7-7-7: Low Endotoxin & Low Aggregate Antibody Production

777 Service Details:

Service Item

Deliverables

Duration

QC

Gene synthesis, cloning and plasmid prep all included

20 mL CHO/HEK293 500 mL CHO/HEK293

3-10 mg, average 4.5 mg after 2-step purification 100-500 mg

3 weeks

A280, Caliper (R/NR) or SDS-PAGE (R/NR), SEC-HPLC, and endotoxin (<0.5 EU/mg) SEC-HPLC 7.922

1.dx

100 150 200 250 300 350 400

3 weeks

Additional QC

RP-HPLC, bioburden, DSF, DSC, SPR, LC/MS, SEC-MALS, peptide mapping, glycan profiling, cIEF, CHO HCP, residual DNA, ELISA, Western blot, freeze thaw study, micro-developability testing

6.911

50

0

0.5 1 1.5 2 2.5 3 3.5

44.555.566.5 7

7.5 8 8.5 9 9.5 10 10.5 11 11.5 12 12.5 13 13.5 14 14.5 15

Time (min)

Signal:

DAD1A, Sig=280,4 Ref=o

Name RT (min) 6.911 7.922

Width (min) 0.40 0.33 Sum

Area 23.50

Height 0.79 389.44

Area% 0.28 99.72

Case Study: High-Purity mAb Production Confirmed by SEC-HPLC and Caliper-SDS Data

8365.79 8389.29

In this case, the purity of vanilla antibodies produced in 777 platform showed high purity.

Caliper-SDS

SEC-HPLC

1.dx

Caliper-SDS NR

7.922

100 150 200 250 300 350 400

[Labchip_2021-11-09_18-24-41/A3] 1 NR

99.41

LM % Purity Type

1000 1200

0 200 400 600 800

Xsys

0.59

Xsys

x

6.911

50

0

15

20

25

30

35

40

0.5 1 1.5 2 2.5 3 3.5

44.555.566.5 7

7.5 8 8.5 9 9.5 10 10.5 11 11.5 12 12.5 13 13.5 14 14.5 15

Aligned Time (sec)

Time (min)

Signal:

DAD1A, Sig=280,4 Ref=o

Caliper-SDS R

Name RT (min) 6.911 7.922

Width (min) 0.40 0.33 Sum

Area 23.50

Height 0.79 389.44

Area% 0.28 99.72

[Labchip_2021-11-09_18-24-41/E3] 1 Reduce

68.06

% Purity Type

8365.79 8389.29

1000 1200 1400 1600

31.94

LM

400 600 800

Xsys

Caliper-SDS

0 200 -200

Caliper-SDS NR

15

20

25

30

35

40

[Labchip_2021-11-09_18-24-41/A3] 1 NR

Aligned Time (sec)

99.41

LM % Purity Type

1000 1200

0 200 400 600 800

Xsys

0.59

Xsys

x

15

20

25

30

35

40

Aligned Time (sec)

Caliper-SDS R

[Labchip_2021-11-09_18-24-41/E3] 1 Reduce

68.06

% Purity Type

1000 1200 1400 1600

31.94

LM

Learn more: Protein Sciences: HTP Production of High-Quality Vanilla Antibodies

About WuXi Biologics

400 600 800

Xsys

WuXi Biologics is a leading contract research, development and manufacturing organization (CRDMO) that provides end-to-end capabilities to healthcare organizations worldwide. With operations in China, the United States, Ireland, Germany, and Singapore, we enable our partners to effectively and efficiently bring biologics and vaccines to patients worldwide through our comprehensive and high-quality drug development model. 15 20 25 30 35 40 Aligned Time (sec) 0 200 -200

The world’s leading global single-source platform from concept to commercialization.

wuxibiologics.com | info@wuxibiologics.com

5-9-2024

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