Clinical Manufacturing Facilities & 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 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

    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