Abzena Cambridge

Biosimilar Cell Line Development & Manufacturing

Accelerating biosimilars development with our expertise and technology platforms.

Through our commitment to collaboration and reaching RCB faster, we ensure that your biosimilar cell line is developed with precision, scalability, and long-term success in mind.

Developing and manufacturing biosimilars is a complex process that demands deep scientific expertise, advanced technologies, and regulatory precision. At Abzena, we support every stage of biosimilar cell line development, helping you maintain biosimilarity – critical for regulatory approval – by developing your cell line using either the originator or an alternative host system.

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Whether you choose to remain with the originator or move to a new host, our scientists provide expert guidance in cell line engineering, clone selection, process development, and comparability studies to ensure that critical quality attributes (CQAs) linked to safety and efficacy are maintained.

We have access to a wide range of CHO, NS0, and Sp2/0 cell lines adapted for serum-free growth, providing flexibility in design and production. Additional early upstream process development can be performed using 15 or 250 ml multi-parallel robotic bioreactor systems to better match originator CQAs.

We offer comprehensive analytical and bioassay packages to support clone selection minimizing process development time.

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An Integrated Approach to Biosimilar Manufacturing

EpiScreen® 2.0: Smarter Immunogenicity Testing - Abzena

Our biosimilar manufacturing expert’s de-risk your programme by conducting comprehensive product quality assessments that keep the Quality Target Product Profile (QTPP) aligned with the originator. Early upstream process development can be performed using 15 mL or 250 mL multi-parallel robotic bioreactor systems to optimise performance and closely match originator CQAs.

This integrated approach ensures that biosimilar cell line engineering meets both technical and regulatory expectations while supporting commercial scalability.

Leading Biosimilar Cell Line Development Expertise

AbZelectPRO™: Enhanced Cell Line Development - Abzena

Abzena can provide the integrated solutions that your biosimilar programs need. We understand that the success of a biologic depends not just on a multitude of individual steps. That is why we developed our AbZelectPRO™ CLD platform. With this we can reduce lead candidate sequence to research cell bank generation timelines to 10 weeks, and minimize risk for future processes to enhance efficiency. In combination with our state-of-the-art facilities, leading scientists, and regulatory expertise, we are an ideal partner to develop and deliver stable, high producing, functionally characterized biosimilar cell lines.

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Cell Line Characterization

Biologics Analytics & Bioassays - Abzena

With over 20 years of expertise and a commitment to quality excellence, we understand that the safety and quality of your biological products starts with the right cell line. Our streamlined cell line characterization services offer standard product quality testing including sterility, mycoplasma, cell identity, gene sequences, and stability.

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Biosimilar Cell Line Development FAQs

What is biosimilar cell line development?

Biosimilar cell line development creates a stable cell line that produces a protein matching the reference biologic in structure and function. The goal is consistent quality and regulatory compliance.

What are the main stages of the biosimilar development process?

Key stages include cell line creation, process development, comparability studies, and regulatory approval. Each step must meet biosimilar manufacturing standards.

Why is cell line development critical in biosimilar manufacturing?

The cell line defines product quality and consistency. A stable clone ensures uniform glycosylation, yield, and bioactivity across all production batches.

What are common challenges in biosimilars development?

Challenges include matching molecular attributes, maintaining process consistency, and meeting regulatory comparability requirements.

How does Abzena support biosimilar development?

Abzena delivers end-to-end biosimilar development support, linking cell line development, analytical testing, and biosimilar manufacturing for regulatory-ready programs.

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