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Solutions Large Molecules Discovery Cell Line Development 2

Cell Line
Development Services

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
  • Single cell clones (SCC) up to 8g/L in fed-batch flasks
  • Optimized from transfection to SCC in just 16 weeks
  • Mini pools up to 4.2g/L | Bulk pools up to 700mg/L
  • 60+ days of stability in growth and productivity

RapTr2022: The Express Lane to IND

If time is your top priority, RapTr2022 delivers.

  • Royalty-free, cost-efficient, and fast
  • DNA transfection to Research Cell Bank (RCB) in just 18 weeks
  • Built for fast-track biologics and accelerated IND filings
  • Up to 8g/L protein expression
  • Advanced imaging ensures clonality and consistency

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
  • Therapeutic Area Expertise: Inflammatory diseases, oncology, rare genetic disorders, and more
  • Process Optimization: Tailored solutions for scale-up and cost-effective production

The Aragen Advantages

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

Cell line development is a process by which a large population of identical cells is created, containing the gene that, on translation, encodes the biologic (recombinant proteins, monoclonal antibodies, bi-specific monoclonal antibodies, fusion proteins, vaccines). Chinese Hamster Ovarian (CHO) cells and Human Embryonic Kidney (HEK) cells for example, are among the most effective and prolific biological factories, and their cultures are utilized to produce novel cell lines. Apart from biologic production stable cell lines are also used in drug screening and gene functional studies.

To ensure the successful insertion of the vector in the host cell line several transfections are performed. When the transfected cultures are pooled together, it is called bulk transfection. To identify the best transfected cells or hot spots the bulk transfection is divided into several tiny populations called minipools and the leftover is referred as the bulkpool. Minipools help identify the high producing cells. Bulkpool is used for a fed-batch production run to generate materials that is purified and analysed as an analytical standard or benchmark against the expected product quality.

Clone screening is a process by which the transfected pools is analyzed for the cells those carrying the desired genomic changes and expressing the target protein. clone screening is a complex process because the performance of the clones is unpredictable in different culture conditions therefore the higher the number of clones screened the greater are the chances of discovering the high producing clone. Once a few efficient clones have been identified, multiple assays should be carried out to build a thorough picture of the features of each before selecting the best performing clone.

Clonality is one of the most crucial steps in guaranteeing cell line quality and safety. The FDA currently require evidence that each cell line used in manufacturing has been generated from a single cell. Single cell cloning (SCC) is a method in which single cells are separated from the pool of transfected pool such that final MCB is generated from the single cell and produces identical product. SCC is currently achieved using two commonly used methods i.e., single cell sorting using FACS and limiting dilution.

Research cell bank is a small cell bank produced under research conditions used for the production of a biotherapeutic for research purpose only. A master cell bank (MCB) is generated from a research cell bank (RCB) when cell line development is completed. Cells from a RCB are thawed and expanded, and when cell counts reach the desired number, a MCB is prepared and stored in a LN2 freezer.

FAQ

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