Cytiva is committed to developing and delivering high-quality, ready-to-use products. That’s why we have initiated in-house manufacturing of Cytiva HyClone™ single-use bags for cell culture products. The program shortens lead times for this essential product, which helps enhance security of supply of liquid cell culture media and buffers delivered within our validated, industry-accepted Cell Culture 1 film. By in-sourcing manufacturing at our cell culture center of excellence in Logan, Utah, we aim to reduce logistical challenges so we can supply products faster and more efficiently. Reduced lead times enable our customers to better manage their liquid cell culture media and buffer inventory and plan effectively to keep their projects on track.
Securing supply with in-house manufacturing of liquid media bags
Cytiva, along with other biopharma manufacturers, continue to face a challenging situation in terms of supply and demand. One of the largest pain points for those involved in process development (PD) and manufacturing is the lack of capacity among suppliers, leading to challenges in procuring materials on time and in full as needed. This can lead to interruptions in the manufacturing process, disrupting the manufacturing timeline or causing unplanned downtime. Sourcing is directly linked to whether there are supply interruptions, delays, and non-availability.
Single-use components—specifically, single-use bags that store liquid cell culture media and buffers—have been particularly affected by supply chain issues. During the COVID-19 pandemic, Cytiva witnessed first-hand how relying on third-party suppliers can negatively affect PD and manufacturing by increasing customer wait times for these essential raw materials. In response, we launched our own production line for single-use bags at our HyClone facility in Logan, Utah. Cytiva previously had to rely on third-party suppliers, which led to unpredictable and long lead times. Now, we can directly supply large volume liquid media in single-use bags made of our validated, industry-accepted (refer to validation materials) HyClone Cell Culture 1 film to customers. Subsequently, lead times will drop to a fraction of the current industry standard, with Cytiva aiming for 6 weeks.
“We used to buy these bags from an outside supplier, and during the pandemic we were heavily constrained,” says Mark Palma, Process Liquids & Buffers Platform Leader at Cytiva. “We couldn’t fulfill liquid product orders because we couldn’t get enough bags.” Setting up a bag manufacturing line in Logan removes that third-party supplier constraint, enabling Cytiva to assume direct control and break down supply chain bottlenecks by reducing lead times. “Shorter lead times on bags allows us to better serve our customers,” Palma says.
Single-use bags offer flexibility in volume and scale
The HyClone single-use bag is a complete storage and transportation system that Cytiva manufactures and supplies directly to customers as part of a finished good product. The product consists of the bag itself (always sold with liquid media or buffer inside) and all the components used in the manufacturing and assembly process. Ensuring that these components are pre-qualified helps protect against delays and increases security of supply.
Jerry Branscomb, Strategic Project Manager at Cytiva, adds: “There’s more than just the film. We also address all the peripheral bag components, [which] encompass the manufacturing processes that we use in building those bags, welding the film, assembling the entire container, and the environment in which we do that.”
These bags offer customers the ability to easily scale up and scale out—not just in terms of media volume, but also the number of bags (for both large and small volume). The bags can be used by both small, early-stage companies as well as large bioprocessing companies looking at more custom solutions. Format size is from 0.5 L up to 1 000 L bag size. “It’s really about what is the customer’s pain point, where are they in the clinical phase,” Palma says, “and then, we have a solution that can help them.” Large volumes can be scaled up; for example, at the smaller end, a customer could buy 100 1 L bags while other larger customers are going to need 14 bags of 1 000 L each. “So, we cover the scale of packaging sizes as well as scale of volumes that they need.”
Customer-focused transition
Cytiva is transitioning current customers from the old to the new bags as seamlessly as possible by incorporating input from the customers on their current and future needs.
“New and existing products will come out in this container by default as per our change notices,” says David C. Jones, Cell Culture Media Business Development Manager at Cytiva. “We will also make these bags available to customers who order custom formulations so they can take advantage of the improved supply.”
For more information on HyClone buffers and process liquids, and to try a complimentary sample of a HyClone single-use bag, visit the Cytiva website.