IP Library Granted Patent US 12,577,540
Granted Patent B2
US 12,577,540 · App. 18/255,221 · Granted Mar 17, 2026

Suspension mode seed train development for adherent cells

Inventor: Maroof Alam (Cambridge, MA)
Assignee: Sarepta Therapeutics, Inc.
C12N7/00C12N5/0686C12N15/86C12N2500/90C12N2750/14143C12N2750/14152
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Quick Facts
Patent No.
US 12,577,540
App. No.
18/255,221
Granted
Mar 17, 2026
Kind
B2
Abstract

The disclosure is directed to a method for seed train expansion of adherent cells comprising culturing cells with a serum-supplemented growth medium in a N-2 vessel; removing the cells from the serum-supplemented medium; inoculating the cells from step into a serum-free growth medium in a N-1 vessel; culturing the cells in the N-1 vessel under suspension conditions; and inoculating a growth medium in a bioreactor with the suspension-cultured cells. In some aspects, the adherent cells are not suspension-adapted. In some aspects, the adherent cells are suspension-adapted. In some aspects, the adherent cells produced by the seed train expansion method are used to produce viral vectors. In some aspects, the viral vectors are AAV vectors.

Claims (65)

1 . A method of cell expansion of adherent mammalian cells comprising:

(a) culturing the adherent mammalian cells under adherent conditions with a first growth medium comprising serum in a N-2 container;

(b) removing the adherent mammalian cells from the first growth medium;

(c) inoculating the adherent mammalian cells from step (b) into a second growth medium comprising no serum or serum at a concentration less than the first growth medium in a N-1 container;

(d) culturing the adherent mammalian cells in the N-1 container under suspension conditions in the second growth medium;

(e) collecting the adherent mammalian cells or the adherent mammalian cells in the second growth medium from step (d) from the N-1 container;

(f) passaging the adherent mammalian cells from step (d) at least one time under suspension conditions in the second growth medium;

(g) inoculating the adherent mammalian cells or the adherent mammalian cells in the second growth medium with a third growth medium in a bioreactor; and

(h) culturing the adherent mammalian cells in the bioreactor.

2 . The method of claim 1 , wherein the third growth medium comprises a higher serum concentration than the serum concentration in the second growth medium.

3 . The method of claim 1 , wherein the adherent mammalian cells are Hela cells, CHO cells, HEK-293 cells, VERO cells, BHK cells, MDCK cells, MDBK cells, or COS cells.

4 . The method of claim 1 , further comprising culturing the adherent mammalian cells with the first growth medium in a N-3 container.

5 . The method of claim 4 , further comprising culturing the adherent mammalian cells with the first growth medium in a N-4 container.

6 . The method of claim 5 , further comprising culturing the adherent mammalian cells with the first growth medium in a N-5 container.

7 . The method of claim 1 , wherein the third growth medium in the bioreactor comprises at least one factor which promotes cell adherence.

8 . The method of claim 7 , wherein the at least one factor which promotes cell adherence is serum, FBS, fibronectin, collagen, laminin, calcium ions, proteoglycans or non-proteoglycan polysaccharides of the extracellular matrix, or combinations thereof.

9 . The method of claim 8 , wherein the third growth medium in the bioreactor comprises DMEM and 10% FBS.

10 . The method of claim 1 , further comprising contacting the adherent mammalian cells with a first polynucleotide sequence in the bioreactor.

11 . The method of claim 10 , wherein the first polynucleotide sequence is a plasmid.

12 . The method of claim 10 , further comprising contacting the adherent mammalian cells with a second polynucleotide encoding a transgene.

13 . The method of claim 12 , further comprising contacting the adherent mammalian cells with a third polynucleotide that encodes an adenoviral helper gene.

14 . A method of cell expansion of adherent mammalian cells comprising:

(a) culturing the adherent mammalian cells under adherent conditions with a first growth medium comprising serum in a N-3 container;

(b) removing the adherent mammalian cells from the first growth medium;

(c) inoculating the adherent mammalian cells from step (b) into a second growth medium comprising no serum or serum at a concentration less than the first growth medium in a N-2 container;

(d) culturing the adherent mammalian cells in the N-2 container under suspension conditions in the second growth medium;

(e) collecting the adherent mammalian cells or the adherent mammalian cells in the second growth medium from step (d) from the N-2 container;

(f) inoculating the adherent mammalian cells or the adherent mammalian cells in the second growth medium into the second growth medium in a N-1 container;

(g) culturing the adherent mammalian cells in the N-1 container under suspension conditions in the second growth medium;

(h) collecting the adherent mammalian cells or the adherent mammalian cells in the second growth medium from step (g) from the N-1 container;

(i) inoculating the adherent mammalian cells or the adherent mammalian cells in the second growth medium with a third growth medium in a bioreactor; and

(j) culturing the adherent mammalian cells in the bioreactor.

15 . The method of claim 14 , further comprising culturing the adherent mammalian cells with the first growth medium in a N-4 container.

16 . The method of claim 15 , further comprising culturing the adherent mammalian cells with the first growth medium in a N-5 container.

17 . A method of seed-train expansion of adherent mammalian cells comprising:

(a) culturing the adherent mammalian cells under adherent conditions in a first growth medium comprising serum;

(b) removing the adherent mammalian cells from the first growth medium;

(c) suspending the adherent mammalian cells in a second growth medium comprising no serum or serum at a concentration less than the first growth medium;

(d) culturing the adherent mammalian cells from step (c) under suspension conditions in the second growth medium;

(e) passaging the adherent mammalian cells from step (d) at least one time under suspension conditions in the second growth medium;

(f) inoculating the adherent mammalian cells or the adherent mammalian cells in the second growth medium with a third growth medium in a bioreactor; and

(g) culturing the adherent mammalian cells in the bioreactor.

18 . The method of claim 17 , wherein the adherent mammalian cells of step (a) are passaged at least once under adherent conditions.

19 . The method of claim 17 , wherein the adherent mammalian cells are passaged no more than two times under suspension conditions.

20 . A method of producing a viral particle, comprising:

(a) culturing adherent mammalian cells under adherent conditions in a first growth medium comprising serum;

(b) removing the adherent mammalian cells from the first growth medium;

(c) suspending the adherent mammalian cells in a second growth medium comprising no serum or serum at a concentration less than the first growth medium;

(d) culturing the adherent mammalian cells from step (c) under suspension conditions in the second growth medium;

(e) passaging the adherent mammalian cells from step (d) at least one time under suspension conditions in the second growth medium;

(f) inoculating the adherent mammalian cells or the adherent mammalian cells in the second growth medium with a third growth medium in a bioreactor;

(g) transfecting the adherent mammalian cells with a polynucleotide sequence encoding a viral capsid protein; and

(h) culturing the adherent mammalian cells in the bioreactor under conditions in which the viral particle is produced.

21 . The method of claim 20 , further comprising isolating the viral particle produced in step (h).

22 . The method of claim 20 , wherein the adherent mammalian cells of step (a) are passaged at least once under adherent conditions.

23 . The method of claim 20 , wherein the adherent mammalian cells of step (e) are passaged at least two, at least three, at least four, or at least five times under suspension conditions.

24 . The method of claim 11 , wherein the plasmid encodes a capsid protein of a recombinant AAV particle.

25 . The method of claim 24 , wherein the adherent mammalian cells are cultured under conditions which produce the recombinant AAV particle.

26 . The method of claim 1 , wherein the adherent mammalian cells of step (f) are passaged at least two times under suspension conditions before being inoculated in the bioreactor.

27 . The method of claim 14 , wherein the adherent mammalian cells of step (g) are passaged at least one time under suspension conditions before being inoculated in the bioreactor.

28 . The method of claim 17 , wherein the adherent mammalian cells of step (e) are passaged at least two times under suspension conditions before being inoculated in the bioreactor.

29 . The method claim 1 , wherein the bioreactor is an adherent bioreactor.

30 . The method of claim 14 , wherein the bioreactor is an adherent bioreactor.

31 . The method of claim 17 , wherein the bioreactor is an adherent bioreactor.

32 . The method of claim 20 , wherein the bioreactor is an adherent bioreactor.

Assignments (2)
SECURITY INTEREST Recorded May 7, 2025
From: SAREPTA THERAPEUTICS, INC.
To: JPMORGAN CHASE BANK, N.A. AS ADMINISTRATIVE AGENT
Reel/Frame 071218/0445 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 9, 2024
From: ALAM, MAROOF
To: SAREPTA THERAPEUTICS, INC.
Reel/Frame 068233/0074 →
Continuity (2)
Provisional Application 63123602 · Dec 10, 2020
Related Publication 20240018487A1 · Jan 18, 2024
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