SUREmAb™

Monoclonal Antibody Development, the Way it's Meant to be.

Making Monoclonal Antibody Development a SURE Thing

Built on the SUREtechnology Platform, SUREmAb shortens development and manufacturing for monoclonal antibodies (mAbs). It enables RCB development in as little as 9 weeks* and drug substance release in 11 months*. Specifically designed for accelerated, efficient mAb development that is robust and secured, SUREmAb projects achieve high titers of up to 10 g/L with a streamlined, lower-cost workflow that delivers the data and insights you need, the reliability and performance you expect, and the global regulatory compliance you require.

• Fast solutions to go from DNA to GMP drug substance in 11 months*
• Optimized, yet comprehensive, mAb development journey
• Efficient processes for high titers and exceptional yield
• Proven platform with a track record of success
• Globally capable with time-efficient development

KBI Biopharma's SUREmAb offering is built on the robustness of the SUREtechnology Platform, delivering the quality you expect with a streamlined workflow for straightforward projects. Simple mAb development is a SURE thing with our rapid solution that preemptively navigates technical hurdles for the same quality under accelerated timelines.

With SUREmAb™, you've met your Match

Efficiency and Speed, Simplified

In your mission to advance science and improve lives, every day matters. That's why SUREmAb has been specifically designed to accelerate development timelines, with our platform delivering RCBs in as little as 9 weeks*, and taking you from DNA to GMP drug substance in 11 months*.

Optimized for Your Advantage

SUREmAb is engineered for robust, secured monoclonal antibody development, achieving high titers of up to 10 g/L and offering a streamlined, lower-cost workflow to optimize operational efficiency and maximize return on investment (ROI).

Proven Excellence You Can Trust

With over 15 years of mAb development experience, more than 150 unique therapeutic mAb projects, and 7 commercialized mAbs leveraging the SUREtechnology Platform, you're not just choosing a service - you're joining a legacy of success.

Innovation With Alleviation of Royalties

Our commitment to your success extends beyond our services. By continuing into clinical and commercial manufacturing with KBI, license fees will be waived, enabling you to make the most of our innovation without ongoing financial constraints.

Global Compliance, Local Presence

We are with you wherever you go, meeting global regulatory standards set by the US FDA, EMA, and PMDA, and offering global development and manufacturing capabilities across our sites in the United States and Europe.

Development Success is a SURE Thing with SUREmAb

With optimized processes for efficiency and speed, SUREmAb delivers high titers with lower-cost workflows

SUREmAb™ Embraces the power of the SUREtechnology Platform™ for Monoclonal Antibody Development

With SUREmAb, you get development services that are specific to your molecule and unique to our proprietary platform that stems from patented technology to deliver exceptional results. Our robust clinically- and commercially-proven expertise, combined with efficient workflows that streamline timelines and cost, take you from DNA to RCB to IND in a seamless journey that is custom-tailored to your molecule.

Expect leading performance with our SURE CHO-M Cell Line™

Our proprietary SURE CHO-M Cell Line is a game-changer in biologics production. Derived from CHO-K1 cells, this high-performing cell line was specifically developed to overcome protein expression bottlenecks. It enables the expression of a diverse range of molecules with high titers, ensuring versatility, high performance, and stability over 60 generations.

* Please note: The SUREmAb offer does not apply to mAb-based biosimilar projects or for any IgG shape-derived proteins that are different from an intact IgG format - including bsAbs, Fc fusions, and IgG fragments - as well as other protein classes outside of IgGs. Timeline estimates are subject to open manufacturing capacity and may vary by project.

For additional, diverse molecule formats, our SUREtechnology Platform offers robust solutions, including workflows and optimizations for difficult-to-express proteins. Please contact us for further information or to answer any questions you have about the SUREmAb offering, cell line development services, or additional molecule expression options.

Monoclonal Antibody Development, the Way it's Meant to be

KBI Biopharma is a trusted global CDMO with a strong track record offering best-in-class mammalian-based expression for breakthrough molecule types.