JUNE 22, 2022
By Jeanene Swanson, Senior Marketing Writer, Cytiva
Post-pandemic, the supply chain crisis continues to present challenges to all industries, including biopharmaceutical manufacturing. As suppliers face increased demand, inventory stocks can no longer keep pace, leading to supply chain bottlenecks. For drug manufacturers who rely more and more on single-use technologies (SUT), a lack of capacity among suppliers had led to lower inventories and subsequent interruptions in drug development timelines or unplanned downtimes.
Multi-site manufacturing enhances security of supply
In July 2021, Cytiva and Pall Corporation announced a 1.5 billion USD investment over two years to meet growing demand for biotechnology solutions (1). This includes 300+ million USD toward SUT for expanding operations in the US and the UK, as well as building out a new facility in Cardiff, Wales, to manufacture single-use bioprocessing equipment. In March 2022, Cytiva announced that it had begun to make mixer bags, flow kits, and tubing assemblies at the new site (2).
The benefits of multi-site manufacturing are numerous. Not only does it reduce the risk of supply chain shortages, but it makes transporting goods faster and more sustainable. One of the main benefits is to “reduce lead times,” says Mike Toner, Global Product Manager at Cytiva, resulting in stronger business continuity. Since many customers must audit each Cytiva manufacturing site, all sites must prepare relevant documentation packages for customers that contain required information to support a faster qualification. Then, if one site shuts down for any reason, “we can take demand and split it up among other facilities to reduce the amount of downtime.”
Cytiva’s Carrie Miller, Cell Growth Platform Leader, believes the biggest benefit that comes from an “in-region, for-region” strategy is allowing for backup sites. “If there is anything that happens—a disaster, another pandemic—multiple sites that have ability to manufacture products give customers that security of supply.”
Consistency across sites is key to resilient manufacturing
For biopharma manufacturers, having access to more product is not going to solve the problem in and of itself. Specific regulatory requirements must be met in order for customers to take advantage of multi-site manufacturing. Once a manufacturer validates a source and registers its process (using that source) with the US Food and Drug Association (FDA), for instance, the company is required to validate and register any additional sources. In the case of Cytiva as a supplier, customers who are running a registered process must audit a secondary site and its products before putting them to use in that process.
Cytiva is committed to maintaining quality levels and consistency across multiple manufacturing sites. “When a new line is set up, a process validation is performed,” Mike says. Some product lines go through both R&D and functional testing. “Once the line is set up, the global complaint handling group monitors and records any complaints in our system for all our production facilities.” As a result, Cytiva can quickly identify and resolve quality issues that may be common across sites.
Mike advises customers to “reach out to us with any required information, such as site questionnaires and/or to schedule an audit, so that customers can approve new facilities as soon as possible [and] allow Cytiva to ship the product.”
The challenge: how to futureproof supply in the long term
As a manufacturer who has spent the past two years dealing with supply chain issues, Cytiva is committed to making sure shortages are a thing of the past. The company is “working with our customers on long-term forecasting,” says Camilla Lindgren, Security of Supply Program Leader, at Cytiva. That way, “we will have the opportunity to plan for the future with even greater accuracy.”
Secondly, “we’ve started working on dual sourcing of components, so that if one component becomes out of stock or difficult to get, we can fall back on others,” Mike says.
Third, as mentioned, Cytiva is expanding capacity and building out new sites, like the SUT facility in Cardiff. “By building new sites, we are creating multiple locations that can support various product lines; ensuring we don’t have a situation where a product can only be built in one location, and we don’t have a facility that is only supporting one product; all around securing supply and flexibility” Carrie says.
Single-use technologies are trending upward
SUT offers many advantages over fixed stainless-steel systems, including less need for cleaning and validation as well as less time invested in getting a facility and process line up and running. “In terms of planning, for the majority of SUT, the flexibility of switching between lines for different products is a very good thing,” Camilla says.
SUT is making biopharma manufacturing more efficient, easier, and less expensive—especially for R&D and clinical trials—and offers higher levels of flexibility and fast changeover for those working on multiple products, such as contract development manufacturing organizations (CDMOs). As a result, there is a continuing trend toward increased use of SUT as well as modular bioprocessing facilities, like the Cytiva KUBio™ facility with the FlexFactory™ system (3). Even though SUT advantages must be weighed against setup and disposal costs of new single-use bioreactors, bags, mixing systems and other devices, SUT and modular bioprocessing will, in part, drive future manufacturing resiliency. We encourage customers to take steps as soon as possible to qualify the Cytiva multi-site SUT facilities (e.g., carrying out audits or sending questionnaires) in order to benefit from the enhanced security of supply that multi-site manufacturing offers.
For more information on Cytiva’s security of supply processes and protocols, visit the Cytiva security of supply web page.
- Cytiva. Cytiva and Pall Corporation investing 1.5 billion USD over two years to meet growing demand for biotechnology solutions. Cytiva website. Published July 27, 2021. Accessed April 29, 2022.
- Cytiva. Cytiva supports global biopharma industry with new site in Cardiff, Wales. Cytiva website. Published March 10, 2022. Accessed April 29, 2022.
- BioPlan Associates, Inc. 17th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. Published April 2020. Accessed April 29, 2022.