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To progress innovative new biologic therapeutics from development to clinical phases, it is essential for developers to prove that the drug can be consistently manufactured while meeting quality standards. In the United States, this is done through the submission of an Investigational New Drug Application (IND) to the Food and Drug Administration (FDA).
Developers face pressure from stakeholders and investors to quickly submit IND applications and show a return on investment. However, mammalian cell line development (CLD) often poses a challenge, sometimes taking up to a year to establish a stable cell line.
Abzena’s AbZelectPRO™ platform provides a solution by simplifying CLD, reducing lead candidate sequence to research cell bank generation timelines to 10 weeks, and minimizing risks for future processes to enhance efficiency.
As a life science contract development and manufacturing organization (CDMO) with over two decades of experience in cell line development, Abzena has expertise in expressing biologics ranging from antibodies, antibody fragments, fusion proteins, and vaccines.
Discover our cell line development (CLD) services.
Download our info sheet today to learn more about the potential benefits of our AbZelectPRO™ technology platform.