How can your next-generation biologic or bioconjugate move 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.

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Move forward 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

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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 has 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) and 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 stage of development, 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.

Start Your Program

IND-Enabling Activities

We can de-risk your program and reduce the 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 essentials are:

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

How is Abzena uniquely placed to help us achieve our IND goal?

Comprehensive Global Coverage - Abzena

At Abzena, our stage-appropriate DNA to IND programs are powered by a strategically integrated global network of six facilities. These have been purpose-built to seamlessly support complex biologics and bioconjugate programs from discovery, through preclinical development, and on to commercialization.

By operating as one connected network, rather than a collection of standalone sites, we enable faster decision-making, streamlined technology transfer, and reduced risk across preclinical development. This integration allows our clients to eliminate handoff delays, maintain continuity, and accelerate timelines with confidence.

With over 20 years of proven expertise in de-risking complex biologics and bioconjugates – including ADCs and AOCs – our focused approach delivers consistent quality, deep scientific insight, and scalable GMP-ready manufacturing solutions.

Integrated Locations

What sets Abzena's preclinical development programs apart?

Enhanced Cell Line Development - Abzena (Cambridge)

What sets Abzena apart is its ability to seamlessly connect discovery, design, and early development within a single, coordinated framework. This integration enables faster iteration, more informed decision-making, and earlier de-risking – ultimately accelerating timelines and improving the probability of success.

Abzena’s preclinical development programs are shaped by a deep scientific expertise for complex biologics and a global, collaborative mindset. With over 20 years of experience partnering with both emerging biotech innovators and leading pharmaceutical companies, Abzena brings a proven track record of advancing complex biologics from DNA toward IND and clinic with confidence.

Why Abzena?

Partnering for Patient Impact

GMP Manufacturing Suite - Abzena

We partner with you to help speed your pathway to successful outcomes, combining our scientific expertise with your preclinical DNA to IND development goals. Together, we can move your ideas forward more efficiently, bringing transformative therapies to the clinic and, ultimately, to the patients who need them most.

Partnering with Abzena, you can expect:

  • Access to Genuine Scientific & Technical Experts
  • Proactive Problem Solving to Ensure Downstream Success
  • Diverse & Interconnected Expertise Under a Single Organization
  • Driven by Innovation to Streamline Development
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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.