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Clinical Mammalian

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 manufacturing suite space expansion, adding another Seed Expansion, 200L→2000L bioreactor train, and purification suite.

Learn more about KBI’s deployment of single-use technologies

Our multi-product manufacturing facilities provide 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.

Learn more about our cGMP biologics manufacturing services

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 and put our hearts and experiences to work delivering outstanding quality products.

We expect you will feel right at home as you come to know KBI Manufacturing and our commitment to your company and your molecules.

2x (200L→2000L)

bioreactor train & purification suite


Multiple Trains

single-use (disposable) technology


24x7

manufacturing operations

clinical mammilian manufacturing

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