What are your drug development goals? - Abzena

How can Abzena rapidly advance your next-generation biologic or bioconjugate while reducing risk & ensuring scalability?

Abzena is focused on finding the right solution, at the right development stage, that delivers on your goals. Discover Abzena's end-to-end integrated biologics development programs from preclinical through to commercialization.

Fully integrated to move medicine forwards, faster.

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

1400+ lead candidates discovered, and designed over a 20+ year proven track record with precision and quality.

2000+ conjugates developed for critical assays, and lead candidate selections with over 400 ADCs produced.

You’re not advancing complex biologics and bioconjugates because it’s easy – you’re doing it to deliver the next generation of medicines patients urgently need. Abzena understands the challenges and can deliver the stage-appropriate expertise to accelerate your program without compromising quality. From discovery services, DNA-to-IND and IND-to-BLA programs, through to commercialization, we are ready to take on any challenge, at any stage.

Abzena is a contract research, development, and manufacturing (CRO + CDMO) partner you can count on, at every stage. We are experienced across a wide range of modalities, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates (AOCs), and fusion proteins.

Our integrated, scalable discovery-to-delivery solutions have helped biotech companies and biopharma clients bring their next-generation medicines to the clinic and patients as fast as possible – and with fewer failures. We have the flexibility to offer a complete integrated program or the option to transfer in, depending on where you are in your development pathway.

We are ready to help keep moving your medicine forward. Put our experienced team to the test today.

Supporting Complex Biologics Development

Integrated Cell Line Development - Abzena

From discovery and early development through to commercialization, there are many stages and complex challenges to overcome to meet your goals. Abzena is uniquely placed, at any stage, to partner with you across our integrated programs.

Abzena offers a focused approach:

  • Fully integrated end-to-end biologics development partner with services that span early R&D through commercial capabilities
  • High-quality and trusted data that drives development to increase the likelihood of clinical and commercial success
  • Streamlined regulatory support tailored to your program to ensure successful IND or BLA filing

How can we help?

At any appropriate development stage, we are ready to partner with biotechnology or large pharmaceutical companies alike to develop the next generation of medicines. Together, we can make a life-changing difference for those patients who need them the most. Let’s work together to keep moving medicine forward.

Discovery Services (Hit-to-Lead Candidate)

  • Antibody Discovery (Partnership with Mabqi)
  • Biologics Design & Optimization
  • Bioconjugates Design & Optimization
  • Manufacturability Assessments
  • Immunogenicity Assessments
  • Functional Characterization
  • Research Material Generation
  • In vivo characterization (Via Oncodesign)

Preclinical Development (DNA-to-IND/CTA)

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

Late-Stage Development (IND-to-BLA)

  • Process Development
  • Process Characterization
  • Process Performance Qualification (PPQ)
  • Process Validation
  • Process Control Strategy
  • Analytical Development & Method Validation
  • Extended Viral Clearance Modeling
  • EPoC, HCP Characterization & Validation
  • Late Phase Clinical Trial Material
  • Commercial Batch Manufacture
  • Regulatory Support
  • Filing Gap Assessment

GMP Commercial Drug Substance Manufacturing

  • Scalable Manufacturing Campaigns: With two manufacturing trains, we can simultaneously produce material at different scales—supporting multiple clinical programs or enabling a commercial campaign in parallel with earlier-stage development batches.
  • Regulatory & Analytical Support: Abzena’s analytical and bioassay teams are integrated into every manufacturing campaign, ensuring real-time data on critical quality attributes (CQAs). This holistic support helps sponsors navigate IND/BLA submissions and maintain compliance throughout commercialization.
Comprehensive Global Coverage - Abzena

How is Abzena uniquely placed to help us achieve our goals?

We are a leading end-to-end complex biologic and bioconjugates CDMO + CRO with 6 integrated locations expanding to support end-to-end programs. Our integrated programs leverage over 20 years of experience in de-risking complex biologics, bioconjugates, including ADCs and AOCs, development, and manufacturing. We aim to be the integrated partner that you trust across all development stages, staying true to our values of Scientific Innovation, Quality, and Integrity.

Integrated Bioconjugate & ADC Development Services - Abzena

What sets Abzena apart, and why can we trust you to accelerate our drug development program?

For over 20 years, we have partnered across the globe with emerging biotechnology and large pharmaceutical companies to develop the next generations of medicines. By working together, we can make a difference for those patients who need them the most.

What sets Abzena apart?

  • 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

Partnering for Patient Impact

GMP Manufacturing Suite - Abzena

At Abzena, we understand that the science of what we can do together is complex. Moving medicine forward can be risky and takes time. We cannot do this alone. We are always looking to help our customers accelerate toward a successful outcome. A future that moves new medicines forward through our combined scientific innovation that delivers life-changing treatments to the clinic and patients in need. That is why we have partnerships and collaborations with biopharma market leaders across our early development services and programs.

Let’s move medicine forward - Abzena

Let's work together to move your medicine forward.

We enable you to bring life-changing medicines to patients in need faster.