chemical entities (NCEs), ANDAs, 505(b)(2)s, and even over-the-counter products, ranging from nanoparticulate formulations to multiphasic emulsions and microsphere depot injections. Our team formulates small molecules and biologics, specializing in complex drug delivery with a focus on BCS II-IV molecules.
We work with the most difficult-to-formulate APIs to maximize bioavailability, control release rate, and enhance stability.
A legacy in formulation
Since 1991, we have been developing liquids, suspensions, powders, solid solutions, semisolid formulations, and long-acting implantable devices – both biodurable and biodegradable.
Innovators in nanotechnology and microparticle formulation
We have been at the forefront of nano- and microparticulate drug delivery. Our efforts have resulted in commercial nanoparticle products at scale. Whether it’s our proprietary technology or conventional systems, our staff knows how to apply these tools to meet your needs.
We support a wide range of dosage forms, including those that are sterile, non-sterile, and aseptically processed. We also handle DEA-controlled substances (Schedules I – V) and highly potent compounds (HPAPIs).
We use modeling and a DoE (Design of Experiments) approach and incorporate QbD (Quality by Design) to develop products with robust formulations and regulatory packages.
Our team has been at the forefront of drug delivery for decades and has learned first-hand that no single approach solves all problems. We readily utilize conventional methods and have both in-house and in-licensed technologies that can be used to develop products that meet your target product profile.
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.
We offer GMP manufacturing for many dosage forms, and our integrated approach creates a smooth transition from pre-clinical activities through clinical validation. We have GMP manufacturing space that is supported by in-house analytical services, bioanalytical services, physicochemical characterization, and ICH-compliant stability programs.
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.