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Cell Line Development New

Accelerate Biologics with Speed, Precision, and Confidence

At Aragen Bioscience, we know what it takes to move your biologic from idea to IND—and we’re here to help you get there faster. With nearly 30 years of expertise in biologics and biosimilars, our cell line development (CLD) services are designed to help you overcome complex R&D challenges, reduce risk, and shorten timelines—without compromising on quality.

Built Around Your Biologics Journey

Whether you are developing a novel therapeutic or advancing a biosimilar, our solutions are designed with your goals in mind. From host cell line selection to IND-ready packages, we support every stage of your development.

When you choose Aragen, you are partnering with a leader that works as an extension of yours—focused on solving your biggest technical challenges while unlocking the full potential of your product.

What Sets Our CLD Services Apart?

We do not believe in one-size-fits-all. Our approach is flexible, efficient, and fully customized to your biopharmaceuticals, your timelines, and your success.

  • Broad Host Cell Line and Vector Capabilities : We are proficient in working with multiple host cell lines including CHO DG44, CHO GS, SP2/0, and NS0, and we support various expression systems such as DHFR, GS, and antibiotic resistance vectors—giving you the flexibility to choose the best-fit system for your therapeutic.
  • Deep Expertise Across Biologics : We have successfully expressed a wide range of proteins including human, mouse, canine, and feline IgGs, fusion proteins, enzymes, cytokines, hormones, mini-bodies, and bispecific antibodies—even complex or hard-to-express candidates.
  • RapTr2022: Fast-Track Platform for Complex Projects : Our RapTr2022 platform is built for speed and performance. Leveraging our proven CHO-DG44 and CHO-GS systems, it is ideal for clients needing to express difficult proteins or meet accelerated timelines.
  • Three Decades of Scientific Depth : We bring more than 30 years of expertise in engineered cell lines and biologics development—ensuring your product is built on a foundation of science and strategy.

Your Fast Track to IND: Seamless, Stable Cell Line Development

Bringing your biologic to market starts with a stable, high-yielding cell line. Our streamlined process is designed to move you efficiently from DNA to Research Cell Bank (RCB)—helping you file your IND with confidence.

With over 200 successful CLD projects and 100+ advancing to clinical phases, we have proven our ability to deliver high-quality results, fast.

Platform Overview: Scalable, Regulatory-Ready Solutions

Aragen Bioscience offers a full spectrum of cell line development services that ensure robust, scalable, and regulatory-compliant production.

CHO-DG44 Platform

Trusted for stability and high productivity—an ideal choice for biosimilar development.

  • Royalty-free and low-risk
  • >4g/L protein yield in ~18 weeks
  • IND-/BLA-ready data packages
  • Expertise in biosimilar development

CHO-GS Platform

Robust and versatile, built around a proprietary GS-expression vector.

  • Royalty-free, stable expression platform
  • Mini pools up to 4.2g/L | Bulk pools up to 700mg/L
  • Single cell clones (SCC) up to 6g/L in fed-batch flasks
  • 60+ days of stability in growth and productivity
  • Optimized from transfection to SCC in just 16 weeks

RapTr2022: The Express Lane to IND

If time is your top priority, RapTr2022 delivers.

  • Royalty-free, cost-efficient, and fast
  • Up to 6g/L protein expression
  • DNA transfection to Research Cell Bank (RCB) in just 18 weeks
  • Advanced imaging ensures clonality and consistency
  • Built for fast-track biologics and accelerated IND filings

CLD Workflow

Parallel Cell Line Development: Reduce Risk, Maximize Return

Choosing the right expression platform can be a make-or-break decision. We mitigate risk by offering parallel development—testing multiple platforms in tandem so you can identify the best-performing line early. Once a lead is confirmed, alternate tracks are paused, saving time and resources without delaying your IND.

Specialized Biosimilar Support

As the biosimilar market continues to grow, we help you capitalize on it. Our team is equipped to manage the scientific and regulatory complexity of biosimilar development with precision.

  • Structural Equivalence: Develop biosimilars that mirror innovator drugs in safety, structure, and efficacy
  • Process Optimization: Tailored solutions for scale-up and cost-effective production
  • Therapeutic Area Expertise: Inflammatory diseases, oncology, rare genetic disorders, and more

The Aragen Advantages

We’re more than a vendor—we’re a long-term partner invested in your product’s success.

  • 200+ successful CLD programs
  • 100+ IND-enabling projects
  • 5-month CLD timelines for faster market entry
  • Diverse platform offerings: CHO DG44, CHO GS, RapTr2022
  • Proprietary vectors and analytical rigor
  • Bioreactor evaluation and long-term stability studies
  • Full CMC support from clone selection to tech transfer
  • Expertise in therapeutic, diagnostic, and veterinary biologics
  • Parallel development reduces risk and budget pressure

 

  • Generated clonal cell lines
  • Evaluated single cell clones in fed-batch shake flask
  • Scalable in bioreactor

IgG Epidermal Growth Factor Receptor Blocker (HER-2 Type) or Rec-MC Antibody

HPCL-SEC Purity

Sample ID

Main Peak

HMWS

LMWS

1

98.80

1.20

0.00

2

97.50

2.11

0.39

3

97.81

1.81

0.38

4

97.73

1.91

0.37

5

97.97

1.56

0.47

6

98.85

1.15

0.00

7

96.88

2.66

0.47

8

97.66

1.96

0.39

9

98.84

0.73

0.43

10

97.73

1.84

0.44

IgGA Control

IgGA Start

99.10%

0.90%

0.00%

IgGA End

99.10%

0.90%

0.00%

  • Stable Bulk Pool titers achieved~700mg/L
  • Single cell clone (SCC) from Bulk Pool reached up to 2g/L with clones showing stability up to 60 days
  • Mini pool (MP) generated, and MP reached up to 4.2g/L
  • SCC were generated from the top 2 mini-pools and fed-batch shake flask reached up to 6 g/L
  • Single cell clones show stability over 60 days in respect to cell growth, maintaining high viability and specific productivity
  • Using Aragen’s optimized process from transfection to Single cell clone evaluation completed in 18wks

Summary Table for Aragen Bioscience CHO GS Anti-inflammatory Tumor Necrosis Factor Inhibiting Agent MP SFQ

MP ID

% Viability at Harvest

PVCD E6 c/mL

Harvest Titer (mg/L)

5D7

91

22

4281

3G4

88

16

4245

1A10

83

14

2961

3E5

93

17

2728

4B6

84

13

1123

3G7

90

12

1065

4C2

69

9

687

4E2

86

12

539

Single cell clone generation and evaluation

  • The Top two MPs were used to generate SCC
  • SCC in fed-batch shake flask evaluation reached up to 6g/L

Summary Table for Aragen Bioscience CHO GS Anti-inflammatory Tumor Necrosis Factor Inhibiting Agent MP SFQ

MP ID

% Viability at Harvest

PVCD E6 c/mL

Harvest Titer (mg/L)

5D7

91

22

4281

3G4

88

16

4245

1A10

83

14

2961

3E5

93

17

2728

4B6

84

13

1123

3G7

90

12

1065

4C2

69

9

687

4E2

86

12

539

Stability study of Single Cell Clones (SCC) from Bulk Pool (BP)

  • Completed stability study on top 3 SCC from BP
  • Completed 60 days stability both with and without selection
  • High viability, good growth rate, shorter dT
  • All three SCC showed stable specific productivity up to 60 days
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