Streamlined Development for Efficient Production of Bispecific Molecules Using an Integrated Platform Process

Séverine Fagète, PhD, Vice President Cell Line Services

There is a global need for high quality, effective off-the-shelf therapies that can be used immediately, while concurrently avoiding supply chain issues and mitigating process complexities. Bispecific antibodies (bsAbs) are constructed to help meet this need due to their ability to bind to two or more different epitopes, thereby allowing them to perform multiple discrete mechanisms of action.

This webinar will demonstrate a breakthrough platform approach that encompasses the efficient production of bispecific molecules in an integrated, streamlined way, from CLD (cell line development) to cGMP manufacturing. The leverageable integrated workflow from Selexis and KBI Biopharma generates high quality clinical bulk drug substances under accelerated timelines.

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Your Questions, Answered.

Webinar registrants and participants were invited to submit their questions both before the webinar and during the live event. Questions addressed include: 

• Do you have a proprietary CHO cell line that is used for transfections?
• Are some cell lines better for specific format bispecifics? 
• For the transfection of 2HC and 1LC, do you use 3 different selections for the 3 vectors?
• Could you describe some of the molecules you have worked with where an additional domain/molecule was appended to the Fc domain - any challenges associated with expressing those molecules?
• How do you determine the copy number of your plasmid in the cells? How do you control this parameter as it for sure has an influence on the performance of your winner clone?
• How do you address cells and best clone selection? Are you using FACS, MACS Quant Tyto, Berkeley Light, etc?
• How well does process understanding and improvement using early candidate pools translate to the final clone? 
• How many different types of pairing technologies have you worked with?
• How do Selexis and KBI coordinate project activities with one another?
• Are you developing any bsAbs with a payload? If so, what types of payloads (radioactive, toxic, etc)?
• What is your experience using cell lines that produce afucosylated mAbs for enhanced ADCC?
• Are development timelines of bispecific projects similar to mAb projects?

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Access The Bispecific Webinar!