Improving Cell Line Development Efficiency With AbZelect™

To advance innovative biologic therapeutics from the development pipeline into clinical phases, developers must demonstrate that their drugs can be manufactured consistently while adhering to stringent quality standards. In the United States, this critical step is formalized through the submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). The journey to IND is often marked by intense pressure from stakeholders and investors, who seek rapid progress to demonstrate a return on investment.

One of the most significant hurdles on the pathway to IND is cell line development (CLD), a complex and time-intensive process that can take up to a year to produce a stable cell line. This bottleneck can delay progress and increase costs, creating challenges for developers striving to meet ambitious timelines.

Abzena addresses these challenges with its innovative AbZelect™ and AbZelectPRO™ platforms, designed to accelerate and optimize the CLD process. These platforms enable the efficient progression from lead candidate sequence to research cell bank generation in just 15 weeks. By streamlining timelines and reducing risks in downstream processes, Abzena’s solutions enhance efficiency, helping developers navigate the IND pathway more effectively and meet critical milestones with confidence.