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Reliable Biologics Development and Manufacturing in Europe

The expert CDMO services you need, where you need them.

  • State-of-the-art facility in Geneva, Switzerland
  • Cutting-edge mammalian-based cell line development (CLD) 
  • Robust and reliable GMP manufacturing services
  • Seamless experience from CLD to drug substance
  • Analytical services for a wide range of biological products

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CDMO Excellence in Europe

Join a legacy of success. Here are 5 things to learn about KBI Biopharma:

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Global Leader in CLD

KBI Biopharma's SUREtechnology Platform™, powered by Selexis®, ranks as a global leader in mammalian cell line development (CLD)

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Trusted European Partner

Located in the heart of Europe's Health Valley and in close proximity to Switzerland, France, and Italy, our diverse and multicultural team represents 20+ nationalities. In fact, we likely speak your language! 

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Track Record of Success

The SUREtechnology Platform™, created in Geneva, has produced cell lines for 10 commercialized products and 170+ additional products that are currently in pre-clinical and clinical trials

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Pioneer in Single-Use

KBI Biopharma has a history of innovation and was the first CDMO to introduce in 2012 the 2000L scale Xcellerex™ single-use bioreactor that de-risks development

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100% Batch Success Rate

In its first year of operations, KBI Biopharma Geneva has manufactured and released 5 batches with a 100% success rate

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Welcome to KBI Biopharma in Europe
Our state-of-the-art site in Switzerland (Geneva)

 

We are committed to delivering secure manufacturing for European biopharma companies with cutting-edge cell line development and analytical and formulation sciences capabilities, combined with reliable cGMP manufacturing services. We meet global regulatory standards set by the ICH, US FDA, EMA, MHRA, and PMDA. 

KBI Biopharma is your trusted partner in Europe, offering comprehensive and tailored solutions to meet your needs of biologics development and manufacturing, at every step in your journey. Discover the advantages of partnering with a reliable CDMO in Europe — connect with our experts.

Welcome to KBI Biopharma in Europe, our state-of-the-art site in Switzerland (Geneva)

 

We are committed to delivering secure manufacturing for European biopharma companies with cutting-edge cell line development and analytical and formulation sciences capabilities, combined with reliable cGMP manufacturing services. We meet global regulatory standards set by the ICH, US FDA, EMA, MHRA, and PMDA. 

KBI Biopharma is your trusted partner in Europe, offering comprehensive and tailored solutions to meet your needs of biologics development and manufacturing, at every step in your journey. Discover the advantages of partnering with a reliable CDMO in Europe — connect with our experts.

Our European Team has supported more than:

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Individual CLD Programs

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Drug Candidates (pre-clinical to commercial)

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Investigational New Drugs (INDs)

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Commercial Biotherapeutics

Running into Roadblocks? We can help.

Get in touch with our European team to keep your project on track and on schedule.

 

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Advanced Cell Line Development 

Leveraging advanced gene technology and a proprietary CHO-based cell line to meet the challenges of cell line development (CLD)

At KBI Biopharma, we are your global partner for mammalian-based biopharmaceutical development here in the heart of Europe.

By combining our proprietary SUREtechnology Platform with our world-class expertise, our CLD services significantly streamline the development of high-performance mammalian cell lines for therapeutic protein production. As a cornerstone of the SUREtechnology Platform, the KBI Biopharma SURE CHO-M Cell Line™ is a proprietary, high-performance cell line derived from CHO-K1 cells and used for the production of biotherapeutics.

Our SUREmAb™ offering is specifically designed for accelerated, efficient monoclonal antibody (mAb) development that is robust and secured. SUREmAb™ delivers high titers (up to 10 g/L) with lower-cost workflows enabling RCB development in as little as 9 weeks, and drug substance release in 11 months.

Delivering the data and insights you need, the reliability and performance you expect, and the global regulatory compliance you require.

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World-Class Analytical Support and Services

Depth of knowledge to future-proof your program with sustained excellence for every molecule at every stage of development

We are fully equipped for release and stability analysis of drug substances, drug products, excipients, and diluents. We have all the relevant characterization capabilities, including GMP-qualified instrumentation and procedures for mass spectrometry and cell-based assay, combined with the expertise of the KBI Biopharma team and versatile product exposure.

We empower biopharmaceutical innovation with cutting-edge analytics and the highest quality standards to expedite product development.

  • Our GMP-grade mass spectrometry services help you develop products, faster
  • Our GMP-grade cell-based assay capabilities enable a deeper understanding of your product
  • Our in-house experts include a trained pharmacist performing clinical in-use studies
  • The Geneva facility is part of a global network within KBI Biopharma for access to experts wherever you are in the world
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Robust cGMP Manufacturing Capacity

For seamless, integrated project process from early development to cGMP Drug Substance certificate of fill

Our Geneva facility strategically combines operations under one roof for vertically-integrated services supporting First in Human (FIH) programs from CLD through to commercial manufacturing. Our depth of experience and expertise in mammalian-based expression streamlines the creation of new biologics and breaks through common bottlenecks and barriers.

We care about your success, and our highest priority is to keep your project on-track, never letting limited capacity or technical issues slow you down.

  • We ensure your work keeps moving forward, in a timely manner, with our open capacity and widespread network of facilities across the EU and US
  • We continually mitigate risks, taking on right from the start derisking strategies, including our pioneering use of single-use bioreactor systems that shrinks the risk of cross-contamination in our Geneva facility
  • With more than 300 individual CLD programs, 170+ drug candidates (ranging from pre-clinical to commercial), and 100 investigational new drugs (INDs) supported, you are not just choosing a CDMO partner — you are joining a legacy of success
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Next-Generation CDMO Services in the Heart of Europe

KBI Biopharma is a trusted global CDMO with a strong track record in world-class biomanufacturing and analytics

 

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ProMIS Neuroscience had a great experience with the Geneva KBI Biopharma team in developing the process and producing cGMP clinical trial drug substance on time. The KBI Biopharma team consistently collaborated with ProMIS in an integrated and strategic manner that produced the drug substance with the required quality attributes and exceeded expectations on yield. We are looking forward to our next engagement.
COO
ProMIS Neurosciences, Inc.
Within the first 5 months of opening our Geneva facility, we completed our first cGMP batch. Now that we've reached our one-year milestone, we are excited to announce the completion of our series of 5 batches completed with a 100% success rate. This performance demonstrates the commitment and skills of a group that adapts to customer needs and navigates around any constraints encountered.
Senior Director, Manufacturing
KBI Biopharma Geneva

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