Process Development CDMO · Miami, FL

Helping Innovators Scale from Lab to Production

Lyoworks is a US-based process development CDMO built for early-stage innovators. Formulation, freeze-dry cycle development, and pilot-scale aseptic fill-finish for temperature-sensitive and biologically complex compounds.

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Built for the Teams That Big CDMOs Won't Support

Most contract development organizations are designed for established pharma companies with large pipelines and institutional budgets. If you're an early-stage team with a promising compound and a small batch, they're not built for you.

Lyoworks is.

We work directly with founders, researchers, and small development teams to take sensitive compounds from the bench toward a documented, reproducible, production-ready process. No minimum program size. No institutional gatekeeping. Just focused technical partnership from formulation through pilot-scale manufacturing.

Explore Services

Team observing cleanroom equipment at Lyoworks

What We Do

Core Services

Three integrated capabilities — from characterization through pilot-scale manufacturing — to move your compound from lab to production.

HPLC and mass spectrometry analytical system

Analytical Characterization

We characterize your compound's thermal behavior, moisture content, purity, and stability profile — building the data foundation that every downstream decision depends on.

Thermal analysis (DSC)
Residual moisture & Karl Fischer titration
HPLC purity & potency assays
Moisture sorption profiling
Cake quality & reconstitution assessment
Accelerated & real-time stability studies

Formulation & Freeze-Dry Development

From excipient screening through optimized lyophilization cycles, we develop formulations and drying parameters that preserve potency and enable room-temperature storage.

Formulation screening & optimization
Thermal & freeze-drying microscopy
Controlled nucleation studies
Lyophilization cycle design & optimization
Process documentation & tech transfer packages

Pilot-Scale Aseptic Fill-Finish

Small-batch aseptic fills under controlled conditions, producing the process data, batch records, and documentation your next manufacturing partner needs to scale.

Aseptic vial filling & stoppering
Freeze-drying
Batch record generation
Process validation data packages
Technology transfer support

Why Lyoworks

A Different Kind of CDMO

The CDMO That Answers Your Call

Large contract manufacturers serve large clients. Lyoworks was purpose-built for the researchers, startups, and independent teams working at the earliest and most critical stages of development.

Process-First, Not Batch-First

Every engagement is designed to produce a documented, reproducible process — one that a downstream manufacturer can pick up, validate, and scale. You leave with more than product; you leave with a transferable process.

US-Based, Direct Access

Our development laboratory operates in Miami, FL. You work directly with the people handling your compound. No layers of project managers, no offshore handoffs, no black-box processing.

How We Work

From First Conversation to Transferable Process

Straightforward engagement. Direct communication. No institutional overhead.

Conversation

Tell us about your compound and goals. We'll tell you honestly whether we can help.

Scoping

Clear proposal with defined scope, approach, and timeline. No unnecessary phases.

Development

We execute in our Miami facility. Direct access to the scientists doing the work.

Documentation

Formulation records, cycle parameters, batch data — packaged for transfer.

Transition

We support the handoff to your downstream CDMO for commercial scale-up.

Who We Work With

Built for Builders

If you've been told your batch is too small, your program is too early, or you need to "come back later" — that's exactly where we start.

Early-Stage R&D Teams

Developing novel compounds and needing formulation science to move forward.

Startups & Founders

Bringing a product concept toward manufacturability without institutional overhead.

Independent Researchers

Small laboratories without in-house lyophilization or aseptic fill capability.

Companies Preparing to Scale

Need documented process data before approaching a larger CDMO for commercial manufacturing.

About Lyoworks

A Process Development CDMO Built for the Earliest Stages of Innovation

Lyoworks LLC is a US-based contract development and manufacturing organization focused on process development for temperature-sensitive and biologically complex compounds.

Our clients are typically early-stage: startups, independent researchers, small R&D teams, and founders developing novel compounds. The large CDMOs that serve established pharmaceutical companies often can't support small development batches or the kind of direct technical partnership that early programs require.

We were built to fill that gap.

Lyoworks facility at University of Miami Life Science & Technology Park

University of Miami Life Science & Technology Park Miami, FL 33136

A Note on Scope

Lyoworks operates strictly in the process development space. We do not prepare products for clinical use, patient administration, or consumer distribution. Projects focused on learning, manufacturability, process control, and technical risk reduction are a strong fit. Clear framing from the start helps both sides move forward efficiently.

Contact

Let's Talk

Whether you're exploring an idea or ready to start development, we're happy to have the conversation.

Get in Touch

Headquarters

University of Miami Life Science & Technology Park
1951 NW 7th Avenue, Suite 600
Miami, FL 33136

eutectic@lyo.works

Hours

Monday – Friday, 9:00 AM – 6:00 PM ET