Microparticle and Gel Depot Injections
LLS Health is a leader in the development of long-acting depot injections—including bioresorbable microparticles/microspheres and in situ forming gels. From initial lab assessment and pre-formulation to formal development, scale-up, GMP clinical trial production, and commercial manufacturing, we have the capabilities and expertise necessary to accelerate your depot injection to market.
Broad experience in polymeric drug delivery
LLS Health offers comprehensive services in the development and manufacturing of long-acting depot injections. We are expert at handling both large and small molecules and specialize in developing intricate drug products, such as intra-articular, subcutaneous, or intravitreal injectables, including controlled-release systems and biodegradable formulations.
Our team has experience with a broad range of active pharmaceutical ingredients (APIs) and polymers, including poly(lactic-co-glycolic acid) (PLGA) and polylactic acid (PLA). We understand how to formulate and characterize these polymers to support Q1/Q2 evaluations of generics and the development of new chemical entities (NCEs). We are polymer agnostic and have preferred relationships with the world’s leading polymer suppliers.
Flexible formulation and manufacturing capabilities
LLS Health has several microsphere and gel formulation and manufacturing technologies that allow us to explore different approaches for your product. With a portfolio of options to choose from, we use a combination of data and experience to find the approach that best achieves your technical and commercial goals.
Our techniques for depot injection formulation and manufacturing include:
- Emulsion – solvent evaporation
- Emulsion – solvent extraction
- Spray drying
- Coacervation/phase separation
- Jet milling
- Augmented drip casting
Support through the entire development process
Our development expertise is combined with the supporting services and facilities to accelerate your product from concept through commercialization. LLS Health manufactures GMP material for clinical trials (phase I, II and III) and commercial supply. We are expert in aseptic manufacturing and sterile fill-finish, and we can handle batch sizes ranging from gram to kilogram scale. Our purpose-built commercial manufacturing facility is equipped with flexible processing space, an aseptic filling suite, and lyophilization technology, allowing a seamless flow from R&D through commercial production.
Our seasoned analytical staff are expert at method development and validation, creating methods that are representative, sensitive, and reproducible for each customer project. The ability to reliably measure critical quality attributes such as in vitro drug elution and chemical stability make LLS Health an ideal partner for long-acting depot injection development.
We are skilled in the formulation, manufacturing and analytical characterization requirements for microsphere and gel products and our team is motivated to progress your product to the desired endpoint.
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.
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.