Abzena Cambridge

Monoclonal Antibody (mAb) Development

Abzena design and engineer monoclonal antibodies (mAbs) for the next generation of medicines. We have 20+ years of experience in mAb development including bispecific and multispecific antibodies (BsAbs & MsAbs).

Since Abzena was founded over 20 years ago, we have worked with global clients to develop mAbs that have significantly transformed the treatment landscape for cancer, immunology, and many other therapy areas.

Monoclonal antibodies (mAbs) remain one of the most successful and rapidly expanding therapeutic modalities in modern medicine, underpinning breakthrough treatments across oncology, immunology, neuroscience, and infectious disease. As therapeutic complexity increases and timelines compress, biopharmaceutical developers require fully integrated partners capable of seamlessly advancing monoclonal antibody programs from early discovery through clinical and commercial supply. As an experienced CDMO + CRO, Abzena has played a leading role in advancing the science of mAbs and bioconjugates. Our integrated upstream and downstream mAb development, optimization and manufacturing services include GMP-ready cell line development (CLD) have been proven to accelerate timelines, particularly through the preclinical DNA-to-IND stage.

Abzena are at the forefront of the development of therapeutic monoclonal antibody-based therapeutics across a variety of disease indications including oncology and immunology – details of which can be found in our resources which includes case studies.

The development of monoclonal antibodies requires the seamless integration of discovery, engineering, developability assessment, cell line development, manufacturing, and regulatory readiness. Abzena’s end-to-end programs are specifically designed to address these challenges, enabling faster, de-risked progression from candidate to clinic.

Through our facilities and end-to-end solutions, we can move your program all the way from discovery through commercial through our uniquely integrated programs that have been proven to shorten timelines to IND or BLA and beyond.

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What are monoclonal antibodies (mAbs)?

Biologic Discovery, Development & Manufacturing - Abzena

Monoclonal antibodies (mAbs) are laboratory-produced proteins designed to mimic natural antibodies in the immune system. They are made from identical immune cells cloned from a single parent cell, meaning they all bind to one specific target (antigen), such as a protein on the surface of a cancer cell or pathogen.

Once attached to their target, monoclonal antibodies can help treat disease in several ways, including blocking signals that allow cells to grow, marking cells for destruction by the immune system, or delivering drugs or radiation directly to target cells.

End-to-End mAb Solutions from Discovery to GMP Manufacturing

Abzena delivers comprehensive monoclonal antibody development services across the entire value chain – combining deep scientific expertise, advanced platforms, and regulatory experience to de-risk development and accelerate time-to-clinic. Our integrated capabilities enable a single, strategic partnership to support your program from candidate selection to GMP manufacturing.

Discovery Services (Hit-to-Lead Candidate)

Let’s start smart and finish fast. Early derisking and optimization with the future in mind.

  • 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)
Integrated Discovery Services

Preclinical Development (DNA-to-IND)

Go from DNA to RCB in just 10 weeks with AbZelectPRO™.

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

Late-Stage Development (IND-to-BLA)

Accelerated late-phase development and manufacturing solution.

  • 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
Integrated Late Stage Development

GMP-Ready Cell Line Development: Accelerating the Critical Path

AbZelectPRO™: Enhanced Cell Line Development - Abzena

At Abzena we are ready to meet our customers increasing demand for mAb-derived biotherapeutics, and meet the challenge of delivering biologics at scale, reliably. We understand that the success of moving a biologic project from lab to commercial hinges on high-quality, GMP-ready cell line development (CLD). CLD is the foundation of biotherapeutic development and manufacturing. By getting the processes right the balance of high quality, high yield and speed needed to successfully bring a biologic to market can be achieved. At the core of Abzena’s CLD offering is our AbZelectPRO™ platform.

AbZelectPRO™ has been designed for speed and efficiency. It compresses timelines, offering:

  • Stable pools generated in as little as 3 weeks
  • DNA to research cell bank (RCB) in ~10 weeks
  • GMP-ready cell lines in approximately 6 months
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The Abzena Advantage: One Partner. Less Time in Development. Less Risk.

We remove the gaps, dependencies & delays that slow your program to IND.

mAb Services - End-to-End Capability

End-to-End
Capability

From discovery through GMP manufacturing, Abzena provides a single-partner solution that eliminates the inefficiencies of multi-vendor workflows.

mAb Services - De-Risked Development

De-Risked
Development

Early developability assessment, advanced protein engineering, and robust CLD platforms reduce technical and regulatory risks throughout the program lifecycle.

mAb Services - Accelerated Timelines

Accelerated
Timelines

By integrating activities and enabling parallel workflows, Abzena compresses development timelines and helps programs reach clinical milestones faster.

mAb Services - Proven Expertise

Proven
Expertise

With over 20 years of experience and hundreds of projects delivered, Abzena brings a track record of solving complex biologics challenges and advancing therapeutic candidates toward the clinic.

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What sets Abzena apart?

Comprehensive Global Coverage - Abzena

For over 20 years, we have partnered across the globe with emerging biotechnology and large pharmaceutical companies to develop the next generation of medicines. Drawing on our rich heritage and those decades of experience in integrated and tailored biologics program delivery, we aim to be the mAb development partner that you trust across all stages. With quality at the front of everything we do, we plan the best route, steering your drug program toward regulatory approval, and getting it quickly and effectively to patients.

Partnering with Abzena, you can count on:

  • 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
Why Abzena?

Partnering with Abzena for Your mAb Development & Manufacturing Needs

As the future of monoclonal antibody development unfolds, partnering with the right expertise is crucial for your success and helps to de-risk the development process. Abzena are committed to the development of complex mAbs and moving next-generation medicine forward.

If you’re looking to enhance your mAb derived development process with state-of-the-art technology and expert guidance, we invite you to contact Us.

Discover how Abzena can support your mAbs program to improve patient outcomes today.

Related Services

Our genuine scientific and technical experts focus and collaborate with you on streamlining mAb development and manufacturing programs proactively.

Antibody Engineering

Our experts combine antibody design, protein engineering and analytics expertise to design drug candidates, from antibodies, Fab fragments, and fusion proteins, with minimal liabilities and ...

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Bispecific & Multispecific Antibody Development

We design and engineer a multitude of recombinant antibodies for immunotherapy, including bispecific and multispecific antibodies (BsAbs & MsAbs).

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Bioconjugate Development

We identify and de-risk your bioconjugate and ADC clinical candidates for development ensuring stage-specific milestones are met.

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Mammalian Cell Line Development

Achieve stable pools in 3 weeks, accelerate from DNA to RCB in just 10 weeks and GMP in 6 months with our industry-leading mammalian cell line development services.

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Process Development & Optimization

Seamless upstream and downstream biologics process development, optimization and cGMP manufacturing from cell line development (CLD) to patient.

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Formulation Development

With a focus on aligning your drug candidates to the ideal target product profile (TPP) we develop a comprehensive range of formulation development packages.

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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.

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