1. 1
Single-Use Process Systems

2. Designed for cGMP operation with all product contact
surfaces completely disposable –
2

3.  Applications – Research & Clinical
 Cell Culture Harvest
 Purification
 Concentration of Proteins & Vaccines
 Capabilities
 Ultrafiltration; microfiltration; diafiltration
 Can be configured to accommodate various types of UF/MF membrane
elements (e.g. Hollow Fiber; Parallel Plate & Frame; or Spiral)
 Scalable design ranging from Benchtop PD to Production
3

4. Fully Automated Operation
 PLC controlled with HMI graphical touch screen display
 Programs secured to operator access level (Operator; Supervisor;
Process Engineering; etc.)
 Batch record archival of historical data
 Process conditions monitored by full range of single-use sensors
 Flowrate (non-product Ultrasonic)
 Pressure
 Conductivity
 Temperature
 UV optical density
 Patented ARTeSYN® single and multi-valve arrays
 Provide zero dead legs in process flow path
 Utilize quick-replace silicone liners
 Control flow to 2 % and pressure to ± 0.2 PSI
4

5. 5
Designed for cGMP operation with all product contact
surfaces completely disposable

6. 6
 Applications – Research & Clinical
 Contamination removal
 Concentration
 Purification of proteins
 Capabilities
 Elution chromatography – Isocratic and Gradient
 Affinity chromatography – Flow-Thru
 Accommodates chromatography columns of various size ranges
 Scalable design ranging from Benchtop PD to Production

7. Fully Automated Operation
 PLC controlled with HMI graphical touch screen display
 Programs secured to operator access level (Operator; Supervisor;
Process Engineering; etc.)
 Batch record archival of historical data
 Process conditions monitored by full range of single-use sensors
 Ultrasonic flowrate
 Pressure
 Conductivity
 Temperature
 UV absorbance
 Patented ARTeSYN® single and multi-valve arrays
 Provide zero dead legs in process flow path
 Utilize quick-replace silicone liners
 Control flow to 2 % and pressure to ± 0.2 PSI
7

8. 8
In additional to the aforementioned systems described in this
presentation, AlphaBio can provide a variety of scalable
single-use downstream process systems
 Applications – Research & Clinical
 Virus Filtration System
 Buffer/Media-Prep Systems
 In-Line Dilution Systems