Alfa Wassermann continuous flow ultracentrifuges meet all the demands of cGMP manufacturing for viral vaccines and viral vector gene therapy products. Over forty years of Alfa Wassermann’s experience has led to the development of a sophisticated and robust ultracentrifuge suitable for running upward of 3000 operational hours a year.
In 1967 this technique was made available commercially by Electro Nucleonics Inc (now Alfa Wassermann). Since then the world leading pharmaceutical manufacturers are utilizing the KII ultracentrifuge to produce purifed Influenza vaccine on a large scale as well as Meningitis, Rabies, Hepatitis B and other vaccines.
Alfa Wassermann provides both the traditional Air Drive or an electric motor to provide the driving force to spin the rotor in the rotor chamber.
The Air Drive is traditionally used in high usage processes where robustness and durability are required.
The ‘e-drive’ electric motor has been developed for stand-alone use with only an electrical supply required. The noise emissions of the e-drive KII are very low and therefore suitable for laboratory use.
A PLC or PC-based control runs the proprietary AWST control interface console software. Critical lubrication and speed control systems are built in with alarms con gured to protect the product and machine from harm.
A clear windows based HMI allows for easy operator interaction. Input of data is via keyboard and touch screen. On screen visual and audible alarms enable unattended operation.
- Lubrication Flow
- Coolant Flow
- Lubrication Level
- Coolant Level
- Temperature Rotor
- Temperature Monitoring
- User ID
- Batch ID
- Rotor ID
- Batch Time
- System Run Time
- Rotor Run Time
Continuous data monitoring to a named batch le throughout the run can
be reviewed on screen and is saved to the system before being transferred to a remote location. User con gurable logging allows only process critical parameters to be trended. Batch data can be transferred to a process control unit or sent to a remote printer.
The system is fully validated for use in cGMP manufacturing processes and is the choice for vaccine manufacturers. The control console regulates and controls all necessary process uids, safety features allow for unattended operation, password security enables compliance to 21 CFR Part 11 and GAMP.
Scale Up & Scale Down of Processes
Density gradient ultracentrifugation allows concentration and purification in a single step, reducing the total number of process steps and process time and therefore increasing the overall yield and production capacity. Selection from a range of linear scalable rotor cores enables scale up and scale down of process parameters. The K3 linear scale cores retain the same separation path but differ in rotor volume, which allows for the exact same process puri cation to be achieved at production scale as well as at pilot scale volumes.
To start purification using the ultracentrifuge clarified harvest material can be processed directly, with no concentration or buffer exchange required. Bulk harvest can be processed without clarification using the integrated pre clari er K6 rotor assembly.
The simple fluid path of the ultracentrifuge rotor creates a low shear environment which helps retain the viability of virus particles during downstream processing. Use of sucrose as a density gradient matrix is widely applied and cost effective for virus like particle puri cation and can easily be removed in subsequent processing.