MANAGEMENT: Deborah Bitterfield
DUKE INVENTOR: David Needham

Lindy Biosciences is a development-stage protein therapeutic formulations company. Our core technology produces spherical, dense, stable particles of a therapeutic protein. These protein particles are ideal for long-term storage, or for non-standard formulations such as suspension formulations (for high-concentration delivery of antibodies), encapsulation (for sustained/controlled release), or dry powder pulmonary delivery.​

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Produces dense, dry, stable protein particles ideal for suspensions or encapsulation

Microglassification™ is a process that gently removes a majority of the water from solutions of proteins, or other biologics, resulting in solid, spherical, amorphous microbeads. In this dry state, biologics are often stable enough for long-term storage, transport, or incorporation into drug delivery formulations.

The video shows one of our early experiments: Microglassification™ of a single protein microdroplet, held on the end of a glass capillary micropipette. The resulting solid microbead consists of pure protein at > 1 g/mL. Currently used methods mimic this experiment, producing protein microdroplets on a bulk scale and dehydrating those microdroplets within seconds.

High-Concentration Biologics

Biological molecules such as monoclonal antibodies often require dosing of several hundred mg. In order to allow subcutaneous administration, which can only accomodate 1-2 mL of volume, the protein must be formulated at high concentration (>200 mg/mL). However, the viscosity of solutions of these molecules increases dramatically above 100 mg/mL, making injection prohibitively difficult.

Suspensions of Microglassified protein can have a much lower viscosity than solutions of the same concentration. Preliminary formulations have been injectable through a 27G needle at >500 mg/mL.