Choosing your single-use technology supplier
If you have decided to expand your biomanufacturing capacity with single-use technologies, it’s important to develop a detailed set of criteria against which you can assess potential technology suppliers.
Choosing an existing supplier can have its advantages, such as simplifying procurement, but ultimately the decision will depend on a number of contributing factors.
These factors include the technology offering (equipment, systems, and consumables), company and technology reputation, initial capital expenditure, running costs, expected implementation time, availability of on-going service and support, and flexibility as the industry evolves over time.
In all cases, it is essential to find a single-use technology supplier with the potential to be a true partner, working alongside you to meet your objectives now and into the future.
How does your supplier support training?
“We developed a training program in conjunction with GE Healthcare that ran in parallel to the installation of the equipment.” Nick Martin, Head of Operations
5 key considerations when choosing a single-use technology supplier:
1. Assess performance and flexibility
Clearly the technology itself is an important factor. As an industry, we tend to look for and trust sound scientifically proven solutions. This means finding the right balance between having a technology that pushes the boundaries in terms of performance and a proven track record.
To assess performance, first you should look at whether the single-use technology can deliver what it claims, ideally through extensive proof of concept studies. Then, as with any supplier selection, you should think about costs, delivery time, and ability to service.
However, a truly strategic supplier is a company that is thinking about how they can work with you to future-proof your process. This means that they are investing in product manufacturing capacity to best fit your future needs, expanding and improving their product ranges, and having a deep understanding of the processes that you’re running in order to be able to best support your needs going forward.
For contract development and manufacturing organization (CDMO) Fujifilm Diosynth, being able to offer their customers a flexible solution is critical. They aim to support customers all the way from initial clinical trials through to commercial manufacture, and be able to scale-up or scale-out at every stage as needed.
Having already adopted GE Healthcare’s BioProcess™ single-use platform at their site in Research Triangle Park, North Carolina, USA, Fujifilm Diosynth decided to expand their manufacturing site in Billingham, UK, by adding duplicate single-use biomanufacturing capacity to address rising customer needs. This brought flexibility of scale and, importantly, the ability to smoothly and efficiently transfer programs from site to site.
2. Review existing supplier relationships
Single-use technology providers offer unique solutions to support different industry demands. Your choice of supplier will depend on what your needs are and how a given supplier can potentially support your needs.
If you already have experience with single-use technologies in-house or through outsourcing, a logical step is to review these relationships, especially current suppliers, and any previously delivered projects to see what can be leveraged for future projects.
In terms of existing single-use suppliers, Fujifilm Diosynth had worked extensively with GE Healthcare to successfully establish a single-use platform at their North Carolina site. They installed a suite of Xcellerex™ XDR bioreactors, as well as other GE technologies to support biologics process development and cGMP contract manufacturing.
By the end of that project, GE Healthcare became more than just a supplier to Fujifilm Diosynth. They established a close network of single-use experts from both companies, working in partnership. This positive experience certainly strengthened GE Healthcare’s standing in the selection process for choosing a supplier for the Billingham expansion.
3. Understand ability to meet multiple needs
Facing increasing pressures to ensure that projects and processes are working efficiently and are as streamlined as possible is common across all aspects of the industry. As such, it can be beneficial to use suppliers that can meet multiple needs, which also simplifies procurement.
While selection of the right production-scale bioreactor may be the main end goal, it’s important to see what other elements your supplier can offer to support across the complete drug life cycle. You might find that your potential single-use technology supplier is actually already a supplier supporting other elements of your business.
Companies like GE Healthcare offer a broad range of tools, technology, and technical knowhow, spanning R&D, through to process development, and upstream and downstream bioprocessing.
For example, GE Healthcare’s WAVE bioreactors can be used for seed trains and the ÄKTA™ ready chromatography system is designed for large-scale purification. These technologies are supported by UNICORN™ software, which is widely used and recognized as being comprehensive and easy-to-use and enables operators to control multiple pieces of equipment from a single operating system.
4. Determine facility design support capabilities
Before deciding which single-use technology platform and supplier to choose, it’s important to consider how you are going to implement and integrate that technology into your operational footprint. Will this addition fit your existing bioprocess workflow or will you need to create a new workflow?
You should select a single-use technology supplier that has deep expertise across all aspects of biomanufacturing. Ideally, this expertise would span designing new manufacturing capacity to cGMP requirements through to deep operational knowledge across the bioprocessing workflow. In doing so, your potential supplier will be in a position to help you create a single-use facility design that maximizes operational efficiency.
For Fujifilm Diosynth, one of the key reasons they chose to continue to use GE Healthcare as their single-use technology supplier was because of extensive industry knowledge and technical expertise, and the ability to support their facility design.
This included maximizing the efficiency from a control room standpoint, which included proposing a central service area in the middle of the building, opting for relatively low classification rooms where possible, and advising on optimized material and people flow control. In addition, GE Healthcare had the knowledge and experience to be able to advise on how this could be done in accordance with regulatory requirements.
5. Evaluate training capabilities
In order to operate your new single-use facility, your manufacturing operations personnel will need the appropriate training. You, therefore, need to understand what your potential technology supplier offers by way of training.
Depending on your business goals and supporting staff, you might only need a generic, blanket training program. More often, you will need a training program that can be tailored to suit your personnel, their varied skill sets, and bioprocess challenges.
To ensure that Fujifilm Diosynth could start accessing their new biomanufacturing capacity as soon as it was validated, they developed an extensive training program, conducted by GE, which ran in parallel with the installation.
Fujifilm Diosynth was also able to access expert advice on the technology transfer process for moving to a single-use technology-based platform, and received dedicated technical support throughout installation and validation.
In summary, you should choose a supplier that has a track record of quality, a strong supply chain, an ability to deliver, and a deep understanding of your processes. If you can combine that with one that wants to work with you to implement and look for new solutions together, you will have a supplier that can support you going forward.