Case Study: Single-Use Biologics Manufacturing for Long Term Needs

Future-proofing your single-use biomanufacturing capacity

The pharmaceutical and biotech industry makes life-changing and life-giving medicines for patients across the globe. To ensure that we can meet demand, and not endanger patient safety, it is essential to have a strong and secure supply chain with the right suppliers to support the complete drug development lifecycle.

Currently, seven of the top ten drugs in the industry are biologics, and they are forming an increasing share in drug development pipelines. These biologics are often high value, niche drugs that need to be produced in small volume batches, which are well-suited to be manufactured using single-use technologies.

If you, as a pharmaceutical company or contract manufacturing organization, are looking to produce biologics with single-use manufacturing technologies, you need to think about how you can modify your capacity to ensure it remains flexible enough to meet your needs today and into the future.

The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity will meet your long-term needs. It is important to note that these factors are different from those associated with traditional stainless steel technologies.

5 key considerations to future-proof your single-use biomanufacturing capacity:

1. Select a supplier who understands your needs

Making therapeutic drugs is a long-term commitment, so your suppliers must be able to support your biologics manufacturing process now and for years to come. The security of supply of these drugs is clearly of vital importance to the patients, the regulators, and the drug companies themselves.

Drug companies and regulators look upstream into the supply chain to suppliers to ensure that they also have a robust security of supply and can continue to provide key ingredients and components that, in turn, result in the patients receiving the medicines they need.

This means choosing suppliers that not only provide the raw materials, equipment, and consumables you need, but also work with you to understand your business needs, processes, and plans for the future. Choosing an established, committed, global company can help ensure long-term engagement and a solid supplier partnership.

When Fujifilm Diosynth was selecting a single-use technology provider, they were looking for a long-term committed partnership based on trust and a mutual understanding of needs. In GE Healthcare, they identified a partner with a strong heritage, commercial stability, and leadership position in many industrial fields. Their extensive bioprocessing portfolio, including innovative single-use technologies and proven chromatography purification platforms, gave Fujifilm Diosynth the confidence that they had found a long-term partner.

2. Determine credibility in single-use bioprocessing

When choosing a supplier to partner with, it is important to understand and assess the supplier’s relative credibility in terms of both the company itself, and its relevant technology offering. Forcontract development and manufacturing organizations (CDMOs), like Fujifilm Diosynth, who are trying to attract many different types of customers, it is especially important to have supporting technologies that are recognized in the industry.

When Fujifilm Diosynth first decided to add single-use manufacturing capacity to their site in Research Triangle Park, North Carolina, USA, they were early adopters of the technology. Fujifilm Diosynth went through a rigorous selection process for potential single-use suppliers that evaluated the technologies they were looking to implement, as well as the companies themselves.

Technology performance and reputation were certainly key in Fujifilm Diosynth’s decision to choose GE Healthcare’s BioProcess™ Xcellerex™ platform, which they knew would resonate well with their customers.

3. Assess the security of supply program

Only if your supplier’s supply chain is robust, will yours be, too. While there are benefits to outsourcing certain raw materials from a wide supply base, it can also be beneficial to have more control over the supply chain by developing robust solutions with a single strategic partner.

For security in any supply chain, it is important to keep things as simple and robust as possible. There are underlying principles common to all security of supply programs, irrespective of industry or product. Notably, your business continuity and security of supply plans need to be developed based on the specific raw material or finished product and, wherever possible, comply to a recognized accredited standard.

In making its selection, Fujifilm Diosynth established that GE Healthcare had a comprehensive security of supply program in place. This includes ISO 22301 accredited business continuity plans in addition to long-term strategic supply agreements with raw material suppliers, and strategic safety stocks.

This strategy enables GE Healthcare to be able to continue to supply their local and global customers with, for example, single-use components and cell culture media even in the event of any unforeseen supply disruptions affecting production at a given site, such as natural disasters.

Overall, it is important to have visibility throughout the supply chain, including change control programs that enable tracking and tracing of components. This will allow you to see how any issues might potentially impact the supply chain and predetermine contingency plans should these happen.

4. Fulfill regulatory requirements

The biopharmaceutical industry is highly regulated, and those regulations are constantly evolving to keep pace with the dynamic innovative changes being seen almost daily. It is vital to anticipate future regulatory requirements and select a supplier that has the foresight to provide you with “future-proofed” technologies to support your biomanufacturing needs now and going forward.

It is widely expected that regulators will increasingly demand more details and assessments of the impact of single-use technologies on the resulting biopharmaceutical end product.

In anticipation of predicted future regulatory demands, GE Healthcare is investing in broadening the understanding of the impact of extractables and leachables (E&L) and has created a dedicated E&L laboratory at their site in Uppsala, Sweden. Working in collaboration with VR Analytical, the intent is to share compound data, structures, and IDs to support the accurate and complete identification of E&L compounds.

We are also seeing both suppliers and users across the industry becoming active members of trade groups, like BPOG, who have dedicated sub-teams addressing key areas. One area that is receiving increasing interest, specifically from the FDA, is data integrity.

The industry is working together to assess the many data integrity requirements, and pharmaceutical companies often look to their suppliers to take an active role in supporting them. CDMOs like Fujifilm Diosynth and tools and technologies suppliers like GE Healthcare are working together to understand this, and to help their respective customers comply.

5. Ensure customer service and support

When therapeutics are manufactured, they need to be reliably delivered to ensure patient safety. It is crucial that your chosen supplier provides excellent customer support not just during installation, qualification and start-up of your process, but also throughout the life of your products.

Fujifilm Diosynth often runs operations around the clock and needed 24/7 support from a supplier to help rectify any issues. Supply chain robustness must encapsulate high quality service and support to deliver a comprehensive solution that meets the demands of the industry.

Closing remark

In summary, when commissioning new single-use manufacturing capacity, it’s not enough to consider requirements at a single point in time. You have to consider how flexible that capacity is to both suit your needs now and how it can be tailored to suit future needs. You need to evaluate all aspects of the supplier, not just the technology offering to ensure your capacity is future-proofed. By evaluating the considerations discussed here, you should be able to choose a supplier that can give you the confidence that you can reliably deliver life-saving therapeutics to patients now and in the future.

GE Healthcare

Contact GE Healthcare

Marlborough, Massachusetts
100 Results Way
Marlborough, MA 01752
Main: + 1 800 526 3593
cs-us@ge.com

Uppsala, Sweden
Björkgatan 30
SE-751 25 Uppsala
Sweden
Main: +46 18 612 0000
productse@ge.com

Fujifilm Diosynth is a trademark of Fujifilm Diosynth Biotechnologies U.S.A., Inc.

GE, the GE Monogram, BioProcess, and Xcellerex are trademarks of General Electric Company. All other third-party trademarks are the property of their respective owners. © 2017 General Electric Company. All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information.

GE Healthcare Bio-Sciences Corp., 100 Results Way, Marlborough, MA 01752, USA For local office contact information, visit gelifesciences.com/contact