Claims for Patent: 10,478,498

Summary for Patent: 10,478,498

Title:	Excipient compounds for biopolymer formulations
Abstract:	The invention encompasses formulations and methods for the production thereof that permit the delivery of concentrated protein solutions. The inventive methods can yield a lower viscosity liquid protein formulation or a higher concentration of therapeutic or nontherapeutic proteins in the liquid formulation, as compared to traditional protein solutions. The inventive methods can also yield a higher stability of a liquid protein formulation.
Inventor(s):	Soane; David S. (Palm Beach, FL), Wuthrich; Philip (Watertown, MA), Casado Portilla; Rosa (Middleton, MA), Mahoney; Robert P. (Newbury, MA), Moody; Mark (Concord, MA), Greene; Daniel G. (Belmont, MA)
Assignee:	REFORM BIOLOGICS, LLC (Woburn, MA)
Application Number:	15/331,197
Patent Claims:	1. An injectable, liquid pharmaceutical formulation comprising at least about 100 mg/ml therapeutic protein and a viscosity-reducing amount of caffeine, wherein the viscosity-reducing amount of caffeine is about 15 mg/ml or less, and wherein the formulation further comprises niacinamide, and wherein the viscosity of the formulation is at least about 30% less than the viscosity of a control formulation, wherein the control formulation does not contain caffeine but is otherwise identical on a dry weight basis to the liquid pharmaceutical formulation. 2. The formulation of claim 1, wherein the therapeutic protein is an antibody. 3. The formulation of claim 1, wherein the therapeutic protein is selected from the group consisting of bevacizumab, trastuzumab, adalimumab, infliximab, etanercept, darbepoetin alfa, epoetin alfa, cetuximab, pegfilgrastim, filgrastim, and rituximab. 4. The formulation of claim 1, wherein the viscosity of the formulation is at least about 50% less than the viscosity of the control formulation. 5. The formulation of claim 1, wherein the viscosity is less than about 20 cP. 6. The formulation of claim 5, wherein the viscosity is less than about 10 cP. 7. The formulation of claim 1, wherein the formulation contains at least about 200 mg/mL of the therapeutic protein. 8. The formulation of claim 1, wherein the viscosity-reducing amount of caffeine is about 15 mg/ml. 9. The formulation of claim 8, wherein the amount of niacinamide is about 15 mg/ml. 10. The formulation of claim 7, wherein the therapeutic protein is an antibody.

Details for Patent 10,478,498

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	06/01/1989		2034-06-20
Amgen, Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234			2034-06-20
Amgen, Inc.	PROCRIT	epoetin alfa	Injection	103234			2034-06-20