The journey of a biologic drug from concept to market hinges on the quality of the cell line at its core. Effective cell line development (CLD) that delivers consistent performance, stability, and scalability unlocks faster development cycles, tighter cost control, and smoother regulatory pathways. Conversely, instability or variability at this stage can cascade into costly delays and uncertainty, impacting the entire program’s momentum.
Biopharma teams often face challenges ensuring stable productivity, speeding IND readiness, and scaling processes smoothly. Overcoming these hurdles requires both scientific precision and proven technology platforms that can reliably deliver results.
Here’s how we help you navigate these critical CLD challenges—and why Aragen’s CHOMax™ platform is designed to transform your biologics development journey.
Variability in protein expression across cell clones is a common bottleneck, caused primarily by unstable or random gene integration. This leads to inconsistent yields, forcing you into lengthy screening campaigns that delay progress.
Traditional plasmid integration methods can cause fluctuations due to unpredictable insertion sites. The solution lies in precise, stable gene integration that minimizes variability.
TnT Transposon Technology, which uses mobile genetic elements to insert genes efficiently and stably into the host genome, significantly improves expression consistency. At Aragen, we utilize this technology to enable highly stable and efficient gene integration. By reducing expression variability, it allows teams to focus on promising clones sooner and with greater confidence—saving precious development time.
Speed is a critical factor in biologics development, but many CLD workflows are slowed down by manual screening, inconsistent processes, or bottlenecks in analytics. Delays at this stage can cascade into longer clinical timelines and lost market opportunities.
By integrating rapid, high-throughput screening technologies with streamlined, standardized workflows and automated analytics, the CLD process can be significantly accelerated without compromising cell line quality or stability. This lets you move quickly from clone selection to manufacturing and IND submission, reducing costly hold-ups.
Aragen’s CHOMax™ platform exemplifies this strategy, delivering stable research cell banks (RCBs) in just 16 weeks. Backed by years of platform refinement, advanced gene integration techniques, and robust quality controls, this accelerated timeline empowers your development program to progress swiftly and confidently while maintaining the highest standards of consistency and regulatory compliance.
Performance at lab scale doesn’t always predict success in large-scale manufacturing. During scale-up, clones may experience altered growth rates, reduced productivity, or changes in product quality, all of which can introduce significant risks and increase costs.
Selecting clones with strong metabolic health and stress tolerance is essential to minimize these challenges. Such clones maintain stable expression and growth characteristics, ensuring that production efficiency and product quality are preserved as you move from small-scale experiments to commercial bioreactors.
Aragen’s CHOMax™ platform is specifically engineered for exceptional scalability across diverse bioreactor formats, ensuring that your clone’s high-level performance in early fed-batch runs translates seamlessly to large-scale production. This consistency supports a smooth, risk-mitigated path from development to commercial manufacturing.
Regulatory agencies require exhaustive documentation and traceability throughout cell line development. Platforms that lack established regulatory acceptance or comprehensive cell line histories can trigger additional scrutiny, complicating submissions, and potentially delaying approval timelines.
Utilizing well-validated platforms with a proven regulatory track record streamlines your approval process. Comprehensive documentation, including detailed cell line history packs, facilitates smoother interactions with regulatory bodies and reduces the risk of compliance issues.
Aragen’s CHOMax™ platform boasts a strong global presence, supported by over 110 licenses and more than 86 accepted regulatory filings worldwide. This extensive regulatory footprint gives clients the confidence to prepare robust submissions and engage regulators effectively, accelerating your path to clinic and market.
Royalty fees on proprietary CHO systems can significantly increase production costs, reducing your profit margins and complicating budgeting across the product lifecycle. These fees often become more burdensome as production scales up, impacting commercial viability.
We offer royalty-free access to the widely accepted CHO-GS and CHO-DG44 platforms, giving our clients full freedom to scale their manufacturing without worrying about escalating royalties. This approach empowers them to better control their cost of goods sold (COGS), improve financial predictability, and reinvest savings into innovation and market expansion. Additionally, leveraging well-established CHO platforms simplifies technology transfer and regulatory filings, further reducing hidden costs and delays.
Today’s biologics aren’t just about quantity—they must deliver superior functional quality to maximize therapeutic benefit. For antibody therapies, enhancing antibody-dependent cellular cytotoxicity (ADCC) is key to improving clinical outcomes.
Glycoengineering plays a pivotal role in optimizing these functions. Aragen’s Fut∞KO glycoengineered GS knockout CHO cell line enables full afucosylation of antibodies, a key modification that enhances ADCC and boosts therapeutic potency. This advanced glycoengineering technology ensures your molecule combines high productivity with superior functional quality, providing a competitive advantage in efficacy and patient benefit.
With over 200 successful programs, Aragen’s CHOMax™ platform represents a convergence of speed, stability, scalability, and science-driven innovation tailored to your biologics.
Cell line development is a pivotal step in your biologics journey—where choosing the right science and partner can make all the difference. By addressing your biggest pain points with proven technologies and integrated workflows, you can reduce risk, speed timelines, and deliver consistent, high-quality products.
At Aragen, we understand the challenges you face and offer the speed, precision, and confidence you need to advance from discovery to development and successful manufacturing.
Ready to fast-track your biologics?
Contact Aragen to explore how CHOMax™ can accelerate your CLD success.
