2x (200L→2000L)
bioreactor train & purification suite
Multiple Trains
single-use (disposable) technology
24x7
manufacturing operations
2x (200L→2000L)
bioreactor train & purification suite
Multiple Trains
single-use (disposable) technology
24x7
manufacturing operations
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.
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
Are you looking to accelerate your program or just want to learn more about our services?
Connect with our team and we will get back to you quickly.
View CapabilitiesConnect with our team and we will get back to you quickly.
View CapabilitiesCopyright © 2019 KBI Biopharma. All Rights Reserved. | Privacy Policy