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.
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.
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.