Delivering Change

Manufacturing made simpler. Drug delivery made easier.


Trelyst was founded to be a different kind of CDMO. We’re constantly innovating silicone combination drug delivery platforms to improve medication adherence rates. By leveraging the chemical degrees of freedom possible to tailor silicone, we’ve created a comprehensive, start-to-finish development process designed to take your drug product to the next level—and get it to market ­­­faster than ever.

Trelyst was founded to be a different kind of CDMO. We’re constantly innovating silicone combination drug delivery platforms to improve medication adherence rates. By leveraging the chemical degrees of freedom possible to tailor silicone, we’ve created a comprehensive, start-to-finish development process designed to take your drug product to the next level—and get it to market ­­­faster than ever.

Concept

A great idea can do a world of good.

During our Concept phase, we work with you to set your adherence goals and follow quality-by-design principles to create a custom silicone structure capable of hitting those targets. Our silicone scientists analyze the molecular interactions between your drug and our array of silicone systems to find an ideal architecture for the long term release of your drug.

    Support during the Concept phase includes:

  • Project Planning
  • Defining Adherence Goals
  • Building a Drug Device Combination Target Profile
  • Silicone Drug Interaction Analysis
  • Silicone Excipient Design and Pre-formulation Testing
  • Intellectual Property Strategy
  • Global Regulatory Planning for Combination Products
  • Early Stage Risk Analysis
  • Pre-formulation Established

Research

Here’s where it all starts to take shape.

In the in-vitro Research phase, we use the degrees of freedom afforded by silicone chemistry to find the optimum formulation for sustained delivery of your drug. We test your compound against a variety of silicone polymers, reactive sites, and additives to create the most effective custom silicone network.

Our silicone expertise accelerates this development and allows us to define precise controls for drug release. With this advanced on-site silicone testing and our in-depth knowledge of combination drug devices, we’re also able to author the drug master file early and get ahead of any potential regulatory speed bumps. At the end of the Research phase, we can comfortably control the initial burst release and the steady state release to ensure efficacy and minimize risk.

    Support during the Research phase includes:

  • Prototype Design Requirements
  • Test Method Development for Drugs Embedded in Silicone
  • Silicone Formulation Development for Sustained Release
  • Long Term Release Modeling
  • Quality by Design Model Iteration
  • Excipient Master File Creation
  • Drug Device Combination Strategy
  • Technical In-vitro and Preclinical Feasibility Established and Optimized

Development

Transforming your treatment.

With every step in the Development phase, your product gets closer to making a difference. Our engineering expertise and state-of-the-art silicone processing allow us to rapidly create a combination drug delivery device for humans that provides a sustained release and is ready for clinical studies.

Using our revolutionary integrated process, we run models that predict drug release to accelerate decision-making and take any steps necessary to avoid costly delays and setbacks. As your product moves through Phase I - III testing, our product development and regulatory team supports filing submissions and helps navigate the Office of Combination Products.

    Support during the Development phase includes:

  • Human Drug Device Design
  • Preclinical Testing
  • Clinical Trial Manufacturing
  • Manufacturing Process, Validations, and Verifications
  • Clinical Trial Support
  • CMC Support
  • Regulatory Submission
  • Manufacturing Scaling Plan

Commercialization

A shorter path to market.
A shorter path to wellness.

At the end of the day, it’s our job to help get your combination drug device to the patients who need them quickly and efficiently. During the Commercialization phase, that means implementing large-scale automated silicone manufacturing processes that can produce large quantities with high yields.

We leverage the silicone design, formulation, and development of your combination product to cost-effectively scale. By using the same facility, staff, and processes from concept to commercial, we minimize regulatory delays associated with changes in sites and scale.

    Support during the Commercialization phase includes:

  • Design Transfer
  • Process Risk Analysis
  • Silicone Device Scaling Strategies
  • Regulatory Comparability Programs for Scale Changes
  • Scaled Manufacturing to Meet Launch and Commercial Requirements
  • Annual Regulatory Reporting
  • Continuous Improvement Programs
  • Post-market Support

Making a difference means doing things differently.

Got a drug that needs life cycle extension or better patient adherence?

Let’s talk about your ideas.