24.05.16 () 13:00

Dailypharm

X
'23 13 ' ..., ù
õ 2023-12-18 12:03:24
'23 13 ' ..., ù
õ 2023-12-18 12:03:24

, ˸۷ FDA 㰡...2 㰡 ҹ߿ ̱

4 â GMP ǻ Ϸ...7 㰡 û 5 㰡

ö ǥ, ˸۷ ̱ ...R&D
  .

[ϸ=õ ] ڰ ʷ ̱ ߴ. 2010 ̱ õ 13 2 㰡 ҹ 縦 㰡 ߴ. ڴ 13 Ը . ö ǥ (R&D) ҽ ξٴ 򰡰 ´.

ڴ 15 ̱ ǰǾ౹(FDA)κ ˸۷(ALYGLO) ǰ 㰡 ȹߴٰ 18 .

ڴ 4 â ü ǻ縦 ޾Ұ ̸ 7 㰡û(BLA) ߴ. 㰡 û 5 뺸 ޾Ҵ.

ڴ 2020 Ϸ Ϲ ӻ 3󿡼 FDA ̵ο ȿ Ų ִ. ӻ 3迡 鿪 ִ ȯ 48 ˸۷θ 12 ȿ Ȯߴ.

  Ǹ ̺۷κҸ.
˸۷δ ȹκ ׻ 鿪۷κҸ. õ 鿪, 鿪 ǰ 1 鿪 ȯ ġῡ ȴ. '̺۷κҸ' ǰ Ǹ ̴. ̱ 鿪۷κҸ 104 ޷( 13) Ը ߻ȴ. αȭ ڰ鿪ȯ ̱ 鿪۷κҸ 䰡 ϴ ߼.

ڴ FDA 㰡 û 3° õ ̱ ߴ.

ڴ 2015 FDA 鿪۷κҸ(IVIG-SN) 5% ǰ 㰡 ûߴ. 2016 FDA 㰡 2016 11 FDAκ ڷ ޾Ҵ. ڴ 2017 9 ٽ ڷᰡ ߰ û 㰡 ƴ.

ڴ 5% ǰ ̱ 忡 ӻ 10% ǰ ȹ̾. 5% ǰ 㰡 强 ū 10% ǰ ̱ 忡 ߴ.

ڴ 2020 IVIG-SN10% ˸۷ Ϲ ӻ 3 ϰ 2021 2 FDA ǰ㰡 û ߴ. ۳ 2 FDAκ ǰ㰡 뺸 ޾Ҵ. ڷγ19 Ȳ 򰡸 2021 4б⿡ ߴµ, FDA ü ǻ簡 ʿϴٴ 㰡 ⸦ ߴ.

FDA ǻ 4 17Ϻ 28ϱ â IVIG-SN ȹ, ü, ü ǰý ǻ縦 ߴ. ڴ â GMP ǻ縦 Ϸ FDA Ǹ 㰡û ٽ ߴ.

ȸ FDA óǾǰ û 1 13ϱ ߴ Ѻ 1 ҽ Դ١ ߴ. ˸۷δ â忡 ϰ ǸŴ ̱ ȸ GC ̿ĸ USA ̷ ̴.

  â.

̱ Կ ̹ ó̴. Ը ڿ ȭ ʼ ڰ ſ ̱ ߻ϴ ˷.

ڴ 鿪۷κҸ 'CEX ũθ׷(Cation Exchange Chromatography, ̿ ȯ м)' ν ǰ شȭߴ. ߻ ֿ Ǵ (FXIa) Ҽ ϴµ Ѵ. ̴ м(Frontiers in Cardiovascular Medicine) ƴ.

˸۷ ̱ ö ǥ̻簡 ߴ. ǥ ˸۷ 㰡ҹ߰ Ϲ Ű Ŀ ̱ 㰡 ѷ . ǥ â ä ȸ 㿵 ȸ ̴. 2014 ǥ̻縦 ̴.

鿪۷κҸ ٽ ̴. 4204 ȸ ü 23.7% ߴ.

ڴ 2010 ̱ ߴ. ڴ 2010 ASDコɾ 3 48000 ޷ Ը ̺۷κҸ 캴ġ ׸ üߴ. ׷ ӻ Ⱓ ȹ 2015 9 ASDコɾ ذ ƴ.

ڴ 캴ġ ̱ ȹ ִ. 2016 10 GCڴ ̱ ӻ 3 A 캴 ġ ׸ ̱ ӻ ߴŰ ߴ. 2012 ӻ3迡 4 ⸦ ߴ. ̱ ӻ ߴ ϡ ƴ.

ȯ Ư ű ȯ ӻ 󺸴 ٰ, ȿ ӽð ๰ ̱ ӻ ϷǴ Ȯ ִٴ Ǵܿ ̱ ȸ ̷.

̱ ƴ. ڴ Ϲ ߴ.

Ȧ 2017 21000 ij ޷( 1870) 鿩 ij Ʈÿ ذߴ. 63000 Ǽ ִ 100 ȹ ̺۷κҸ, ˺ι ϴ .

˸۷ ̱ 㰡 󺸴 Ǹ鼭 Ϲ̹ ûߴ. Ȧ(GC) 2020 7 Ϲ 迭 2 ִ ȸ ׸(Grifols) 46000 ޷ Űߴ. GC Ϲ GCNA(Green Cross North America) ȸ GCBT(Green Cross BioTherapeutics) 1891 Űϸ鼭 ٸ ̱ GCAM(Green Cross America) ѱ ̴.

GCBT GC ijٿ Ǽ ׺ȹ ̴. GCAM ̱ ϴ ̴. GCAM Ȯ GCBT ϴ ȭ ȮǼ ߴ.

ij GCBT ڴ Ϸ ̿ η 2018 κ η¡ ޾ƿԴ. ̷ Ȳ ׸ μ Ÿϸ鼭 Ű ̷. ڴ GCBT GCAM κ ȸ .

ö ǥ̻ ̹ ̱ 鿪 ȯڵ鿡 ϰ ȿ ġ ɼ ְ ڴ١ ׵ ȯ ȯڵ ŭ, Ȯ ȯڿ Ƿ 鿡 ġ ȯ ϱ ּ ̶͡ ߴ.
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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 05)
౹ 71
ǰ ְ
ѽŻ÷(10) 3,500 2,300 1,200 3,028
޾(100) 25,000 22,000 3,000 23,304
Ʒγΰ(100) 30,000 27,000 3,000 29,237
īɾ(10g) 8,000 5,500 2,500 6,472
Ľõ򿬰(5g) 5,500 4,000 1,500 5,035
Ź(4) 5,000 3,500 1,500 4,449
ڶ(20) 7,000 5,800 1,200 6,433
(10) 6,000 4,000 2,000 4,914
Ժ(10) 4,000 3,000 1,000 3,543
ڱ׸(20) 5,000 3,800 1,200 4,622
ť(10) 3,500 2,300 1,200 2,828
Ȱť(1) 1,200 1,000 200 1,140
Ǯɾ(3.3ml) 25,000 22,000 3,000 24,214
޵𿬰(10g) 7,000 5,000 2,000 6,162
öŸ(34) 13,000 10,000 3,000 12,089
뽺ī(20g) 22,000 18,000 4,000 20,358
ġ(1) 1,100 1,000 100 1,000
ӽ÷(21) 10,000 7,500 2,500 8,998
ͺ(10) 3,500 2,300 1,200 3,138
ݿ(1ڽ) 3,000 2,500 500 2,947
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,973
߽Ÿ(120) 70,000 40,000 30,000 54,203
Źĸ(10ĸ) 3,000 2,000 1,000 2,941
Ÿ̾(120) 60,000 40,000 20,000 49,168
տ(60ĸ) 30,000 24,000 6,000 27,235
Ÿ̷ER(6) 2,500 2,500 0 2,500
ٿ(30g) 12,000 9,000 3,000 11,221
(120) 25,000 18,000 7,000 21,716
Ʒ(6) 4,000 3,000 1,000 3,509
ǽõĸ(270ĸ) 120,000 85,000 35,000 106,875
B(120) 70,000 60,000 10,000 62,308
׳(10) 3,000 2,000 1,000 2,684
6̺(10) 3,500 2,000 1,500 2,965
(60) 250,000 200,000 50,000 224,000
Ⱦ 12,000 9,000 3,000 10,494
̰źĸ(60ĸ) 25,500 22,000 3,500 23,942
Ųť(20) 5,500 4,500 1,000 4,823
λ絹÷(100) 37,000 29,000 8,000 31,878
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