US 11,873,332 B2
Lyophilized formulation of a monoclonal antibody against transthyretin
Joseph Alexander Soto, San Francisco, CA (US); Andrea Hawe, Munich (DE); Ruedeeporn Tantipolphan, Munich (DE); and Stefan Heindl, Perchtoldsdorf (AT)
Assigned to NOVO NORDISK A/S, Bagsvaerd (DK)
Appl. No. 16/767,994
Filed by Novo Nordisk A/S, Bagsvaerd (DK)
PCT Filed Nov. 28, 2018, PCT No. PCT/US2018/062902
§ 371(c)(1), (2) Date May 28, 2020,
PCT Pub. No. WO2019/108689, PCT Pub. Date Jun. 6, 2019.
Claims priority of provisional application 62/592,294, filed on Nov. 29, 2017.
Prior Publication US 2020/0362023 A1, Nov. 19, 2020
Int. Cl. A61K 39/395 (2006.01); C07K 16/18 (2006.01); A61K 9/19 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/18 (2013.01) [A61K 9/19 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61K 9/0019 (2013.01); A61K 45/06 (2013.01); A61K 2039/545 (2013.01); C07K 2317/24 (2013.01); C07K 2317/56 (2013.01)] 12 Claims
 
1. A pharmaceutical formulation comprising:
(a) a monoclonal antibody comprising a mature heavy chain comprising the amino acid sequence of SEQ ID NO:82 except the C-terminal lysine may be absent and a mature light chain comprising the amino acid sequence of SEQ ID NO:86, wherein the antibody is present at a concentration within the range from about 25 mg/mL to about 75 mg/mL;
(b) a histidine buffer present at a concentration of about 20 mM;
(c) sucrose present at a concentration of about 220 to about 260 mM, and
(d) poloxamer 188 (PX188) present at a concentration within the range from about 0.03% to about 0.050% by weight;
wherein the formulation is characterized by a pH within the range from about 5.5 to about 6.5.