Implantable Drug Delivery Systems and Combination Products
LLS Health is a leading developer of biodegradable and bio-durable implantable devices and vaginal rings. We have led the way in vaginal ring design for over 20 years, developing and co-patenting a contraceptive device now being marketed in Europe. Our team is also well-versed in subcutaneous implants, intravitreal implants, films, and intermediates such as dexamethasone-loaded silicone.
Polymer agnostic and customer-focused
Our scientists have experience with a broad range of active pharmaceutical ingredients (APIs) and polymers, including poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), thermoplastic polyurethane (TPU), ethylene vinyl acetate (EVA), and silicones (LSR and HCR). We have preferred relationships with the world’s leading polymer suppliers and are adept at polymer selection. Our team will find the right material for your application, ensuring the success of your product and creating a seamless path to commercialization.
While we are polymer-agnostic and select polymers based on target product profiles, we also manufacture a line of thermoplastic polyurethane excipients called Pathway™ TPU. Pathway TPU comes in both hydrophobic and hydrophilic varieties as well as a low-melt temperature version for drug-eluting systems containing thermolabile APIs. Pathway excipients are manufactured in compliance with IPEC-PQG good manufacturing practice guidelines for pharmaceutical excipients and GMP versions have drug master files with the FDA, which include a series of biocompatibility test results, stability data, and other CMC information to support regulatory filings.
Broad capabilities with deep experience
We have a wide range of in-house equipment and expertise with different manufacturing techniques and device designs, including matrix, reservoir, and coated products. We will adapt our approach to meet your target product profile to obtain the performance you require.
Our techniques for implantable device development 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
- Physical characterization
The products developed at LLS Health go far beyond simple small molecules. We can handle highly potent compounds such as hormones and steroids along with DEA controlled substances (Schedule I – V).
An advanced, multidisciplinary development strategy
The LLS Health development team employs statistical modeling tools to predict the efficacy of our designs, reducing the amount of development time to reach your desired target product profile.
Our many years of experience mean we can often foresee challenges and tackle them before issues arise. Close collaboration and communication between our analytical and formulation teams allows for quick and seamless troubleshooting. Our seasoned analytical staff are expert at method development and validation, creating methods that are representative, sensitive, and reproducible. The ability to reliably measure critical quality attributes such as in vitro drug elution and chemical stability have contributed to our strong reputation in the implantable drug delivery space.
Intellectual property opportunities
LLS Health can leverage our decades of formulation knowledge and experience to facilitate intellectual property (IP) opportunities for new chemical entities (NCEs), line extensions, and generics. Where devices already exist, we can develop new approaches to provide patent protection and freedom to operate. If an ANDA or 505(b)(2) filing is your goal, our formulation team will work closely with our analytical group to demonstrate equivalent performance to a reference listed drug product (RLD). Our portfolio of drug delivery technologies and polymer options provide you with multiple IP pathways.
Drug / Device Combination Products
We have decades of experience in the design, development, manufacturing, and characterization of drug-device combination products, including those that contain highly potent APIs and controlled substances. We offer advanced modeling tools, polymer processing, and sterile manufacturing to support new chemical entities, 505(b)(2) applications, and ANDAs.
We are adept in working with complex dosage forms, ranging from intravitreal injectables to topical nanosuspensions to long-acting implantables. Our data-driven approach allows us to develop a robust characterization plan for your product.
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.