Abstract: A protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.

Abstract: A biotherapeutic ophthalmic solution that may include a silk-derived protein as an active ingredient. Ophthalmic formulations are critical to the delivery of dosage forms, user requirements, and maintaining product stability. The formulations described herein are ophthalmic solutions that are comfortable to the user while product stability is maintained, even after long-term storage. Numerous excipients, manufacturing processes, and container closures were evaluated for their ability to stabilize silk-derived protein under ambient and accelerated conditions. Analyses showed that a small sub-set of protein-containing formulations meet the high physiochemical property standards required for therapeutic ophthalmic solutions.

Abstract: The invention provides a protein composition derived from silk fibroin, which composition possesses enhanced solubility and stability in aqueous solutions. The primary amino acid sequence of native fibroin is modified in the SDP such that cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains are reduced or eliminated. Additionally, the composition can have a serine content that is reduced by greater than 40% compared to native fibroin protein, and the average molecular weight of the SDP is less than about 100 kDa.