What’s in the box? How the flatpack concept is a winner with biologics manufacturers

As the manufacture of biologics takes on increased significance in the pharmaceutical sector, it’s clear to see why GE Healthcare’s KUBio system is growing in popularity. Lu Rahman paid a visit to the company facility in Uppsala, Sweden to find out why this approach is indeed, so ground-breaking.

If the concept of a biopharmaceutical manufacturing facility arriving in a box seems far-fetched, think again. It’s becoming the norm for GE Healthcare customers. Combining manufacturing excellence with healthcare expertise, the company’s KUBio modular manufacturing solution based on single-use technologies – which is being hailed as a ‘game-changer’ for the biopharmaceutical sector – offers pre-fabricated modules that can be delivered in a shorter time-frame compared with traditional pharmaceutical factory builds. This of course creates cost-efficiency benefits for manufacturers.

It was interesting to learn more about this concept – which has piqued much interest within the biopharmaceutical sector – at GE Healthcare’s Uppsala facility. The manufacture of biologics has grown in recent years: According to Grand View Research, the global biologics market is anticipated to reach $399.5 billion by 2025. Drug manufacturers in this space are therefore looking for cost-effective and efficient ways of bringing their products to market. Investment in a biopharma facility for the development of a new drug usually takes three to four years. At this point the drug is usually only in phase 1 development, highlighting the financial risk of the process can pose. KUBio construction typically takes half the amount of time to be planned, constructed and installed.

KUBio has been designed to provide an innovative off-the-shelf, modular factory that will save manufacturers of biopharmaceuticals time and money. The pre-made modules – equipped with GE Healthcare’s technologies – are assembled at a customer’s chosen site to make a fully functional ready-to-run bioprocessing facility. This says GE Healthcare is faster to install than having to construct a traditional factory.

So how does the system work? Customers are assigned a dedicated project manager from start to finish offering continuous communication between GE Healthcare and the client, and to ensure that the user receives a product to its exact specification. With strong post-delivery support to aid successful installation, training and qualification, the process is designed to offer a premium product that meets the precise needs of the client. KUBio is designed to meet cGMP requirements while optimising manufacturing flexibility and productivity.

Daria Donati, director, business development and innovation enterprise solutions at GE Healthcare Life Sciences, said: “Collaboration is a crucial part of the project and is maintained from start to finish. GE Healthcare expertise is utilised on both the application of the technology and the way we engineer the system. Throughout the process standards are maintained to the highest level to ensure we fulfil the requirements of industrial manufacturing.”

From the initial quote to ten years after-delivery support, GE Healthcare maintains close contact with the customer. The modules are produced in a controlled environment to ensure quality from the start. They include the specific materials required by the customer for that room – electricity, water and ventilation.

“KUBio is a new way of manufacturing biopharmaceuticals, bringing our customers a simplified way to build a facility also allowing them to dramatically decrease/reduce a typical construction time and greatly streamline the whole construction process,” added Donati

The introduction of KUBio expands GE Healthcare’s offering of world-class tools, technologies and services for the biopharmaceutical manufacturing industry, allowing customers to benefit from a range of solutions that can be tailored to meet specific needs, from pilot to commercial scale. GE Healthcare’s KUBio comprises start-to-finish services and single-use technologies, such as Xcellerex and WAVE bioreactors, mixers, filtration and chromatography systems, which are all integrated through a single automation platform.