The trusted partner who pioneers drug / device combination product solutions
Drug / Device Combination Products Services
LLS Health works in partnership with you to meet the formulation and development needs of your drug-device combination product.
Our teams provide the design, formulation, and manufacturing services required to achieve your therapeutic goals, whether you are looking to achieve long-acting drug release, targeted delivery, lower dosage requirements, or improved patient compliance.
Biodegradable and biodurable polymer processing
We design systems for new chemical entities (NCEs), 505(b)(2) generic applications, and ANDAs. Our facility is equipped with cleanrooms for sterile implantables, highly potent compounds (hormones, steroids, cytotoxics), and Schedule I-V controlled substances, offering complete design to commercialization for even the most complex implantable drug delivery systems.
Our polymer processing capabilities include:
- Hot melt extrusion (HME)
- Co-extrusion (for the development of core-sheath devices or multi-layer extrusions)
- Injection molding
- Cryo-milling and jet milling
- Surface dip and spray coating
- High-shear mixing
- Wet granulation
- Spray drying
- Physical characterization
We have established relationships with the world’s leading suppliers of both biodegradable (PLGA, PLA, PGA, PCL, etc…) and nonbiodegradable (TPU, EVA, silicone, etc…) polymers, ensuring a seamless path to commercialization. For nonbiodegradable systems such as vaginal rings, subcutaneous implants, and implantable sensors, we also manufacture highly customizable Pathway™ TPU excipients that are compatible with a wide range of APIs.
Our unique pre-formulation approach uses empirically collected data and proprietary computational modeling to predict how factors such as device design and polymer chemistry will affect drug release. This expedites the development process and reduces the number of prototypes needed to achieve a target product profile.
LLS Health’s seasoned analytical services team has a wealth of experience in method development and validation for combination products. They are well-versed in USP guidelines and custom method development, such as measuring in vitro drug release from novel vaginal rings. Our analytical staff also supports our long-term and accelerated ICH stability programs.
Extensive in-house capabilities
We offer extensive in-house capabilities to meet all your drug-device combination product needs including extensive drug release modeling, compounding, polymer processing techniques, physical/chemical characterization, and ICH stability programs.
A data-driven pre-formulation approach
Based on a combination of empirically collected data and proprietary computational modeling, our approach predicts drug release from implants and vaginal rings, guiding formulation development. This reduces both the time and resources required, helping you get to market faster.
Equipped for your API, polymer, and process
Our team has experience working with a range of polymers and APIs, including highly potent APIs and controlled substances. We are also experts in technology transfers, often bringing processes from the benchtop into a GMP environment using our on-site clinical and commercial GMP manufacturing suites.
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.
Analytical Method Development and 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.
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.