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 no easy task. Large molecules are complex structures requiring robust expertise and the best technologies applied. At Abzena, we can help you maintain biosimilarity, critical for the regulatory approval of biosimilar products, by developing your cell line using the originator cell type.

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Whether you decide to stay with the originator or switch to a new host cell line, Abzena can advise on strategies for clone selection, process development and comparability studies to demonstrate that critical quality attributes affecting efficacy and safety are maintained. We have access to a range of CHO, NS0 and Sp2/0 cell lines adapted to serum-free growth media.

Our biosimilar cell line development experts de-risk your project by providing additional product quality assessments to ensure that the Quality Target Product Profile (QTPP) is on track to match originators. 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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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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AbZelectPRO™: Enhanced Cell Line Development

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