Clinical Manufacturing Facilities & Programs

Since the installation of the world’s first 200L → 2000L single-use bioreactor train in 2009 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 flows 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 and we 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.

KBI’s Clinical Mammalian 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

    • 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

    • Segregated and Independent HVAC Zoning

    • Single Pass Air Handling in Critical Areas

    • Electrical Power Backup and Generator

    • Qualified Building Management System

    • Qualified MCB Storage Units

    • GMP Material Warehouse

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

View Capabilities