KUBio manufacturing facility

A turnkey process and facility solution for cGMP mAb production that dramatically reduces time to market.

A prefabricated cGMP biomanufacturing facility operational in 18 months…for a fraction of the cost

The KUBio facility is designed for flexibility and includes FlexFactory, a configurable production line that can improve operational efficiency and minimize infrastructure.

Invest when success rate is high

Investment in a traditional biomanufacuring facility is typically made years ahead of FDA approval. At that point, the molecule’s success rate is undetermined. With KUBio, you can defer that decision until after phase III clinical trials, when the success rate is more assured.

Case study: the magic of the parallel processes at JHL Pharmaceuticals

The modules that comprise a KUBio facility are produced in a controlled environment. We specify each module’s design to the materials needed for that particular room. Simultaneously, customers prepare their planned sites for the arrival of their modules.

WATCH KUBio UNFOLD FOR JHL IN CHINA

FlexFactory–the heart of KUBio

Once the KUBio modules are in place, the preconfigured FlexFactory biomanufacturing process line is installed. Process requirements are balanced for batch scale and multiproduct capacity needs and the integrated components work together to deliver and optimized solution. A FlexFactory turnkey production line provides end to end services and project management from design through qualification and beyond.

LEARN ABOUT FlexFactory

KUBio modules:

 

 

 

 

 

 

Floor 1

Operations area

 

 

 

 

 

Floor 2

Gowning areas and HVAC installations

 

 

 

 

 

Production area standards

Biosafety level 1 (BSL1)

 

 

 

 

 

mAb output capacity**

KUBio configurations*

Building footprint

Total space

Titer: 2.0

Titer: 3.0

Titer: 4.0

2 x 500 L

1200 m2

2200 m2

28

42

56

 

2 x 1000 L

1200 m2

2200 m2

56

84

112

 

2 x 2000 L

1350 m2

2400 m2

112

168

224

 

4 x 2000 L

1400 m2

2650 m2

224

336

448

*Configurations shown are bioreactors feeding one harvest and downstream processing line, each with an optimized facility footprint.

** Assumptions: 70% recovery through purification, 20 batches per year, per reactor.

Attain supply confidence

Supply chain sustainability programs manage characterization and sourcing of raw materials, product development, and manufacturing of our high-quality products. We help reduce risk to your business by assessing supply weaknesses and taking actions throughout the product lifecycle. 

Read more about security of supply

SoS graphic