The world’s population is getting older and is requiring more effective, often biological-based treatments for endemic diseases such as diabetes and rheumatoid arthritis. “In emerging markets, governments are looking to vaccinate or treat diseases in larger numbers of their population. Many of the big pharmas don’t have blockbusters in their pipeline anymore; now it’s all about producing smaller quantities of a greater variety of targeted vaccines, biologicals, and biosimilars,” explained Scott Ripley, marketing leader EMEA, GE Healthcare Life Sciences.
These trends will drive the demand for greater access to biologicals and vaccines, which will put the emphasis on being flexible and cost-effective to ensure biomanufacturing facilities are working at full capacity.
To drive down manufacturing costs, pharmas need to operate flexible facilities to maximize facility utilization while minimizing the risks associated with multiproduct manufacturing at various stages of clinical development and licensed production.
“In today’s market, facility utilization is key. If you’re not sweating your asset and only making one or two batches of a biological per year, then the cost of goods of that product is going to be very high,” Ripley said. “For many CMOs, for example, every day they don’t use their bioprocessing facilities costs them up to $2 million per day in lost revenues.”
Using traditional stainless steel bioreactors and fixed chromatography and filter systems, it can take anywhere from two to seven years to design and build a plant for specific large-scale production of a monoclonal or vaccine. This is a major gamble because if the product fails at Phase III, manufacturers can be left with a plant they find difficult to reconfigure.
One solution to this capacity and flexibility conundrum is to implement single-use biomanufacturing technology that can be swapped around to adapt to different production campaigns. Single-use bioreactors, for example, are established technology that can increase operational efficiency by reducing change over time. With single-use bioreactors there is no need for cleaning in place and cleaning validation steps, or steam sterilization and cool-down time before a bioreactor can be used.
“Cleaning and sterilizing are not value-added steps in biomanufacturing, so it’s desirable that they are kept to a minimum or removed to improve efficiency,” explained Neil Ross, marketing manager—bioprocess EMEA, GE Healthcare Life Sciences. “The proof is in the application, and there are many examples of biologicals in clinical-stage manufacture being produced quicker than if a traditional stainless steel route was implemented.”
Single-use technology has developed rapidly in the past five years, and it is now possible to implement an end-to-end process from cell to biological using an entirely disposable set-up.
GE Healthcare’s ReadytoProcess™ platform now offers around 250 different types of configurations that scientists could put together for their manufacturing.
“ReadyToProcess is a bit like Lego—you take what you need to get your process up and running and put it all together,” said Jonathan Royce, bioprocess marketing program manager.
“Our complete ReadyToProcess factory in a box is made possible by the use of ReadyMate™ disposable aseptic connectors,” Ross added. “These don’t come as either male or female connectors, which is unique, and they come in a range of sizes for scalable operation. They can be operated at pressures up to 5 bar and the pressure drop can be as low as 0.2 bar at flow rates as high as 6,000 L/hr.”