Scalable Ultracentrifugation Solutions

AWST's continuous flow ultracentrifuges efficiently and reliably separate viruses, virus like particles and viral vectors for the development and manufacture of vaccines, gene therapies, and other bio-products. With the addition of the AWST Automated Fluid Handling (AFH), customers now have a system that fully automates and standardizes critical bio-manufacturing processes. Leaders in Scalable Ultracentrifugation Solutions Alfa Wassermann Separation Technologies (AWST), a subsidiary of Alfa Wassermann Inc., for over 60 years the supplier whose singular purpose has been the support of bioprocess...

Products Overview Continuous flow ultracentrifugation Research & Development Pilot Scale-up Production Scale Develop protocols for the separation, fractionation and concentration of AAV, viral vectors, virus-like particles, viruses, viral and bacterial vaccines, macromolecules and cellular organelles. Sized for scale up process development and pilot scale production, suitable for use in cGMP manufacturing. The KII Ultracentrifuge system is designed for industrial scale production suitable for use in cGMP manufacturing. AFH Automated Fluid Handling Fully automated, customizable fluid handling...

Continuous Flow Ultracentrifuges The KII system is designed to expertly perform in FDA approved processes for the manufacture of viral vaccines, particulate proteins, gene therapies and nanostructures. The KII Ultracentrifuge is the global standard for vaccine manufacturing. This unit is selected more than any other manufacturer's system because of its reliability, funtionality and cost effective operation. Alfa Wassermann’s extensive experience in the design, manufacture, service and support of continuous flow ultracentrifuges in the vaccine manufacturing industry is demonstrated in the KII...

Highly regarded for its versatility, reliability and ease of operation, the KII is the benchmark for quality in the large scale commercial preparation and production of bioprocess materials. Density gradient ultracentrifugation allows concentration and purification in a single step which reduces process time while increasing overall yield and production capacity. Our range of linear scalable rotor cores enables scale up and scale down of process parameters1. The simple fluid path design of KII ultracentrifuge rotors create a low shear environment for maximum viability of virus particles during...

PKII Ultracentrifuge cGMP Pilot Scale Manufacturing The PKII Ultracentrifuge retains all the cGMP capabilities of the KII ultracentrifuge and features scalable rotor design for process development studies or production scale output with one rotor system. This technology platform is designed for efficient, linear scaleup unique to AWST ultracentrifuges. In addition to widespread use for purification, the PKII can be used for large scale clarification applications.

The PKII is manufactured to meet specific customer needs from pilot to small scale production. With a range of linear scale cores, the rotor capacity can be adjusted from 400 mL to 1,600 mL while retaining the same separation parameters as the KII and Promatix 1000 ultracentrifuges. Features include: • Up to 100 L production capacity per batch • Multiple rotor configurations in air turbine or electric motor drive • Throughput up to 60 L/h

AW Promatix 1000 Research and Development with Linear Scalability The Promatix 1000 is designed to develop protocols for the separation, fractionation and concentration of viral vectors, virus-like particles, viruses, viral and bacterial vaccines, macromolecules and cellular organelles.

Fully programmable to run user defined applications. Fully automated for gradient and product loading, continuous flow separation, fraction collection and cleaning. The system provides operators with easy to read continuous displays of operational steps, critical run data and subsystem status. Scalable cores available with the Promatix 1000 enable researchers to utilize continuous flow methodologies with research scale process volumes and eliminate traditional small scale, batch-type processes. The AWST patented core technology allows for linear scalability to full manufacturing scale with no...

Alfa Wassermann's fluid handling system fully automates and standardizes the critical process of fluid filling and fractionation in a selfcontained mobile work station. System design includes: • • • Fluid routing pinch valves Flow rate and direction control pump Flow, pressure, and temperature product sensors AFH software comes pre-loaded with standard fluid handing protocols. Custom protocols that include sanitation, rinsing, filling, fractionation and other methods can be programed on site by the user. Network integration is available to utilize upstream/downstream inputs and outputs via open...

Automated Fluid Management

Linear Scalability Linear scalability delivers operational efficiency and cost savings in the product development race. Only Alfa Wassermann uniquely designed ultracentrifuges are linear scalable. Data analysis of product peaks for each run confirm similar peak height and width in both the KII largescale, PKII Pilot-scale and the Promatix 1000 research scale ultracentrifuge systems. The peak densities are similar in all centrifuge runs. The figures on page 13 describe a similar gradient shape across the Alfa Wassermann range of ultracentrifuges. From the figures both scalability and linearity...

PKII with PK3 Core 1600 mL PKII with PK3 Core 800 mL PKII with PK3 Core 400 mL Absorbance Absorbance Promatix 1000 with PX3 Core 230 mL Legend — Sucrose (%)

Continuous Flow Ultracentrifuges Rotor Specifications and Applications Alfa Wassermann offers a broad range of rotors each uniquely suited to specific particle applications and desired volumes. Rotor volumes range from as little as 0.19 L to 8.4 L for batch or continuous flow operations. Common applications include Influenza, AAV, Adenovirus, Hepatitis B, Rabies, and more. Each rotor assembly is composed of a tubular bowl and two end caps which are made of titanium alloy. Contained within the titanium bowl is the Noryl® rotor core. This assembly forms flow channels down which process material...