Core Business and Function

The singular purpose of Alfa Wassermann Separation Technologies is to support the bioprocess and pharmaceutical industries by offering expertise in continuous flow ultracentrifugation (UCF) separation applications and fluid handling solutions. AWST operates at the intersection of medical technology (MedTech) and biomanufacturing, designing, manufacturing, servicing, and supporting high-performance equipment. The company???s core function revolves around its continuous flow ultracentrifuges, which are essential for high-yield, consistent, and scalable purification processes.

AWSTs systems are engineered with the specific goal of maximizing product yield, standardizing complex bio-manufacturing processes, and ultimately minimizing overall production costs for their customers. The technology is critical in the purification of complex biological materials. Specifically, its continuous flow ultracentrifuges efficiently and reliably separate and purify: * Viruses * Virus-Like Particles (VLPs) * Viral Vectors (e.g., AAV vectors for gene therapy) * Viral and Bacterial Vaccines * Macromolecules and Cellular Organelles

This capability makes AWST a key supplier to organizations involved in the development and production of cutting-edge pharmaceuticals, including vaccines and gene therapies. The company is recognized for delivering unsurpassed separation of crucial components, such as full and empty AAV capsids, which is a vital quality control metric in the production of Adeno-Associated Virus (AAV) gene therapies.

Products and Services

Alfa Wassermann Separation Technologies offers a portfolio of specialized, linear-scalable cGMP (Current Good Manufacturing Practice) compliant equipment and integrated systems, along with dedicated technical services.

Continuous Flow Ultracentrifuge Product Line

AWST's centrifuges are designed to be linearly scalable, allowing for smooth transition of purification protocols from the research bench to full-scale manufacturing, ensuring consistency and regulatory compliance across all phases of development.

• AW Promatix 1000: Research and Development Scale System The Promatix 1000 is a bio-separation system cGLP (Current Good Laboratory Practice) designed for process development. It is used to create and optimize protocols for the separation, fractionation, and concentration of various bioproducts. As the latest ultracentrifuge addition, it is a fully automated, research-scale, and cGMP compliant system, with its rotors permitting seamless linear scalability to pilot and production volumes.

• PKII: Pilot Scale Ultracentrifuge The PKII is engineered for the intermediate, pilot-scale production volumes, serving as the bridge between R&D and large-scale manufacturing.

• KII: Manufacturing Scale Ultracentrifuge The KII is the floor-standing, high-volume ultracentrifuge dedicated to industrial and manufacturing-scale production. This system is relied upon by leading producers globally for the mass manufacture of vaccines, including influenza vaccines, and other major bio-products.

The continuous flow ultracentrifuge range includes both their industry-leading air-drive technology and newer electric-drive (e-Drive) models. The e-Drive range incorporates a PLC control, integrated refrigeration, and an electric motor drive, which simplifies installation requirements by only necessitating an electrical supply to the clean room.

Automated Fluid Handling System

• AFH (Automated Fluid Handling System) The AFH system is a fully automated and customizable fluid handling solution. It is presented as a self-contained, mobile work station designed to fully automate and standardize critical bio-manufacturing steps. Its primary functions include supporting fluid filling and fractionation processes, which are key for maintaining consistency and integrity in a bioproduction workflow. The addition of the AFH complements AWST's ultracentrifugation systems by providing a complete, integrated process solution.

Services

In addition to their capital equipment, AWST provides comprehensive services to ensure the optimal performance of their systems and the success of their customers' bioprocesses. These services include:

• Standard and Customized Applications Offering flexibility to meet the specific and unique needs of varied bioprocess applications.
• Dedicated Service and Process Support Providing expert technical assistance and support for both the equipment and the complex continuous flow separation protocols.
• Bioprocess Expertise Supporting the bioprocess and pharmaceutical industries with deep technical knowledge in continuous flow separation applications and fluid handling solutions.

By focusing on high-efficiency continuous flow separation and automated fluid management, Alfa Wassermann Separation Technologies remains a critical, behind-the-scenes enabler of the modern biotechnology and pharmaceutical industries.