The anatomy and chemical composition of the eye provide known constraints to pharmaceutical penetration. Many drug products struggle to penetrate the target tissue, such as the cornea or retina, resulting in poor bioavailability.
LLS Health is well-equipped to help you overcome these challenges for delivery to both the anterior and posterior segments of the eye. We supply both high-performance excipients and contract development and manufacturing services for the complex dosage forms utilized in the ocular space.
Sterile products and aseptic processing
Due to the delicacy of the human eye, every ophthalmic drug product must meet high sterility requirements. With decades of experience in this area, LLS Health provides complete drug product services to meet your ophthalmic needs. We produce a variety of dosage forms via aseptic processing using either clinical or commercial cleanrooms. Our capabilities include aseptic fill-finish, highly-potent and biological compound handling, and manufacturing a variety of dosage forms such as drug-eluting devices, intravitreal injectables, and ophthalmic suspensions.
Exploring different pathways
Ophthalmic drug delivery is a rapidly growing area and provides an ideal opportunity to innovate. We have experience successfully working with large pharma companies, innovative start-ups and non-profit organizations on the development and manufacturing of ophthalmic drug products. And as a leading partner in ocular innovation, we have the experience and capabilities necessary to fully support our clients should they choose to explore novel pathways, such as, drug/device combination products, 505(b)(2) opportunities, or sustained-release formulations, among others.
LLS Health manufactures a portfolio of polymer excipients to help achieve your ocular drug delivery goals. We offer both mucoadhesive excipients for topical eye drops, gels, and ointments as well as implantable, bio-durable polymers for drug/device combination products, such as intraocular inserts and punctal plugs.
Carbopol®, Pemulen™, and Noveon®
As a leader in inactive ingredients, our Carbopol, Pemulen, and Noveon excipients have delivered trusted quality to the pharmaceutical industry for more than 40 years. These products provide essential properties for effective ocular delivery, for example, excellent suspension, viscosity, and rheology control, including superior mucoadhesive properties, allowing for longer contact time with the eye and therefore enhanced efficacy.
Our Pathway thermoplastic polyurethane (TPU) is well-suited for drug-eluting devices and long-acting technologies seeking to achieve controlled, sustained therapeutic delivery.
Pathway is compatible with a broad spectrum of active pharmaceutical ingredients (APIs) and possesses flexible chemistry to allow for customization to meet your needs. Non-biodegradable polymers such as TPU have been shown to provide better control of drug release than their biodegradable counterparts and have the distinct advantage of functioning over longer time points.
We employ several 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 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.
Our development and manufacturing services are complemented by well-designed, ICH-compliant stability programs that accommodate a range of temperature and humidity conditions. We have also invested in a state-of-the-art electronic lab management system that enhances data reporting and statistical analysis.