Cytiva unveiled the Xcellerex single-use magnetic mixer at INTERPHEX 2024 in New York City on April 16, 2024. The single-use mixing system was designed to combat challenges in large-scale monoclonal antibody (mAb), vaccine, and genomic medicine manufacturing processes. The mixer is offered in 2000 L and 3000 L capacities and can be configured in several ways to accommodate diverse mixing processes. Its compact size benefits facilities with space constraints or complicated installation of large-scale consumables.

According to the company, minor leaks may cause significant delays and losses. “When dealing with a 3000 L batch of cell culture media, the estimated financial loss can cost between $60k to upwards of $100k” (1). The system helps prevent expensive leaks with a novel mixer biocontainer that incorporates user-centered design elements to improve durability and ease of use. The design provides enhanced safeguards and added protection from leaks that may occur during shipping, storage, and operation.

Time taken to mix batches can inhibit product development times, specifically the challenge of mixing floating powders such as cell culture media. Current systems have underpowered impellers with circular or cubical shapes that make producing large volumes challenging, according to Cytiva. This new single-use system “has a powerful impeller that when combined with the mixer’s hexagonal shape creates a vortex, enhancing the interaction at the liquid surface. This vortex effectively pulls down the floating powders into the main body of the liquid to allow for a more efficient and shorter mixing process,” the company stated in a press release.

“We’re tapping into our differentiated portfolio to solve a wide range of challenges for our customers. Our new magnetic mixing system is flexible and capable of meeting the many demands and constraints during buffer and cell culture media preparation,” said Amanda Halford, president, Bioprocess at Cytiva in the release. “By reimagining the design, we’ve tackled some of the biggest obstacles to downtime.”

Cytiva is also working to advance messenger RNA (mRNA) manufacturing. In an interview with Pharmaceutical Technology EuropeTM , Scott Ripley, general manager, Nucleic Acid Therapeutics and Precision Nanosystems at Cytiva, discussed technology that enables the “democratization” of mRNA manufacturing (2). Many mRNA therapies and other types of genetic medicines in clinical development are designed to be delivered with the help of lipid nanoparticles. One such platform is Cytiva’s Precision Nanosystems NanoAssemblr microfluidic-based nanoparticle manufacturing platform, which enables the development of genetic medicines with potentially increased stability, efficacy, yield, and quality of non-viral genetic medicines, according to Ripley.

Ripley was enthusiastic about this platform’s ability to “democratize” the good manufacturing practice (GMP) manufacturing aspects for advanced therapies, while managing to cope with the increased molecular diversity of the molecules being handled.

“For example,” Ripley says, “the mRNA platform is unique in that, on one end of the spectrum, it is vaccinating the planet, on the other end, it’s personalized cancer vaccines.”

Reference

1. Cytiva. Cytiva Unveils Latest Innovation for Large Scale Mab, Vaccine, and Advanced Therapy Manufacturing Processes–The Xcellerex Compact Single-Use Magnetic Mixing System. Press Release. April 16, 2024.
2. Spivey, C. Democratizing GMP Manufacturing for the New Therapeutic Pipeline. PharmTech.com. Nov. 21, 2023.