US 12,274,750 B2
Lyophilized formulation of long-acting human growth hormone immunoglobulin conjugate
Hwa Peoung Rim, Seoul (KR); Hyun Uk Kim, Busan (KR); Ho Taek Im, Yongin-si (KR); Sang Yun Kim, Gimpo-si (KR); Hyung Kyu Lim, Hwaseong-si (KR); Sung Min Bae, Seongnam-si (KR); and Se Chang Kwon, Seoul (KR)
Assigned to HANMI PHARM. CO., LTD., Hwaseong-si (KR)
Filed by HANMI PHARM. CO., LTD., Hwaseong-si (KR)
Filed on Dec. 28, 2020, as Appl. No. 17/135,468.
Application 17/135,468 is a division of application No. 15/025,127, granted, now 10,987,425, previously published as PCT/KR2014/009059, filed on Sep. 26, 2014.
Claims priority of application No. 10-2013-0115177 (KR), filed on Sep. 27, 2013.
Prior Publication US 2021/0138070 A1, May 13, 2021
Int. Cl. C07K 14/61 (2006.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); A61K 38/27 (2006.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 47/68 (2017.01)
CPC A61K 47/26 (2013.01) [A61K 9/0019 (2013.01); A61K 9/19 (2013.01); A61K 38/27 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01); A61K 47/68 (2017.08); A61K 47/6811 (2017.08); A61K 47/6883 (2017.08)] 7 Claims
 
1. A lyophilized formulation of a long-acting human growth hormone conjugate, said lyophilized formulation being obtainable or being obtained from an aqueous solution comprising a long-acting human growth hormone (hGH) conjugate in which a physiologically active hGH is linked to an immunoglobulin Fc region via polyethylene glycol having aldehyde groups at both ends and an albumin-free solution comprising a buffer, polysorbate 80 as a non-ionic surfactant, and mannitol as a sugar alcohol,
wherein the mannitol is included at a concentration ranging from 4% (w/v) to 4.5% (w/v) based on a total volume of the aqueous solution;
wherein the buffer is citrate or acetate buffer comprising 20 mM of sodium citrate or sodium acetate, and a pH of the buffer ranges from 5.2 to 5.6;
wherein a concentration of the long-acting hGH conjugate ranges from 58.5 to 78 mg/ml of the aqueous solution;
wherein the polysorbate 80 is included at a concentration of 0.005% (w/v) based on the total volume of the aqueous solution; and
wherein the immunoglobulin Fc region is a human IgG4-derived aglycosylated Fc region.