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Festival of Biologics

Festival of Biologics

BiSpecific Poster
Bispecific antibodies (bsAbs) have become increasingly important in clinical applications. However, assembly of bsAbs with correct polypeptide chains is one of the major challenges in their production. Random assembly of distinct heavy and light chains leads to non-functional or monospecific impurities. Controlling the relative expression of different polypeptides is the key in the process of manufacturing bsAbs. Here we optimized the vector strategy in ProBio’s Cell Line Development platform (ProCLD) to achieve bsAb manufacturing with high yield and purity. The production and quality can be greatly improved by modulating the expression of distinctive polypeptide chains and thereby optimizing the correct assembly of bispecific antibodies. At ProBio, we identify the vector ratio allowing the highest instance of correct assembly at an early stage during cell line development to ensure optimal production.

 


CMC Poster
The development of stable, high-producing mammalian cell lines remains a pivotal challenge in bioprocessing. Traditional approaches often force a difficult trade-off: achieving high initial product titers can come at the expense of long-term genetic stability, leading to unpredictable productivity drops during extended culture and scale-up. This instability injects significant uncertainty and risk into downstream process development and manufacturing. It necessitates lengthy clone screening campaigns, extensive stability studies, and complex mitigation strategies, ultimately prolonging development timelines and consuming valuable resources. Here, ProBio introduces the ProMax Next-Generation Expression System, a novel solution engineered to break the traditional trade-off between high titer and long-term stability. Leveraging this robust platform, we have launched our ExpressCMC™ service. The predictable, high-yield, and stable cell clones generated by the ProMax platform enable an accelerated, de-risked development path. We demonstrate rapid cell pool recovery, consistent critical quality attributes (CQAs) between pool and clonal derivatives, and a streamlined timeline to deliver Toxicity Batch material in 4 months and GMP Drug Product in 9 months. This integrated solution offers a new paradigm in bioprocessing efficiency, reducing time to clinic while ensuring scalable, high-quality production.


Max-Maletta
Sami-Ullah
Nicolas-Siami
Jialiang-Liu
Yehudi-Chan
SectionTitle02-M

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