The Patent (6,908,223) was issued in June to Alfa Laval Biokinetics and HyClone Laboratories in a joint development of the mixing technology. Included in the patent is the single-use mixing head, liner, rolling cover seal and tube sets along with the hardware, the filter management and controls.
Culture media, buffers, reagents and other biological materials (base materials) are used extensively by biotech companies in research and development, creating vaccines, producing and purifying proteins, and developing other biologicals.
To be safe and effective for their intended use, these base materials must be pure and sterile. As such, base materials are typically made by specialised manufacturers or end-users that have made large investments in sophisticated equipment and facilities.
"It is pleasing to receive the first patent now as we are expanding globally our sales of our single-use mixing system, powered by HyNetics Technology," said Alex Donofrio, vice president for single-use products at Alfa Laval Biokinetics.
The Hynetics range is a result of a joint venture between HyClone and Alfa Laval Biokinetics. The collaboration has developed a formulation system for manufacturing media and other sterile process liquids for the life sciences industry. This system allows on-site formulation at a customer's facility using a specially designed modular unit that features entirely disposable product contact surfaces.
The HyNetics range of systems extends from a 25-litre unit up to a size of 10,000 litres. Because all the product contact surfaces are single-use, they are simply disposed of after each batch and replaced with a new system.
The huge expense in creating, operating, and maintaining the systems as well as the manufacture of base materials has resulted in biotech companies purchasing the base materials in their final solution form. There are, however, certain drawbacks to this strategy. For example, the base materials in the solution form are primarily water. As such, these materials can be difficult and expensive to transport.
Although the powdered base materials can be stored for an extended period of time under relatively ambient conditions, the final liquid solutions must typically be stored under refrigerated conditions and have a significantly shorter shelf life. Due to the required refrigeration, storage of significant amounts of the base materials in their solution form can be expensive.
"Accordingly, what is needed are systems and components of such systems that enable an end user to hydrate its own base materials into solution form based on its immediate needs but which do not require the highly regulated and labour intensive cleaning and sterilisation processes used by typical manufactures," said Alfa Laval.
Such systems would enable the end user to minimise the storage of large amounts of base material in solution form while enabling it to maximize the use of powdered base materials which are more efficient to transport and store. Manufacturers could also use such systems to simplify their manufacturing processes.