Last Updated: July 6, 2026

Claims for Patent: 9,175,068

✉ Email this page to a colleague

« Back to Dashboard

Summary for Patent: 9,175,068

Title:	Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use
Abstract:	The present invention relates to a new and improved method for preparing a highly concentrated immunoglobulin composition from pooled plasma for subcutaneous injection. A composition comprising 20% or more immunoglobulin suitable for subcutaneous use is also described.
Inventor(s):	Teschner; Wolfgang (Vienna, AT), Butterweck; Harald Arno (Vienna, AT), Pljevljakovic; Azra (Vienna, AT), Bauer; Theresa Friederike (Vienna, AT), Koelbl; Bernhard (Achau, AT), Schwarz; Hans-Peter (Vienna, AT), Nikolic; Nebojsa (Vienna, AT), Poelsler; Gerhard (Vienna, AT), Kindermann; Johanna (Maria Enzersdorf, AT)
Assignee:	Baxalta Incorporated (Bannockburn, IL) Baxalta GmbH (Glattpark (Opfikon), CH)
Application Number:	13/949,565
Patent Claims:	1. A method for preparing a concentrated immunoglobulin G (IgG) composition, comprising the steps: (A) concentrating a first solution comprising IgG to a protein concentration of from 2% to 10% (w/v) by ultrafiltration using a first ultra-/diafiltration system comprising a first ultrafiltration membrane having a nominal molecular weight cut off (NMWCO) of 100 kDa or less, thereby forming a first IgG concentrate, wherein at least 95% of protein in the first solution is IgG; (B) diafiltering the first IgG concentrate against a diafiltration buffer using the first ultra-/diafiltration system comprising the first ultrafiltration membrane, thereby forming a first IgG diafiltrate; (C) concentrating the first IgG diafiltrate to a protein concentration of greater than 20% (w/v) by ultrafiltration using the first ultra-/diafiltration system comprising the first ultrafiltration membrane, thereby forming a second IgG concentrate; (D) collecting the second IgG concentrate from the first ultra-/diafiltration system; (E) washing the first ultrafiltration membrane by re-circulating a post-wash buffer through the first ultra-/diafiltration system wherein the first ultra-/diafiltration system is washed with a volume of post-wash buffer equal to at least two times the dead volume of the first ultra-/diafiltration system, thereby forming a first IgG post-wash solution; (F) transferring the first IgG post-wash solution from the first ultra-/diafiltration system into a second ultra-/diafiltration system comprising a second ultrafiltration membrane having a nominal molecular weight cut off (NMWCO) of 100 kDa or less, wherein the surface area of the second ultrafiltration membrane is lower than the surface area of the first ultrafiltration membrane; (G) concentrating the first IgG post-wash solution to a protein concentration of greater than 20% (w/v) by ultrafiltration using the second ultra-/diafiltration system comprising a second ultra-/diafiltration membrane, thereby forming a third IgG concentrate; and (H) combining the third IgG concentrate from the second ultra-/diafiltration system with the second IgG concentrate, thereby forming a concentrated IgG composition. 2. The method of claim 1, wherein the first and second ultrafiltration membranes have a nominal molecular weight cut off (NMWCO) of 80 kDa or less. 3. The method of claim 1, wherein the first and second ultrafiltration membranes have a nominal molecular weight cut off (NMWCO) of 60 kDa or less. 4. The method of claim 1, wherein the first and second ultrafiltration membranes have a nominal molecular weight cut off (NMWCO) of 50 kDa or less. 5. The method of claim 1, wherein the first and second ultrafiltration membranes have a same nominal molecular weight cut off (NMWCO). 6. The method of claim 2, wherein the first and second ultrafiltration membranes have a same nominal molecular weight cut off (NMWCO). 7. The method of claim 3, wherein the first and second ultrafiltration membranes have a same nominal molecular weight cut off (NMWCO). 8. The method of claim 4, wherein the first and second ultrafiltration membranes have a same nominal molecular weight cut off (NMWCO). 9. The method of claim 1, wherein the surface area of the second ultrafiltration membrane is no more than a tenth of the surface area of the first ultrafiltration membrane. 10. The method of claim 2, wherein the surface area of the second ultrafiltration membrane is no more than a tenth of the surface area of the first ultrafiltration membrane. 11. The method of claim 3, wherein the surface area of the second ultrafiltration membrane is no more than a tenth of the surface area of the first ultrafiltration membrane. 12. The method of claim 4, wherein the surface area of the second ultrafiltration membrane is no more than a tenth of the surface area of the first ultrafiltration membrane. 13. The method of claim 1, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 14. The method of claim 2, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 15. The method of claim 3, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 16. The method of claim 4, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 17. The method of claim 5, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 18. The method of claim 6, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 19. The method of claim 7, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 20. The method of claim 8, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 21. The method of claim 9, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 22. The method of claim 10, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 23. The method of claim 11, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H). 24. The method of claim 12, further comprising the steps of: (I) washing the second ultrafiltration membrane by re-circulating a post-wash buffer through the second ultra-/diafiltration system, thereby forming a second IgG post-wash solution; and (J) combining the second IgG post-wash solution from the second ultra-/diafiltration system with the concentrated IgG composition formed in (H).

Details for Patent 9,175,068

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	April 27, 2005	9,175,068	2033-07-24
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	December 12, 2018	9,175,068	2033-07-24
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 9,175,068

Subscribe to access the full database, or Start Trial
Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010138736	⤷ Start Trial
United States of America	8546548	⤷ Start Trial
United States of America	2022153823	⤷ Start Trial
United States of America	2019085064	⤷ Start Trial
United States of America	2016244512	⤷ Start Trial
United States of America	2014030252	⤷ Start Trial
United States of America	2010330071	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.