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Clinical Manufacturing

Accelerate First In Human clinical manufacturing for mammalian-based biopharmaceuticals

Manufacturing New Biologics, At Scale

GMP Drug Substance Manufacturing for FIH and Clinical Resupply Programs


After becoming the first CMO in the world to implement the 2000L scale Xcellerex™ single-use bioreactor at our Durham, NC, USA site, KBI Biopharma immediately began delivering GMP Drug Substance supplying FIH (First in Human) and clinical resupply programs.

In 2014, our proven track record for drug substance delivery facilitated mammalian clinical manufacturing suite space expansion, adding another Seed Expansion, 500L→2000L bioreactor train, and purification suite.

In 2022, we expanded our cGMP mammalian clinical manufacturing capabilities within our site in Geneva, Switzerland, mirroring the Seed Expansion, 500L→2000L bioreactor train, and purification suite.


Advanced Mammalian Clinical Manufacturing for cGMP-compliant New Biologics

Our mammalian clinical manufacturing facilities provide your biotherapeutic programs with solutions for robust product segregation, pre-and post-viral downstream processing areas, and cross-contamination prevention.

The segregated HVAC design and personnel, material, and equipment flow together with the deployment of end-to-end single-use technology allow for maximum flexibility and rapid turn-around, all the while protecting your timelines and investment.

The mainstay of this success is our greatest asset - our team members. We are a diverse collection of experienced industry professionals who understand the impact these new proteins, antibodies, and vaccines have on human health. Each day, our experts put both their hearts and their wealth of knowledge to work. United, our team delivers outstanding mammalian clinical manufacturing results for you biotherapeutic program, tackling challenges ahead for streamlined and reliable clinical manufacturing program that accelerate your path to First In Human (FIH). 

  • 4x (500L→2000L) bioreactor train and purification suite
  • Multiple trains with single-use (disposable) technology
  • 24x7 manufacturing operations

KBI’s Clinical Mammalian Capabilities

Upstream Production Capabilities

  • Single-Use (Disposable) Technology

  • Seed Expansion Stages: Shake Flasks, Wave Bioreactors, 200L Seed Trains

  • Production Stages: Fed-Batch Cultures: 200L (40-200L w.v.) and 2000L (400-2000L w.v.)

  • Harvest Clarification by Depth Filtration and Single-Use Centrifugation

  • On-The-Floor Quality and Technical (SME) Oversight

  • 24 hours 7 days a week operations

Downstream Production Capabilities

  • Single-Use (Disposable)Technology

  • Dedicated Pre and Post Viral Downstream Processing Areas

  • Single-Use Chromatography and UF/DF Technology

  • On-The-Floor Quality and Technical (SME) Oversight

  • 24 hours 7 days a week operations

Facility/Utility Capabilities

  • Segregated and Independent HVAC Zoning

  • Single Pass Air Handling in Critical Areas

  • Electrical Power Backup and Generator

  • Qualified Building Management System

Warehousing and Storage

  • Qualified MCB Storage Units

  • GMP Material Warehouse

  • Ambient, 2-8°C, -20°C, -70°C Storage

Ready to Learn More? Get in Touch with our Team.


Contact Us

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