Gore unveils new biopharma tools
two new products to assist biomanufacturers.
The firm has launched a new aseptic sampling device - claimed to be the only disposable, completely assembled system for biopharmaceutical fluid sampling. It comes pre-sterilised and pre-assembled according to customer specifications. "Our customers identified a need in the marketplace for such a product," Greg Tronto, business leader of the company said in an interview. Other devices on the market require re-sterilisation and multi-stage assembly to remove and replace the disposable pieces after each use, Tronto explained. "From an industry perspective, this is a major drawback." "The industry is moving in the direction of pre-sterilised and disposable parts of the manufacturing process. People want to focus on manufacturing, not the assembly of equipment," he said. According to Tronto, the disposable unit is cost competitive per sample compared with current products on the market. Although Gore's customers are primarily biopharma firms who manufacture their own products in-house, its clientele of contract manufacturers is growing. The availability of disposable equipment is allowing contract manufacturing organisations (CMOs) to change their business model, enabling them to operate 'flexfactories,' where production can be easily set up according to the different needs of each client and then discarded after each batch. The alternative is that the CMO has to invest in stainless steel equipment dedicated to a single client, as well as clean and validate the equipment for each new batch and new drug being produced in order to avoid cross-contamination, and this is expensive and limits the amount of space and time available to deal with multiple contracts. Meanwhile, Gore PharmBio used Interphex to give a sneak preview of a new online bioprocess configurator, which is due to be launched in June. The tool will provide its customers with the ability to design and build their fluid assemblies customized to their unique needs, via a drag and drop interface. "Through this tool we are pushing customization out to the end user," said Tronto. He explained that it is commonplace for companies to design manufacturing assemblies on a piece of paper, which is then passed on to the company who is providing the equipment and there is often an amount of toing and froing until a final design that suits the company is settled upon. "This is a time consuming and inefficient way of doing things, but with our new programme, customers can design and envisage what they want and electronically send it to us, after which point we provide pricing and place an order," said Tronto. He added that the system will only let companies design "something that will work, to avoid unnecessary engineering designing, and it will also alert customers if they have chosen a custom piece of equipment, and attempt to replace it with a standard piece. "The user interface and the customization is unique to market," said Tronto. "I'm not aware of any other product on the market where you can design an entire tubing set with molded assemblies and custom connections in such a user friendly manner."
