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HyNetics®, LLC - A Joint Venture with HyClone

HyNetics, LLC is a joint venture by HyClone and Kinetics, formed in December 2001 to market disposable based processing innovations. Kinetics is an established engineering, project management, process systems manufacture and installation company in the biopharm industry while HyClone is a leader in cell culture media, sera, buffers, reagents, and single-use bioprocess container products. Together, through HyNetics they have introduced a means of formulating media and other sterile process liquids on-site at a customer's facility in a modular unit that utilizes entirely disposable product contact surfaces.

There is a rapidly growing demand for manufacturing capacity in the biopharm industry. HyNetics' first product, "a Single-Use Sterile Liquid Formulation System," provides customers with a short lead time modular system to formulate media and buffers locally without the need for CIP and SIP and the elimination of cross contamination. This greatly enhances production time by reducing batch cycle times, which translates to more media/buffer formulation compared to traditional processing. The entire system (bags, distribution tubing, and disposable filter sets) is composed of a unique film that is totally inert and passes USP Class VVI testing. Some key elements of the product are:

• Powdered media (inexpensive to ship and stable to store) or reagents are shipped to the customer. They are hydrated with high purity water in a completely disposable vessel liner (bag) using an innovative disposable mixing system. The formulated solution is filtered and sterilely filled into disposable containers for easy on-site transport. This allows customers to reduce inventory and formulate in a "Just-In-Time" manner.
• The modular process unit is mobile, with short lead-time and rapid on-site installation.
• The process is closed. This allows customers to locate the unit in a "gray" space.
• HyNetics systems can be customized to best fit in with customers' operations and needs.
  
• Scale-up and varying batch sizes are available through a variable volume holding vessel for the formulation bag.
  
• CIP and SIP are eliminated, reducing turnaround time, increasing production and reducing labor, cleaning, and validation costs.
  
• Cross contamination is eliminated; a virgin process contact system is used with each batch.
  
• HyNetics is moving to all contact surfaces being free of animal-derived components (ADCF). Since all surfaces are discarded after use, this will allow true ADCF media and reagent manufacturing.
  
• Potential for human error in liquid preparation is reduced through process automation with PLC control. The level of automation can be tailored to meet your needs.
  
• A "standard" system will permit liquid batch preparation from 250 liters to about 10,000 liters.
  
• A new, unique disposable mixing system solubilizes powders more efficiently than conventional mixing devices.
  
• A mechanical assist is used to lift the powdered media/reagents for top loading the vessel liner.
  
• The powder bag mates with a port on the liner to provide dust-free powder transfer.
  
• A spray ball ensures that all powder is washed from container walls.
  
• A re-circulation system allows for sample removal and supplementation to the mixture.
• A peristaltic pump and filtration train are part of the system.
• A state-of-the-art filler device makes true sterile fills into the container sizes of choice.

Click here to go to the HyNetics web site.