Ophthalmic CDMO

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.

Particle Sciences is well-equipped to help you overcome these challenges for delivery to both the anterior and posterior segments of the eye. We supply 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, Particle Sciences 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.

Related Services

Nanotechnology

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.

Formulation

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.

Commercial
Manufacturing

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.

ICH-Compliant Stability Programs

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.