How We Make Our Suspensions

A continuous, rapid process that turns protein formulations into high-concentration, injectable suspensions.

Lindy Biosciences microglassification technology

Mix. Concentrate. Suspend.

Lindy's proprietary suspension platform is produced using the microglassification process — a continuous, rapid method that concentrates protein formulations into dense, stable particles at ambient temperature. The result is a high-concentration biologic suspension that can be administered via standard subcutaneous injection: a simple syringe or pen that patients can self-administer at home.

Step 1

MIX

Protein solution is combined with organic solvents in a rapid, controlled process at ambient temperature — with precise control over kinetics and particle size.

Step 2

CONCENTRATE

The process rapidly concentrates the protein, producing dense, stable particles within seconds.

Step 3

SUSPEND

Particles are formulated into a suspension vehicle and filled into pre-filled syringes or vials — ready for subcutaneous delivery via standard drug delivery devices.

Why suspensions beat solutions.

At high concentrations, protein solutions become too viscous to inject or too unstable to maintain shelf life. Suspensions take a different approach — separating molecular stability from injectability, and optimizing each independently.

Performance

Consistency — 400 mg/mL and above, enabling subcutaneous delivery of high-dose biologics
Stability — Stable at 2–8°C, bioactivity fully retained
Injectability — Dose delivered in under 20 seconds via standard drug delivery devices

Formulation advantages

No agglomeration — consistent physical behavior across molecules
Compatible with standard pre-filled syringes and autoinjectors

Why our approach is different.

Traditional challenge

Lindy's solution

Protein Damage

Ambient Temperature Process

Inconsistent Particle Behavior

Predictable, Repeatable Performance

Manufacturing Challenges

Established Pathway to Scale

Most attempts at high-concentration biologic suspensions face the same tradeoffs: processing conditions that damage the protein, inconsistent particle behavior, or manufacturing that can't scale.

Our suspension platform solves all three.

The microglassification process operates at ambient temperature. No heat. No freezing. No mechanical stress on the protein. The result is a particle that stays stable for years and flows through a standard 27G thin wall needle in under 20 seconds.

We've been here from the beginning. And our platform is licensed by a global top-5 pharmaceutical company.

Consistent. Stable. Injectable.

Across multiple molecules and formulations, Lindy's suspension platform has demonstrated consistent particle performance, long-term stability, and successful in vivo delivery.

Consistent

Reproducible size distributions across multiple formulations
Particles behave as inert hard spheres, consistent across molecules
No agglomeration when formulated into suspension

Stable

Long-term performance designed for real-world use
Stable at 2–8°C for >3 years
Stable at 25°C for >6 months
Bioactivity fully retained over time

Injectable

High-concentration delivery through standard devices
Dose delivered in under 20 seconds
Standard 27G thin-wall needle

Our platform. Your molecule.

Lindy Biosciences' proprietary suspension platform is designed to support high-dose biologics across a range of therapeutic areas and development strategies. Potential applications include:

New Molecular Entities

Enable SC delivery strategies earlier in development.

High-Dose IV Biologics

Explore pathways beyond infusion.

Lifecycle Management

Differentiate existing assets.

Biosimilars & Biobetters

Create new opportunities in competitive markets.

Emerging Applications

Additional opportunities under evaluation.

From platform to product.

Establishing a scalable manufacturing pathway is critical to translating platform innovation into clinical and commercial reality. We have partnered with Lifecore Biomedical (Nasdaq: LFCR), a fully integrated CDMO with more than 40 years of sterile injectable expertise, to support GMP manufacturing capability for clinical trials and commercial scale-up.

“

When deciding to select Lifecore for this important work, we were particularly drawn to the company’s creativity and willingness to collaborate.

Deborah Bitterfield, PhD, CEO & Founder, Lindy BiosciencesLifecore press release, October 2024

→ Read the Lifecore announcement

Bring More Biologics Beyond the Infusion Center

We partner with pharmaceutical companies to evaluate, develop, and license Lindy's suspension platform across high-dose biologic programs.

Partner with Us