How can our biologics drug development program move forward from DNA-to-IND faster?

Abzena's DNA-to-IND, CTA-enabling programs provide an integrated, accelerated pathway to take a molecule from DNA sequence to IND submission.

Move forwards from DNA-to-IND/CTA faster with Abzena.

Reduced Risk

70+ integrated programs delivered in support of IND across multiple complex biologic modalities

Faster Timelines

Stable Pools in 3 weeks, RCB in 10 weeks, GMP-ready in 6 Months through AbZelectPRO™

Uncompromised Quality

Quality control and robust data underpin our DNA-to-IND programs

The pathway from DNA to an investigational new drug (IND) application and clinical trial application (CTA) can be long, complex and costly. For over 20 years, Abzena have proven that we know what it takes to develop a successful biologics drug candidate – from GMP-ready cell line development through to Clinical Trial Application (CTA) & Clinical Manufacturing. We offer a seamless, accelerated pathway to IND filing without compromising on program design, data integrity, and regulatory readiness.

Our integrated DNA-to-IND programs support a full range of modalities – from monoclonal antibodies (mAbs) to complex biologics like antibody-drug conjugates (ADCs), antibody oligonucleotide conjugates (AOCs) and bispecifics.

When appropriate, you can transfer your established cell line or process, at any development stage and we’ll work with you to achieve your next milestone faster.

Fully integrated technology platforms and robust development methods are the key to delivering a faster DNA-to-IND approach. Abzena’s enhanced GMP-ready cell line development platform, AbZelectPRO™, increases productivity, titers, yields, and overall performance.

IND-Enabling Activities

We can de-risk your program and reduce time to IND filing and clinical trial application (CTA). Our DNA-to-IND program has been built for speed, leveraging our expertise in rapidly generating the data needed for IND filing. Delivered as one program, our solution integrates all IND-enabling activities required to reach clinical trial application (CTA) and first-in-human (FIH) studies.

Program essential are:

  • Cell Line Development & Cell Banking
  • Process & Analytical Method Development
  • Formulation Development
  • Reference Standard Characterization
  • Tox Material Supply
  • Clinical Manufacturing
  • Regulatory Support

Ready to move forward to IND?

Discover how Abzena’s integrated DNA-to-IND program solutions can help you move your molecule forward to the clinic faster. Complete the form and one of our experts will be in touch to discuss your program goals.